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NDC 16729-0490-12

Dofetilide .125 mg/1 CAPSULE

Accord Healthcare, Inc.

Available — 2-Day Shipping
NDC
16729-0490-12
Generic Name
Dofetilide
Brand Name
Dofetilide
Strength
.125 mg/1
Dosage Form
CAPSULE
Route
ORAL
Package Size
—
Labeler
Accord Healthcare, Inc.

FDA Drug Information

Indications & Usage

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 fibri…

Important Warnings

WARNINGS Ventricular Arrhythmia Dofetilide can cause serious ventricular arrhythmias, primarily Torsade de Pointes (TdP) type ventricular tachycardia, a polymorphic ventricular tachycardia associated with QT interval prolongation. QT interval prolongation is directly related to dofetilide plasma concentration. Factors such as reduced creatinine clearance or certain dofetilide drug interactions wil…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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Other Dofetilide NDC Codes

16729-0491-12.25 mg/1CAPSULE
2-Day
16729-0492-12.5 mg/1CAPSULE
2-Day

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