Dronedarone

Conditions Treated

Dronedarone is used to treat people who have had atrial fibrillation (a heart rhythm disorder that may cause the heartbeat to be fast and irregular) or atrial flutter (a heart rhythm disorder that may cause the heartbeat to be fast but regular) during the past 6 months and who also have certain other conditions that increase the risk that they will develop heart problems. Dronedarone decreases the risk that people who have these conditions will need to be hospitalized to treat heart problems. Dronedarone is in a class of medications called antiarrhythmics. It works by helping the heart to beat normally.

Possible Side Effects

What Side Effects Can This Cause?

Dronedarone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• heartburn
• weakness
• rash
• redness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• shortness of breath
• wheezing
• chest tightness
• coughing up frothy mucus
• difficulty sleeping due to breathing problems
• need to prop yourself up with extra pillows in order to breathe at night
• weight gain (of 5 or more pounds) in a short period of time
• swelling of the feet or legs
• slowed heartbeat
• fainting
• fever
• flu-like symptoms
• yellowing of the skin or eyes
• itching
• unusual bruising or bleeding
• nausea
• vomiting
• loss of appetite
• pain in the upper right part of the stomach
• tiredness or lack of energy
• unusual darkening of the urine
• light colored stools

Dronedarone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication Be Used

Dronedarone comes as a tablet to take by mouth. It is usually taken twice a day, with the morning meal and the evening meal. Take dronedarone at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dronedarone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Dronedarone will help control your heartbeat only as long as you continue to take it. Continue to take dronedarone even if you feel well and have felt well for a long time. Do not stop taking dronedarone without talking to your doctor.

What Dietary Instructions Should I Follow

Do not eat grapefruit or drink grapefruit juice while taking this medication. Unless your doctor tells you otherwise, continue your normal diet.

Are There Any Special Instructions

Before taking dronedarone, tell your doctor and pharmacist if you are allergic to dronedarone, any other medications, or any of the ingredients in dronedarone tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients. tell your doctor if you are taking any of the following medications: certain antidepressants such as amitriptyline (in Limbitrol), amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); certain antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend); clarithromycin (Biaxin); cyclosporine (Gengraf, Neoral, Sandimmune); erythromycin (E.E.S., E-Mycin, Erythrocin); medications for irregular heartbeat such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), flecainide (Tambocor), propafenone (Rythmol), quinidine, and sotalol (Betapace); nefazodone; phenothiazine medications for mental illness or nausea; ritonavir (Norvir); or telithromycin (Ketek). Your doctor may tell you not to take dronedarone if you are taking one or more of these medications. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: anticoagulants (blood thinners) such as warfarin (Coumadin); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); calcium channel blockers such as diltiazem (Cardizem, Dilacor, Tiazac), nifedipine (Adalat, Procardia), and verapamil (Calan, Covera, Isoptin, Verelan); carbamazepine (Epitol, Equetro, Tegretol); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor); digoxin (Lanoxicaps, Lanoxin); diuretics (water pills); phenobarbital; phenytoin (Dilantin); rifampin (Rifadin, Rimactane); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); sirolimus (Rapamune); and tacrolimus (Prograf). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor what herbal products you are taking, especially St. John's wort. tell your doctor if you have any other heart problems such as a fast heartbeat, a long QT interval (a heart problem that may cause irregular heartbeat, fainting, or sudden death), or liver disease. Your doctor may tell you not to take dronedarone. tell your doctor if you have or have ever had any other medical conditions.