flecainide acetate 50 mg
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 also indicated for the prevention of: documented ventricular arrhythmias, such as sustained ventricular tachycardia ( sustained VT), that in the judgment of the physician are life-threatening. Use of Flecainide Acetate Tablets, USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of Flecainide Acetate Tablets, USP is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of Flecainide Acetate Tablets, USP, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. Flecainide Acetate Tablets, USP should not be used in patients with recent myocardial infarction. (See Boxed WARNINGS .) Use of Flecainide Acetate Tablets, USP in chronic atrial fibrillation has not been adequately studied and is not recommended. (See Boxed WARNINGS .) As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of Flecainide Acetate Tablets, USP favorably affects survival or the incidence of sudden death.
epic pharma, llc
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HOW SUPPLIED
FLECAINIDE ACETATE Tablets, USP 50 mg tablet is supplied as a white biconvex round tablet with “YH 777” debossed on one side and plain on the other side. Bottles of 100 tablets with child-resistant closure, NDC 42806-817-01 100 mg tablet is supplied as a white biconvex round tablet with “YH 717” debossed on one side and have a score on the other side. Bottles of 100 tablets with child-resistant closure, NDC 42806-818-01 150 mg tablet is supplied as a white, capsule shaped tablet, with “YH 711” debossed on one side and scored on the other side. Bottles of 100 tablets with child-resistant closure, NDC 42806-819-01 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Adverse reaction contact: Epic Pharma, LLC at 1-888-374-2791 Manufactured by: Yichang Humanwell Oral Solid Dosage Plant Yichang, Hubei, China 443001 Distributed by: Epic Pharma, LLC Laurelton NY, 11413 Rev. 01-2024-00 LN0005
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