Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
FLECAINIDE ACETATE (UNII: M8U465Q1WQ) (FLECAINIDE - UNII:K94FTS1806)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
In patients without structural heart disease, Flecainide Acetate Tablets USP are indicated for the prevention of: Flecainide Acetate Tablets USP are also indicated for the prevention of: 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 cont
Flecainide Acetate Tablets USP are available as: 150 mg: White to off-white, oval, flat-faced, beveled-edge, scored tablet. One side of the tablet is unscored and debossed with ‘ANI’. The other side of the tablet is scored and debossed ‘382’ on one side of the score and ‘150’ on the other. They are available in bottles of 100 tablets. (NDC 63629-1981-1). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Abbreviated New Drug Application
FLECAINIDE ACETATE- FLECAINIDE ACETATE TABLET TABLET BRYANT RANCH PREPACK ---------- 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-piperidinylmethyl)-2,5-bis (2,2,2-trifluoroethoxy)- monoacetate. The structural formula is given below. Flecainide acetate is a white crystalline substance 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 the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium stearyl fumarate. 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. 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). a 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 Baca dokumen lengkap