Dronedarone, Oral droh-NEH-da-rone

What are other names for this medicine?

Type of medicine: antiarrhythmic (treats irregular heartbeat)

Generic and brand names: dronedarone, oral; Multaq

What is this medicine used for?

This medicine is taken by mouth to reduce the risk that you will need to go into the hospital for heart problems caused by certain kinds of irregular heart rhythms.

It may be used for other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• heart failure, or any other type of heart disease or heart problems, or if you have a pacemaker or defibrillator
• liver disease
• problems with low levels of potassium or magnesium in the blood

This medicine is not for people with severe heart failure. People with severe heart failure who take this medicine have an increased chance of dying. You should not be prescribed this medicine if:

• any physical activity causes shortness of breath or you have shortness of breath while at rest or after a small amount of exercise
• you were hospitalized for heart failure within the last month, even if you are better now
• you have permanent atrial fibrillation (irregular heartbeat)

There are many medicines that should NOT be taken while you are taking this medicine. Tell your healthcare provider about all prescription medicines, nonprescription medicines, and natural remedies you take. Do not start or stop any medicine or supplement unless you check with your healthcare provider or pharmacist first.

Females of childbearing age: Do not take this medicine if you are pregnant. This medicine has been reported to cause birth defects. Talk with your healthcare provider about effective birth control methods while you are taking this medicine. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

How do I use it?

This medicine is first given while you are in the hospital. Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill. Ask your healthcare provider or pharmacist about anything you do not understand.

Take this medicine exactly as your healthcare provider prescribes. Do not take more or less than prescribed. Taking too much of this medicine may cause side effects that could be fatal. Do not stop taking this medicine without your healthcare provider's approval, even if you feel better.

Take the medicine at the same times each day, with your morning meal and evening meal. Always take it with food.

What if I miss a dose?

Do not miss a dose. If you miss a dose, wait and take the next dose at your regular time. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: weakness, slow or irregular heartbeat, lightheadedness, fainting.

What should I watch out for?

This medicine may cause liver damage. If while taking this medicine you develop weakness, tiredness, loss of appetite, stomach pain, vomiting, unusual darkening of urine, or yellowing of your skin or eyes, contact your healthcare provider right away.

Your healthcare provider will need to need to see you regularly to see how this medicine affects you. You may need regular checks of your heart rhythm and blood tests while taking this medicine. Keep all appointments.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Shortness of breath, painful breathing, wheezing when you rest, cough, fever, rapid weight gain of more than 5 pounds, increased swelling of feet or legs, palpitations, slow heartbeat (less than 60 beats per minute), new or worsening irregular heartbeat, chest pain or discomfort, severe dizziness or fainting, trouble sleeping due to breathing problems, dark urine, light colored bowel movements, yellowish skin or eyes, unusual tiredness.

Other: Nausea, vomiting, diarrhea, abdominal pain, indigestion, weakness, rash, itching, change in taste, sensitivity to sunlight.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• alfuzosin (Uroxatral)
• antiarrhythmics such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), flecainide (Tambocor), procainamide, propafenone (Rythmol), and quinidine
• antibiotics such as azithromycin (Zithromax), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (Ery-Tabs, E.E.S.), gemifloxacin (Factive), isoniazid, levofloxacin (Levaquin), metronidazole (Flagyl), norfloxacin (Noroxin), ofloxacin (Floxin), pentamidine (NebuPent), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane), telithromycin (Ketek), and trimethoprim (Primsol)
• antidepressants such as amitriptyline, desipramine (Norpramin), doxepin, fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), mirtazapine (Remeron), nefazodone, nortriptyline (Pamelor), paroxetine (Paxil), sertraline (Zoloft), and trazodone
• antifungals such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend)
• anti-HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), efavirenz (Sustiva), etravirine (Intelence), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• antinausea medicines such as dolasetron (Anzemet) and ondansetron (Zofran)
• antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• antiseizure medicines such as carbamazepine (Tegretol), fosphenytoin (Cerebyx), phenobarbital, phenytoin (Dilantin), and primidone (Mysoline)
• apomorphine (Apokyn)
• arsenic trioxide (Trisenox)
• artemether/lumefantrine (Coartem)
• benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), clorazepate (Tranxene), diazepam (Valium), flurazepam, temazepam (Restoril), and triazolam (Halcion)
• beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), pindolol, propranolol (Inderal LA), and sotalol (Betapace)
• bosentan (Tracleer)
• budesonide (Entocort EC)
• calcium channel blockers such as amlodipine (Norvasc), bepridil (Vascor), diltiazem (Cardizem, Dilacor), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Procardia, Adalat), nimodipine (Nimotop), nisoldipine (Sular), and verapamil (Calan, Isoptin)
• cholesterol-lowering medicines such as atorvastatin (Lipitor), cholestyramine (Questran), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor)
• cimetidine (Tagamet)
• conivaptan (Vaprisol)
• dabigatran (Pradaxa)
• dextromethorphan, an ingredient in many cough and cold medicines such as Robitussin-DM
• digoxin (Lanoxin)
• diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• foscarnet (Foscavir)
• imatinib (Gleevec)
• immunosuppressants such as cyclosporine (Gengraf, Sandimmune, Neoral), sirolimus (Rapamune), and tacrolimus (Prograf)
• loratadine (Alavert, Claritin)
• medicine that reduces the chance of blood clots forming such as warfarin (Coumadin) and clopidogrel (Plavix)
• methotrexate (Rheumatrex)
• octreotide (Sandostatin)
• pain medicines such as fentanyl (Actiq, Fentora, Sublimaze, Duragesic) and methadone (Dolophine, Methadose)
• phenothiazines such as chlorpromazine, prochlorperazine, perphenazine, promethazine (Phenergan), thioridazine, and trifluoperazine
• quinine
• ranolazine (Ranexa)
• St. John's wort
• tolterodine (Detrol, Detrol LA)

The effects of this medicine may be increased if you take it with grapefruit juice. Talk with your healthcare provider about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.