FLECAINIDE ACETATE- flecainide acetate tablet tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

FLECAINIDE ACETATE (UNII: M8U465Q1WQ) (FLECAINIDE - UNII:K94FTS1806)

Disponível em:

ANI Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

FLECAINIDE ACETATE

Composição:

FLECAINIDE ACETATE 50 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

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 62559-380-01). 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 100 tablets. (NDC 62559-381-01). 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 62559-382-01). 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

Status de autorização:

Abbreviated New Drug Application

Características técnicas

FLECAINIDE ACETATE- FLECAINIDE ACETATE TABLET TABLET
ANI PHARMACEUTICALS, INC.
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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. Base