Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
FLECAINIDE ACETATE (UNII: M8U465Q1WQ) (FLECAINIDE - UNII:K94FTS1806)
Hikma Pharmaceuticals USA Inc.
FLECAINIDE ACETATE
FLECAINIDE ACETATE 50 mg
ORAL
PRESCRIPTION DRUG
In patients without structural heart disease, flecainide acetate is indicated for the prevention of: Flecainide acetate is also indicated for the prevention of: Use of flecainide acetate for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate 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, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. Flecainide acetate should not be used in patients with recent myocardial infarction. (See Boxed WARNINGS.) Use of flecainide acetate 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 favorably affects survival or t
Flecainide Acetate Tablets, USP 50 mg tablet is supplied as a white, round, biconvex tablet with product identification “54 024” debossed on one side and plain on the other side. NDC 0054-0010-21: Bottle of 60 Tablets NDC 0054-0010-25: Bottle of 100 Tablets NDC 0054-0010-20: 10x10 Unit-Dose Tablets 100 mg tablet is supplied as a white, round, biconvex tablet with product identification “54 070” debossed on one side and a deep bisect on the other. NDC 0054-0011-21: Bottle of 60 Tablets NDC 0054-0011-25: Bottle of 100 Tablets NDC 0054-0011-20: 10x10 Unit-Dose Tablets 150 mg tablet is supplied as a white, capsule shaped, biconvex tablet with product identification “54 150” debossed on one side and a score on the other. NDC 0054-0012-21: Bottle of 60 Tablets NDC 0054-0012-25: Bottle of 100 Tablets NDC 0054-0012-20: 10x10 Unit-Dose Tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000555/01 Revised June 2023
Abbreviated New Drug Application
FLECAINIDE ACETATE- FLECAINIDE ACETATE TABLET HIKMA PHARMACEUTICALS USA INC. ---------- FLECAINIDE ACETATE TABLETS, USP RX ONLY DESCRIPTION Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. Flecainide acetate 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, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. CLINICAL PHARMACOLOGY Flecainide 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 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. Sinus node recovery times (corrected) following pacing and spontaneous cycle lengths a are somewhat increased. This latter effect may become significant in patients with sinus node dysfunction. (See WARNINGS.) Flecainide 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 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 appears that plasma level Прочитать полный документ