dofetilide 0.25 mg
INDICATIONS AND USAGE Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES ). Conversion of Atrial Fibrillation/Flutter Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide has not been shown to be effective in patients with paroxysmal atrial fibrillation.
Bionpharma Inc.
CAPSULE ORANGE 711 250 mcg
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HOW SUPPLIED
DOFETILIDE 125 mcg (0.125 mg) capsules are supplied as No. 4 capsules with opaque light orange cap and opaque white body, printed with '125 mcg' in black ink on body and "710" in black ink on cap and are available in:
DOFETILIDE 250 mcg (0.25 mg) capsules are supplied as No. 4 capsules with opaque peach cap and opaque peach body, printed with '250 mcg' in black ink on body and "711" in black ink on cap and are available in:
DOFETILIDE 500 mcg (0.5 mg) capsules are supplied as No. 2 capsules with opaque peach cap and opaque white body, printed with '500 mcg' in black ink on body and "712" in black ink on cap and are available in: 125 mcg (0.125mg) 250 mcg (0.25 mg) 500 mcg (0.5 mg) Obverse '125 mcg' '250 mcg' '500 mcg' Reverse "710" "711" "712" Bottle of 60 69452-131-17 69452-132-17 69452-133-17 Store at controlled room temperature, 15° to 30°C (59° to 86°F). PROTECT FROM MOISTURE AND HUMIDITY. Dispense in tight containers (USP). Rx Only Distributed by: Bionpharma, Inc. Princeton, NJ 08540 Made in India 948026787 Revised: 1/2023
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