FULL PRESCRIBING INFORMATION 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 greaer than 70, hypertension, diabetes, prior
cerebrovascular accident, left atrial diameter greater than or equal to 50 mm or left ventricular
ejection fraction [LVEF] less than 40%), who are in sinus rhythm or who will be
cardioverted [see Clinical Studies ].
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 [see Contraindications (4) ].
DOSAGE FORMS AND STRENGTHS
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.
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 54868-3086-0
Store at 25°C (77°F): excursions permitted to 1530°C (5986°F),
[see USP controlled room temperature].