FLECAINIDE ACETATE- flecainide acetate tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

Flecainide Acetate (UNII: M8U465Q1WQ) (FLECAINIDE - UNII:K94FTS1806)

Доступна з:

County Line Pharmaceuticals, LLC

ІПН (Міжнародна Ім'я):

Flecainide Acetate

Склад:

Flecainide Acetate 50 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

In patients without structural heart disease, flecainide acetate tablets is 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 are also indicated for the prevention of - documented ventricular arrhythmias, such as sustained ventricular achycardia (sustained VT), that in the judgment of the physician are life-threatening. Use of flecainide acetate tablets for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate tablets 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 shou

Огляд продуктів:

Flecainide acetate tablets, 50 mg are white, round tablet, with CL 56 on one side and 50 on the other side is available in: Bottles of 100 – NDC #43199-056-01 Flecainide acetate tablets, 100 mg are white, round, scored tablet, with CL 57 on one side and 100 on the other side is available in: Bottles of 100 – NDC #43199-057-01 Flecainide acetate tablets, 150 mg are white, oval, scored tablet, with CL 58 on one side and 150 on the other side is available in: Bottles of 100 – NDC #43199-058-01 Store at controlled room temperature 15°-30°C (59°-86°F) in a tight, light-resistant container.

Статус Авторизація:

New Drug Application

Характеристики продукта

FLECAINIDE ACETATE- FLECAINIDE ACETATE TABLET
COUNTY LINE PHARMACEUTICALS, LLC
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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-piperidinyl-methyl)-2,5-bis
(2,2,2-trifluoroethoxy)-monoacetate.
The structural formula is given below.
Flecainide acetate is a white crystalline substance with a pKa of 9.3.
It has an aqueous solubility of 48.4
mg/mL at 37°C.
Flecainide acetate tablets also contain: croscarmellose sodium,
hydrogenated vegetable oil, magnesium
stearate, microcrystalline cellulose and starch.
CLINICAL PHARMACOLOGY
Flecainide acetate tablets have 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.
ELECTROPHYS IOLOGY
In man, flecainide acetate tablets produce 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.)
Flecainide acetate tablets cause 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 tablets have
been successful 30-40% of the time in
fully suppressing the inducibility of arrhythmias by programmed
electrical stimulation. Based on PVC
suppression, it appears that plasma levels of 0.2 to 1.0 μg/mL may be
needed t