País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
FLECAINIDE ACETATE (UNII: M8U465Q1WQ) (FLECAINIDE - UNII:K94FTS1806)
Golden State Medical Supply, Inc.
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 is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of Flecai
Flecainide Acetate Tablets USP are available as: 50 mg: White to off-white, round, flat-faced, beveled-edge, unscored tablet debossed with ‘ANI’ on one side and ‘380’ on the other side. They are available in bottles of 100 tablets. (NDC 51407-018-01). 100 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 ‘381’ on one side of the score and ‘100’ on the other. They are available in bottles of 60 tablets (NDC 51407-019-60) and bottles of 100 tablets. (NDC 51407-019-01). 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 51407-020-01). 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). Manufactured by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 9786 Rev 12/15 Marketed by: GSMS, Inc. Camarillo, CA USA 93012
Abbreviated New Drug Application
FLECAINIDE ACETATE- FLECAINIDE ACETATE TABLET TABLET GOLDEN STATE MEDICAL SUPPLY, INC. ---------- 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 stimulati Leer el documento completo