GENERIC NAME: DOFETILIDE - ORAL (doh-FET-ill-ide)
BRAND NAME(S): Tikosyn
WARNING: Though this medication often gives great benefits to people with irregular heartbeat, it may infrequently cause a serious new irregular heartbeat. Therefore, when starting, restarting, or increasing your dose with this drug, your doctor will recommend that you stay in the hospital for at least 3 days for proper monitoring. Before your doctor can prescribe this medication for you, your doctor must have completed the Tikosyn Education Distribution Program. Only pharmacies that have enrolled in the T.I.P.S. program may dispense this medication to you. Talk with your doctor about the benefits and risks of taking this medication.
USES: This medication is used to treat certain types of serious (possibly fatal) irregular heartbeat (such as atrial fibrillation/flutter). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat. Dofetilide is known as an anti-arrhythmic drug. It works by blocking the activity of certain electrical signals in the heart that can cause an irregular heartbeat. Treating an irregular heartbeat can decrease the risk for blood clots, and this effect can reduce your risk of heart attack or stroke.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking dofetilide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth, usually twice daily with or without food or as directed by your doctor. To reduce your risk of serious side effects, it is very important to take this medication exactly as prescribed.The dosage is based on your medical condition, kidney function, and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: Headache, dizziness, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Seek immediate medical attention if any of these rare but serious side effects occur: chest pain, fainting, faster/more irregular heartbeat, severe dizziness.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking dofetilide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver disease.This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.Dofetilide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using dofetilide, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using dofetilide safely.Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: dolutegravir, fingolimod.Many drugs besides dofetilide may affect the heart rhythm (QT prolongation), including amiodarone, pimozide, procainamide, quinidine, saquinavir, sotalol, macrolide antibiotics (such as clarithromycin, erythromycin), and certain quinolone antibiotics (such as sparfloxacin), among others. (See also Precautions section.)Other medications can affect the removal of dofetilide from your body, which may affect how dofetilide works. Examples include hydrochlorothiazide, itraconazole, ketoconazole, megestrol, prochlorperazine, trimethoprim, verapamil, among others.Avoid taking cimetidine while being treated with dofetilide. Ask your doctor or pharmacist about other medications for heartburn/upset stomach.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include dizziness, fainting.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as EKG, kidney function) should be performed before you start dofetilide and periodically during your treatment to monitor your progress or check for side effects. Consult your doctor for more details.
STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised March 2014. Copyright(c) 2014 First Databank, Inc.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.