Dronedarone (1 brand name, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- DRONEDARONE
Boxed Warning
In patients with symptomatic heart failure and recent decompensation requiring hospitalization or NYHA Class IV heart failure, MULTAQ doubles the risk of death [see Clinical Studies (14.3)]. MULTAQ is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure [see Contraindications (4), Warnings and Precautions (5.1)]. In patients with permanent atrial fibrillation, MULTAQ doubles the risk of death, stroke and hospitalization for heart failure [see Clinical Studies (14.4)]. MULTAQ is contraindicated in patients in atrial fibrillation (AF) who will not or cannot be cardioverted into normal sinus rhythm [see Contraindications (4), Warnings and Precautions (5.2)].
Indications and Usage
MULTAQ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14)].
Dosage and Administration
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 [see Contraindications (4)]. Verify that females of reproductive potential are not pregnant prior to initiating MULTAQ [see Warnings and Precautions (5.10), Use in Specific Populations (8.1, 8.3)].
Contraindications
MULTAQ is contraindicated in patients with: •Permanent atrial fibrillation (patients in whom normal sinus rhythm will not or cannot be restored) [see Boxed Warning, Warnings and Precautions (5.2)] •Symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV symptoms [see Boxed Warning, Warnings and Precautions (5.1)] •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, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, and ritonavir [see Drug Interactions (7.2)] •Concomitant use of erythromycin [see Clinical Pharmacology (12.3)] •Concomitant use of drugs or herbal products that prolong the QT interval and might increase the risk of torsade de pointes, such as phenothiazine antipsychotics, tricyclic antidepressants, certain oral macrolide antibiotics, and Class I and III antiarrhythmics •Liver or lung toxicity related to the previous use of amiodarone •QTc interval >500 ms or PR interval >280 ms •Severe hepatic impairment •Hypersensitivity to the active substance or to any of the excipients
Adverse Reactions
The following safety concerns are described elsewhere in the label: •New or worsening heart failure [see Warnings and Precautions (5.4)] •Liver Injury [see Warnings and Precautions (5.5)] •Pulmonary toxicity [see Warnings and Precautions (5.6)] •Hypokalemia and hypomagnesemia with potassium-depleting diuretics [see Warnings and Precautions (5.7)] •QT prolongation [see Warnings and Precautions (5.8)]
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.
Overdosage
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). There is no specific antidote available.