FLECAINIDE ACETATE- flecainide acetate tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

American Health Packaging

INN (International Name):

FLECAINIDE ACETATE

Sammensetning:

FLECAINIDE ACETATE 50 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

In patients without structural heart disease, flecainide 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 is 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 for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of flecainide, its use should be reserved for patients in whom, in the opinion of the physician, the bene

Produkt oppsummering:

Flecainide acetate tablets, USP are available as follows: 50 mg White, round tablets debossed with “AN” above “641” on one side and plain on other side. Unit dose packages of 30 (5 x 6) NDC 60687-225-25 100 mg White, round tablets debossed with “AN” above “642” with a single-line bisect separating them on one side and plain on other side. Unit dose packages of 30 (5 x 6) NDC 68084-540-25 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Amneal Pharmaceuticals as follows: (50 mg / 30 UD) NDC 60687-225-25 packaged from NDC 65162-641 (100 mg / 30 UD) NDC 68084-540-25 packaged from NDC 65162-642 Distributed by: American Health Packaging Columbus, OH 43217 8254021/0616OS

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

FLECAINIDE ACETATE- FLECAINIDE ACETATE TABLET
AMERICAN HEALTH PACKAGING
----------
FLECAINIDE ACETATE TABLETS, USP
8254021/0616OS
RX ONLY
DESCRIPTION
Flecainide acetate, USP is an antiarrhythmic drug available in tablets
of 50, 100, or 150 mg for oral
administration.
Flecainide acetate, USP is benzamide,
N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-,
monoacetate. The structural formula is given below.
1. Molecular formula: C
H
F
N
O
•C
H
O
Molecular weight: 474.40
Flecainide acetate, USP 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: croscarmellose sodium,
microcrystalline cellulose and magnesium stearate.
CLINICAL PHARMACOLOGY
Flecainide 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 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.)
Flecainide 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 has been successful 30% to 40% of
the time in fully suppressing the
inducibility of arrhythmias by programmed electrical stimulation.
Based on PVC suppression, i