FLECAINIDE ACETATE- flecainide acetate tablet tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Bryant Ranch Prepack

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

Flecainide Acetate Tablets USP are available as: 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 63629-1945-1). 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

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

FLECAINIDE ACETATE- FLECAINIDE ACETATE TABLET TABLET
BRYANT RANCH PREPACK
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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. Based on