Country: United States
Language: English
Source: NLM (National Library of Medicine)
FLECAINIDE ACETATE (UNII: M8U465Q1WQ) (FLECAINIDE - UNII:K94FTS1806)
Aurobindo Pharma Limited
FLECAINIDE ACETATE
FLECAINIDE ACETATE 50 mg
ORAL
PRESCRIPTION DRUG
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 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. Flecainide acetate tablets are contraindicated in patients with preexisting second- or third-degree AV block, or with right bundle branch block when associated with a left hemiblock (bifascicular block), unless a pacemaker is present to sustain the cardiac rhythm should complete heart block occur. Flecainide acetate tablets are also contraindicated in the presence of cardiogenic shock or known hypersensitivity to the drug.
Flecainide Acetate Tablets USP, 50 mg are white to off-white, round, biconvex tablets debossed with “CC” on one side and “11” 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 ‘1’ and ‘2’ separated by deep score line on one side and “CC” 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 ‘1’ and ‘3’ separated by deep score line on one side and “CC” 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 20º to 25ºC (68º to 77ºF) [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
Abbreviated New Drug Application
FLECAINIDE ACETATE - FLECAINIDE ACETATE TABLET AUROBINDO PHARMA LIMITED ---------- FLECAINIDE ACETATE TABLETS, USP RX ONLY DESCRIPTION Flecainide acetate is an antiarrhythmic drug available in tablets of 50 mg, 100 mg, or 150 mg for oral administration. Flecainide acetate is benzamide, N-(2-piperidinyl-methyl)-2,5-bis (2,2,2-trifluoroethoxy)- monoacetate. The structural formula is given below. Flecainide acetate USP is a white to slightly off-white, crystalline powder with a pK of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C. Flecainide acetate tablets, USP also contain: croscarmellose sodium, hydrogenated vegetable oil type 1, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. CLINICAL PHARMACOLOGY Flecainide acetate has local anesthetic activity and belongs to the membrane stabilizing (Class 1) group of antiarrhythmic agents; it has electrophysiologic effects characteristic of the IC class of antiarrhythmics. ELECTROPHYSIOLOGY In man, flecainide acetate produces a dose-related decrease in intracardiac conduction in all parts of the heart with the greatest effect on the His-Purkinje system (H-V conduction). Effects upon atrioventricular (AV) nodal conduction time and intra-atrial conduction times, although present, are less pronounced than those on ventricular conduction velocity. Significant effects on refractory periods were observed only in the ventricle. a Sinus node recovery times (corrected) following pacing and spontaneous cycle lengths are somewhat increased. This latter effect may become significant in patients with sinus node dysfunction. (See WARNINGS.) Flecainide acetate causes a dose-related and plasma-level related decrease in single and multiple PVCs and can suppress recurrence of ventricular tachycardia. In limited studies of patients with a history of ventricular tachycardia, flecainide acetate has been successful 30 to 40% of the time in fully suppressing the inducibility of arrhythmias by programmed electrical stimulation. Based on PVC suppression, it appear Read the complete document