This medicine is an antiarrhythmic used to decrease the risk of needing to go to the hospital for a certain type of irregular heartbeat called atrial fibrillation in certain patients with a history of this type of irregular heartbeat.
Follow the directions for using this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. Take this medicine by mouth with food, such as with the morning and evening meals, unless your doctor tells you otherwise. AVOID EATING GRAPEFRUIT OR DRINKING GRAPEFRUIT JUICE while taking this medicine. STORE THIS MEDICINE at room temperature between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container, away from heat, moisture, and light. KEEP THIS MEDICINE out of the reach of children and away from pets. Take this medicine regularly to receive the most benefit from it. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, skip the missed dose and go back to your regular dosing schedule. DO NOT take 2 doses at once.
WARNING: THIS MEDICINE SHOULD NOT BE USED in patients with severe (class IV) heart failure. It should also not be used in patients with heart failure who have recently had worsening symptoms that required hospitalization. The risk of death may be increased in these patients. THIS MEDICINE SHOULD NOT BE USED in patients with a certain type of irregular heartbeat called permanent atrial fibrillation. The risk of death, stroke, and hospitalization for heart failure may be increased in these patients. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking carbamazepine, hydantoins (eg, phenytoin), phenobarbital, primidone, rifamycins (eg, rifampin), or St. John's wort. DO NOT TAKE THIS MEDICINE if you are also taking another antiarrhythmic (eg, amiodarone, dofetilide, flecainide, sotalol), asenapine, certain azole antifungals (eg, ketoconazole, itraconazole, voriconazole), citalopram, clozapine, cobicistat, cyclosporine, fingolimod, halofantrine, haloperidol, macrolide antibiotics (eg, erythromycin, clarithromycin), maprotiline, nefazodone, nilotinib, ondansetron, paliperidone, phenothiazines (eg, thioridazine), protease inhibitors (eg, boceprevir, ritonavir), quetiapine, telithromycin, tetrabenazine, tricyclic antidepressants (eg, amitriptyline), vardenafil, or any other medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking other prescription or nonprescription medicines (eg, used for allergies, blood thinning, cancer, chest pain, depression or other mental or mood problems, drug or other substance abuse or dependence, heartburn, hepatitis C, high blood pressure, high cholesterol, HIV, immune system suppression, infections, irregular heartbeat or other heart problems, multiple sclerosis, nausea and vomiting, pain, seizures, swelling or fluid retention, Tourette syndrome), multivitamin products, or herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo). Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with this medicine. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of other heart problems (eg, heart failure, irregular heartbeat other than atrial fibrillation), electrolyte problems (eg, low blood potassium or magnesium), liver problems, kidney problems, allergies, pregnancy or if you are able to become pregnant, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have permanent atrial fibrillation (atrial fibrillation that will not or cannot be changed back to a regular heartbeat); you have severe (class IV) heart failure; you have heart failure and have recently had worsening symptoms that required hospitalization; you have second- or third-degree heart block or sick sinus syndrome, unless you have a pacemaker; you have a very slow heartbeat or certain other types of irregular heartbeat; or you have severe liver problems. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have developed liver or lung problems after using another antiarrhythmic medicine called amiodarone. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are pregnant, may become pregnant, or are breast-feeding. Contact your doctor or pharmacist if you have any questions about taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include diarrhea, indigestion, mild stomach pain, nausea, tiredness, vomiting, or weakness. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience chest pain; cough; new or worsening irregular heartbeat; slow heartbeat; symptoms of heart failure (eg, swelling of the hands, ankles, legs, or feet; shortness of breath; wheezing; sudden unexplained weight gain; coughing up frothy mucus at rest, at night, or after minor exercise; trouble sleeping because of breathing problems); or symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools, nausea, vomiting, or loss of appetite; right-sided stomach pain; fever; fatigue; unexplained itching; general feeling of being unwell). AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms of overdose may include fainting; severe dizziness; or slow or irregular heartbeat.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.