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. Its empirical formula is C 31 H 44 N 2 O 5 S, HCl with a relative molecular mass of 593.2. Its structural formula is: MULTAQ is provided as tablets for oral administration. Each tablet of MULTA...

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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. 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 . Verify that females of reproductive potential are not pregnant prior to initiating MULTAQ . One t...

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MULTAQ is contraindicated in patients with: • Permanent atrial fibrillation (patients in whom normal sinus rhythm will not or cannot be restored) • Symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV symptoms • Second or third-degree atrioventricular (AV) block, or sick sinus syndrome (except when used in conjunction with a functioning pacemaker) • Bradycardia <50 bpm • Concomitant use of strong CYP3A inhibitors, such as ketoconazole, itraconazole, v...

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• Determine cardiac rhythm at least once every 3 months. If AF is detected discontinue MULTAQ or cardiovert. • Ensure appropriate antithrombotic therapy prior to and throughout MULTAQ use. • Liver injury: If hepatic injury is suspected, discontinue MULTAQ. • If pulmonary toxicity is confirmed, discontinue treatment. • Hypokalemia and hypomagnesemia: Maintain potassium and magnesium levels within the normal range. • Renal impairment: Monitor renal function periodically. • Embryofetal Toxicity: Based on ...

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Dronedarone is metabolized by CYP3A and is a moderate inhibitor of CYP3A and CYP2D6 and has potentially important pharmacodynamic interactions • Class I or III antiarrhythmics: Contraindicated. • Digoxin: Consider discontinuation or halve dose of digoxin before treatment and monitor digoxin levels. • Calcium channel blockers (CCB): Initiate CCB with low dose and increase after ECG verification of tolerability. ( 7.1 , 7.2 , 7.3 ) • Beta-blockers: May provoke excessive bradycardia. Initiate with low ...

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MULTAQ may cause fetal harm when administered to a pregnant woman. In animal studies, dronedarone administered to pregnant rats and rabbits during the period of organogenesis caused multiple visceral (rats) and skeletal malformations (rats and rabbits) when administered at doses equivalent to or lower than the maximum recommended human dose (MRHD) . There are no available data on dronedarone use in pregnant women to evaluate for a drug-associated risk of major birth defects or miscarriage or other...

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