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MULTAQ® (dronedarone) tablet

Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.    [  Read the disclaimer    |   <<Back    |    New drug index   ]
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DESCRIPTION CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE CONTRAINDICATIONS
PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED
WARNINGS

WARNINGS  top of page

WARNING: HEART FAILURE
MULTAQ is contraindicated in patients with NYHA Class IV heart failure, or NYHA Class II – III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic [see Contraindications].

In a placebo-controlled study in patients with severe heart failure requiring recent hospitalization or referral to a specialized heart failure clinic for worsening symptoms (the ANDROMEDA Study), patients given dronedarone had a greater than two-fold increase in mortality. Such patients should not be given dronedarone.

(DESCRIPTION) top of page

Initial U.S. Approval: 2009
DESCRIPTION
Dronedarone HCl is a benzofuran derivative with the following chemical name:
N-{2-butyl-3-[4-(3-dibutylaminopropoxy)benzoyl]benzofuran-5-yl} methanesulfonamide, hydrochloride.

Dronedarone HCl is a white fine powder that is practically insoluble in water and freely soluble in methylene chloride and methanol.

MULTAQ is provided as tablets for oral administration.
Each tablet of MULTAQ contains 400 mg of dronedarone (expressed as base).

The inactive ingredients are:
Core of the tablets- hypromellose, starch, crospovidone, poloxamer 407, lactose monohydrate, colloidal silicon dioxide, magnesium stearate.
Coating / polishing of the tablets- hypromellose, polyethylene glycol 6000, titanium dioxide, carnauba wax.

CLINICAL PHARMACOLOGY: top of page

CLINICAL PHARMACOLOGY
Mechanism of Action
The mechanism of action of dronedarone is unknown. Dronedarone has antiarrhythmic properties belonging to all four Vaughan-Williams classes, but the contribution of each of these activities to the clinical effect is unknown.

INDICATIONS AND USAGE  top of page

INDICATIONS AND USAGE
MULTAQ® is indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter geq50 mm or left ventricular ejection fraction [LVEF] <40%), who are in sinus rhythm or who will be cardioverted

CONTRAINDICATIONS top of page

  • Class IV heart failure or symptomatic heart failure with a recent decompensation
  • Second- or third- degree atrioventicular (AV) block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker)
  • Bradycardia <50 bpm
  • Concomitant use of a strong CYP3A inhibitor
  • Concomitant use of drugs or herbal products that prolong the QT interval and may induce Torsade de Pointes
  • Severe hepatic impairment
  • QTc Bazett interval geq500 ms
  • Pregnancy
  • Nursing mothers

PRECAUTIONS top of page


WARNINGS AND PRECAUTIONS
  • Heart failure: If heart failure develops or worsens, consider the suspension or discontinuation of MULTAQ
  • Liver injury: if hepatic injury is suspected, discontinue MULTAQ
  • Hypokalemia and hypomagnesemia: Maintain potassium and magnesium levels within the normal range
  • QT prolongation: Stop MULTAQ if QTc Bazett geq500ms
  • Increase in creatinine: Monitor serum creatinine periodically
  • Teratogen: Women of childbearing potential should use effective contraception while using MULTAQ

DRUG INTERACTIONS
Dronedarone is metabolized by CYP 3A and is a moderate inhibitor of
CYP 3A and CYP 2D6 and has potentially important pharmacodynamic interactions.
  • Antiarrhythmics: Avoid concomitant use
  • Digoxin: Consider discontinuation or halve dose of digoxin before treatment and monitor
  • Calcium channel blockers (CCB): Initiate CCB with low dose and increase after ECG verification of tolerability
  • Beta-blockers: May provoke excessive bradycardia, Initiate with low dose and increase after ECG verification of tolerability
  • CYP 3A inducers: Avoid concomitant use
  • Grapefruit juice: Avoid concomitant use
  • Statins: Follow label recommendations for concomitant use of certain statins with a CYP 3A and P-gP inhibitor like dronedarone
  • CYP 3A substrates with a narrow therapeutic index (e.g., sirolimus and tacrolimus): Monitor and adjust dosage of concomitant drug as needed when used with MULTAQ
  • Warfarin: Monitor INR after initiating dronedarone in patients taking warfarin.

ADVERSE REACTIONS top of page

Most common adverse reactions (=2%) are diarrhea, nausea, abdominal pain, vomiting, and asthenia

DOSAGE AND ADMINISTRATION  top of page

DOSAGE AND ADMINISTRATION
The only 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.

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

HOW SUPPLIED top of page

HOW SUPPLIED/STORAGE AND HANDLING
MULTAQ 400-mg tablets are provided as white film-coated tablets for oral administration, oblong-shaped, engraved with a double wave marking on one side and "4142" code on the other side in:


Bottles of 60 tablets, NDC 0024-4142-60
Bottles of 180 tablets, NDC 0024-4142-18
Bottles of 500 tablets NDC 0024-4142-50
Box of 10 blisters (10 tablets per blister) NDC 0024-4142-10

Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F), [see USP controlled room temperature].

REFERENCE

Package Insert data: 
Issued February 2011
Manufactured by Sanofi Winthrop Industrie
1, rue de la Vierge
33440 Ambares, France

©sanofi-aventis, 2011
All rights reserved.

MULTAQ is a trademark of sanofi-aventis.

The brands listed are the registered trademarks of their respective owners and are not trademarks of sanofi-aventis U.S. LLC.

sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
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