Dronedarone

What is Dronedarone?

• Dronedarone (MULTAQ) is an antiarrhythmic drug used for maintaining sinus rhythm for patients with atrial fibrillation or flutter.

Dronedarone

What are the uses of this medicine?

• Dronedarone (MULTAQ) is used to lower the chance that you will need to go into the hospital for atrial fibrillation.
• It is meant for people who have had certain types of atrial fibrillation (paroxysmal or persistent AF) in the past, but are now in normal rhythm.

How does this medicine work?

• Dronedarone (droe ne’ da rone) is a synthetic derivative of amiodarone, a benzofuran derivative that is a structural analogue of thyroid hormone.
• However, unlike amiodarone and thyroxine, dronedarone is not iodinated and was specifically designed to avoid some of the end-organ adverse effects associated with amiodarone use.
• Dronedarone, like amiodarone, has a multitude of electrophysiologic properties, including inhibition of several potassium currents as well as sodium and slow L-type calcium channels.
• In clinical trials, dronedarone improved maintenance of sinus rhythm in patients with atrial fibrillation or flutter.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have a certain type of heart problem called heart block, and you do not have an implanted pacemaker
• have a slow heart rate, less than 50 beats each minute
• have severe liver problems or had liver or lung problems after using amiodarone (a medicine for abnormal heart rhythm)

take certain medicines that can change the amount of MULTAQ that gets into your body. Do not use these medicines with MULTAQ:

• Nefazodone for depression
• Norvir® (ritonavir) for HIV infection
• Nizoral® (ketoconazole), and Sporanox® (itraconazole), and Vfend® (voriconazole) for fungal infections
• Telithromycin and Biaxin® (clarithromycin) for bacterial infections
• Cyclosporine for organ transplant

take certain medicines that can lead to a dangerous abnormal heart rhythm:

• Some medicines for mental illness called phenothiazines
• Some medicines for depression called tricyclic antidepressants
• Some medicines for abnormal heart rhythm or fast heartbeat
• Some medicines for bacterial infection

• are pregnant or plan to become pregnant. It is not known if MULTAQ will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if MULTAQ passes into your breast milk.
• are allergic to dronedarone or any of the other ingredients in MULTAQ.

What drug interactions can this medicine cause?

• MULTAQ and certain other medicines can react with each other, causing serious side effects.

Especially tell your doctor and pharmacist if you take:

• medicine for high blood pressure, chest pain, or other heart conditions
• statin medicine to lower blood cholesterol
• medicine for TB (tuberculosis)
• medicine for seizures
• digoxin (Lanoxin)
• warfarin (Coumadin, Jantoven), a blood thinner medicine
• medicine for organ transplant
• herbal supplement called St. John's wort

• Treatment with Class I or III antiarrhythmics (e.g., amiodarone, flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol) or drugs that are strong inhibitors of CYP3A (e.g., ketoconazole) must be stopped before starting MULTAQ

Is this medicine FDA approved?

• Dronedarone was approved for use in the United States in 2009 and its current indications are for oral treatment of paroxysmal or persistent atrial fibrillation or flutter.

How should this medicine be used?

Recommended dosage:

• The recommended dosage of MULTAQ is 400 mg twice daily in adults. MULTAQ should be taken as one tablet with the morning meal and one tablet with the evening meal.

Administration:

• Take MULTAQ exactly as your doctor tells you.
• Take MULTAQ two times a day with food, once with your morning meal and once with your evening meal.
• Do not stop taking MULTAQ without first talking to your doctor, even if you are feeling well for a long time.
• If you miss a dose, wait and take your next dose at your regular time. Do not take 2 doses at the same time. Do not try to make up for a missed dose.
• If you take too much MULTAQ, call your doctor or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 400 mg film-coated tablets

This medicine is available in fallowing brand namesː

• MULTAQ

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea
• nausea
• vomiting
• stomach area (abdominal) pain
• indigestion
• feeling tired and weak
• skin problems such as redness, rash, and itching

MULTAQ may cause serious side effects, including:

• bradycardia
• Inflammation of the lungs, including scarring and thickening
• Low potassium and magnesium levels in your blood
• Changes in kidney function blood tests after starting MULTAQ

What special precautions should I follow?

• Do not drink grapefruit juice while you are being treated with MULTAQ. Grapefruit juice can increase the amount of MULTAQ in your blood and increase the likelihood that you will have a side effect of MULTAQ.
• MULTAQ doubles the risk of cardiovascular death (largely arrhythmic) and heart failure events in patients with permanent AF. Determine cardiac rhythm at least once every 3 months. If AF is detected discontinue MULTAQ or cardiovert.
• New onset or worsening of heart failure has been reported during treatment with MULTAQ. In patients with permanent atrial fibrillation, dronedarone was associated with an increased risk of stroke, particularly in the first two weeks of therapy. Ensure appropriate antithrombotic therapy prior to and throughout MULTAQ use.
• Hepatocellular liver injury, including acute liver failure requiring transplant, has been reported in patients treated with MULTAQ. If hepatic injury is suspected, discontinue MULTAQ.
• Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported in patients treated with MULTAQ. If pulmonary toxicity is confirmed, discontinue treatment.
• Hypokalemia or hypomagnesemia may occur with concomitant administration of potassium-depleting diuretics. Maintain potassium and magnesium levels within the normal range.
• Marked increase in serum creatinine, pre-renal azotemia and acute renal failure, often in the setting of heart failure or hypovolemia, have been reported in patients taking MULTAQ. Monitor renal function periodically.
• Dronedarone caused fetal harm in animal studies at doses equivalent to recommended human doses. Women of childbearing potential should use effective contraception while using MULTAQ.

What to do in case of emergency/overdose?

Management of overdosage:

• There is no specific antidote available.
• In the event of overdosage, monitor the patient's cardiac rhythm and blood pressure. Treatment should be supportive and based on symptoms.
• It is not known whether dronedarone or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis or hemofiltration).

Can this medicine be used in pregnancy?

• MULTAQ may cause fetal harm when administered to a pregnant woman.
• Pregnancy Category X.

Can this medicine be used in children?

• Safety and efficacy in children below the age of 18 years have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: dronedarone
• Inactive ingredients: hypromellose, starch, crospovidone, poloxamer 407, lactose monohydrate, colloidal silicon dioxide, magnesium stearate, polyethylene glycol 6000, titanium dioxide, carnauba wax

Who manufactures and distributes this medicine?

Manufactured by:

• sanofi-aventis U.S. LLC
• Bridgewater, NJ 08807
• A SANOFI COMPANY

• MULTAQ is a trademark of sanofi-aventis.

What should I know about storage and disposal of this medication?

• Store MULTAQ at room temperature (59°F–86°F or 15°C–30°C).

List of antiarrhythmic agents:

• Amiodarone
• Disopyramide
• Dofetilide
• Dronedarone
• Flecainide
• Ivabradine
• Mexiletine
• Procainamide
• Propafenone
• Quinidine

• Dailymed label info on Dronedarone
• FDA Dronedarone

Dronedarone Resources
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Translate to: East Asian 中文, 日本, 한국어, South Asian हिन्दी, Urdu, বাংলা, తెలుగు, தமிழ், ಕನ್ನಡ,
Southeast Asian Indonesian, Vietnamese, Thai, မြန်မာဘာသာ, European español, Deutsch, français, русский, português do Brasil, Italian, polski List of antiarrhythmic agents:

• Amiodarone
• Disopyramide
• Dofetilide
• Dronedarone
• Flecainide
• Ivabradine
• Mexiletine
• Procainamide
• Propafenone
• Quinidine