Multaq Dosage/Direction for Use

Treatment should be initiated and monitored only under specialist supervision (see Precautions).
Treatment with dronedarone can be initiated in an outpatient setting.
Treatment with Class I or III antiarrhythmics (such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone) must be stopped before starting dronedarone. There is limited information on the optimal timing to switch from amiodarone to dronedarone. It should be considered that amiodarone may have a long duration of action after discontinuation due to its long half-life. If a switch is envisaged, this should be done under the supervision of a specialist (see Contraindications and Pharmacology: Pharmacodynamics under Actions).
Posology: The recommended dose is 400 mg twice daily in adults. It should be taken as one tablet with the morning meal and one tablet with the evening meal.
Grapefruit juice should not be taken together with dronedarone (see Interactions).
If a dose is missed, patients should take the next dose at the regular scheduled time and should not double the dose.
Special populations: Paediatric Population: The safety and efficacy of MULTAQ in children aged below 18 years of age have not yet been established. No data are available.
Elderly: Efficacy and safety were comparable in elderly patients who did not suffer from other cardiovascular diseases and younger patients. In patients ≥75 years old, clinical signs of heart failure and ECG should be monitored on a regular basis when co-morbidities are present (see Contraindications, Precautions and Pharmacology: Pharmacodynamics under Actions). Although plasma exposure in elderly females was increased in a pharmacokinetic study conducted in healthy subjects, dose adjustments are not considered necessary (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Hepatic impairment: Dronedarone is contraindicated in patients with severe hepatic impairment because of the absence of data (see Contraindications and Precautions). No dose adjustment is required in patients with mild or moderate hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: Dronedarone is contraindicated in patients with severe renal impairment (creatinine clearance (CrCl) <30 ml/min) (see Contraindications). No dose adjustment is required in other patients with renal impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Method of administration: Oral use.
It is recommended to swallow the tablet whole with a drink of water during a meal. The tablet cannot be divided into equal doses.