flecainide 100 mg
INDICATIONS AND USAGE In patients without structural heart disease, flecainide acetate tablets, USP are indicated for the prevention of β paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms β paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide acetate tablets, USP are also indicated for the prevention of β 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 are 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.
aurobindo pharma limited
ROUND WHITE CC 1 2
CC 1 2 ROUND WHITE
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HOW SUPPLIED
FLECAINIDE ACETATE Tablets USP, 50 mg are white to off-white, round, biconvex tablets debossed with βCCβ on one side and β11β on other side. Bottles of 30 NDC 65862-621-30 Bottles of 100 NDC 65862-621-01 Bottles of 1,000 NDC 65862-621-99
FLECAINIDE ACETATE Tablets USP, 100 mg are white to off-white, round, biconvex tablets debossed with β1β and β2β separated by deep score line on one side and βCCβ on other side. Bottles of 30 NDC 65862-622-30 Bottles of 100 NDC 65862-622-01 Bottles of 1,000 NDC 65862-622-99
FLECAINIDE ACETATE Tablets USP, 150 mg are white to off-white, oval, biconvex tablets debossed with β1β and β3β separated by deep score line on one side and βCCβ on other side. Bottles of 30 NDC 65862-623-30 Bottles of 100 NDC 65862-623-01 Bottles of 1,000 NDC 65862-623-99 Store at 20ΒΊ to 25ΒΊC (68ΒΊ to 77ΒΊF) [see USP Controlled Room Temperature] in a tight, light-resistant container. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 038, India Revised: 11/2017
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