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NDC 62559-0382-01

Flecainide Acetate Tablet 150 mg/1 TABLET

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NDC
62559-0382-01
Generic Name
Flecainide Acetate Tablet
Brand Name
Flecainide Acetate
Strength
150 mg/1
Dosage Form
TABLET
Route
ORAL
Package Size
Labeler
ANI Pharmaceuticals, Inc.

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE In patients without structural heart disease, Flecainide Acetate Tablets USP are indicated for the prevention of: • paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms • paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide Acetate Tablets USP are a…

Important Warnings

WARNINGS Mortality Flecainide acetate was included in the National Heart Lung and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicenter, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than six days but less than two years previously. An excessive mortality or non-fatal…

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

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