dofetilide 0.5 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 capsules 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 capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.
Novadoz Pharmaceuticals LLC
CAPSULE ORANGE MD 3
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HOW SUPPLIED
DOFETILIDE 125 mcg (0.125 mg) capsules are supplied as Size “4†hard gelatin capsules with white opaque body imprinted with “1†with black color band and light orange opaque cap imprinted with “MD†in black ink are available in:
DOFETILIDE 250 mcg (0.25 mg) capsules are supplied as Size “4†hard gelatin capsules with peach opaque body imprinted with “2†with black color band and peach opaque cap imprinted with “MD†in black ink are available in:
DOFETILIDE 500 mcg (0.5 mg) capsules are supplied as Size “2†hard gelatin capsules with white opaque body imprinted with “3†with black color band and peach opaque cap imprinted with “MD†in black ink are available in: 125 mcg (0.125 mg) 250 mcg (0.25 mg) 500 mcg (0.5 mg) Body 1 2 3 Cap MD MD MD Bottle of 60 72205-039-60 72205-040-60 72205-041-60 Unit dose/40 72205-039-37 72205-040-37 72205-041-37 Store at 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature]. PROTECT FROM MOISTURE AND HUMIDITY. Dispense in tight (USP), child-resistant containers. Rx only Manufactured by: MSN Laboratories Private Limited Telangana – 509 228, INDIA Distributed by: Novadoz Pharmaceuticals LLC Piscataway, NJ 08854-3714 Issued on: February 2020
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