Tikosyn®(dofetilide)

TIKOSYN can cause serious cardiac side effects, including a potentially fatal abnormal heartbeat pattern. Treatment initiation requires a 3-day hospital stay for monitoring heart rate and kidney function. Patients must take their exact prescribed dose at home. Monitoring for signs of irregular heartbeat is essential during therapy. Seek immediate medical attention if experiencing: fainting, dizziness, or rapid heartbeat.

A prescription medication for treating irregular heartbeat conditions (atrial fibrillation or atrial flutter). Safety and effectiveness in patients under 18 years have not been established.

Do not use if you have: long QT syndrome, kidney problems or dialysis dependence, or allergy to dofetilide or any medication ingredients. Do not take concurrently with: cimetidine (TAGAMET products), verapamil (CALAN, COVERA-HS, ISOPTIN, VERELAN, TARKA), ketoconazole (NIZORAL, XOLEGEL, EXTINA), trimethoprim alone (PROLOPRIM, TRIMPEX), trimethoprim/sulfamethoxazole combination (BACTRIM, SEPTRA, SULFATRIM), prochlorperazine (COMPAZINE, COMPO), megestrol (MEGACE), dolutegravir (TIVICAY), or hydrochlorothiazide alone or in combinations (ESIDRIX, EZIDE, HYDRODIURIL, HYDRO-PAR, MICROZIDE, ORETIC). Consult your doctor about any medications if unsure of interactions.

Disclose all medical conditions including: cardiac problems, kidney or liver dysfunction, pregnancy plans or current pregnancy, and breastfeeding plans. Additional disclosures needed for: heart condition treatments, blood pressure management medications, mental health medications (depression, anxiety), asthma treatments, allergy/hay fever medications, skin condition treatments, and infection treatments. Important: Maintain a current medication list including all prescription drugs, over-the-counter products, vitamins, dietary supplements, and herbal remedies. Some medication combinations with TIKOSYN increase abnormal heartbeat risk.

Take exactly as prescribed by your doctor. Do not adjust dosage without medical guidance. Medical tests required before and during treatment. Continue taking until doctor directs otherwise. If a dose is missed, take the next dose at the regular scheduled time (do not double doses). May be taken with or without food. In case of overdose, contact emergency services immediately with medication bottles.

Most common side effects: headache, chest pain, and dizziness. Electrolyte imbalance warning signs requiring immediate physician contact: severe diarrhea, unusual sweating, vomiting, appetite loss, and excessive thirst. Report any bothersome or persistent side effects to your healthcare provider. Contact the FDA at 1-800-FDA-1088 to report side effects.

Store at 59-86 degrees F (15-30 degrees C). Protect from moisture and humidity. Keep in tightly sealed container. Store away from children and pets.

Medications are sometimes prescribed for conditions not listed in guidance materials. Use only as prescribed for your specific condition. Do not share with others, even if their symptoms appear similar.

Active Ingredient: Dofetilide. Inactive Ingredients: Capsule fill includes microcrystalline cellulose, corn starch, colloidal silicon dioxide, and magnesium stearate. Capsule shell includes gelatin, titanium dioxide, and FD&C Yellow 6. Imprinting ink includes iron oxide black, shellac, n-butyl alcohol, isopropyl alcohol, propylene glycol, and ammonium hydroxide.