FLECAINIDE ACETATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rising Pharma Holdings, Inc.

INN (International Name):

FLECAINIDE ACETATE

Composition:

FLECAINIDE ACETATE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 are 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 controlled trials that the use of flecainide acetate tablets, USP favorably affects survival or the incidence of sudden death. Flecainide acetate tablets are contraindicated in patients with pre existing second- or third-degree AV block, or with right bundle branch block when associated with a left hemiblock (bifascicular block), unless a pacemaker is present to sustain the cardiac rhythm should complete heart block occur. Flecainide acetate tablets are also contraindicated in the presence of cardiogenic shock or known hypersensitivity to the drug.

Product summary:

Flecainide Acetate Tablets USP, 50 mg are white to off-white, round, biconvex tablets debossed with “CC” on one side and “11” on other side.         Bottles of 100         57237-063-01 Flecainide Acetate Tablets USP, 100 mg are white to off-white, round, biconvex tablets debossed with ‘1’ and ‘2’ separated by deep score line on one side and “CC” on other side.         Bottles of 100         57237-064-01 Flecainide Acetate Tablets USP, 150 mg are white to off-white, oval, biconvex tablets debossed with ‘1’ and ‘3’ separated by deep score line on one side and “CC” on other side.         Bottles of 100         57237-065-01 Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature] in a tight, light-resistant container. Distributed by: Rising Health, LLC Saddle Brook, NJ 07663 Made in India Code: TS/DRUGS/22/2009 Revised: 12/2017

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLECAINIDE ACETATE - FLECAINIDE ACETATE TABLET
RISING PHARMA HOLDINGS, 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-piperidinyl-methyl)-2,5-bis
(2,2,2-trifluoroethoxy)-
monoacetate. The structural formula is given below.
Flecainide acetate USP is a white to slightly off-white, crystalline
powder 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: croscarmellose sodium,
hydrogenated
vegetable oil type 1, magnesium stearate, microcrystalline cellulose,
and pregelatinized
starch.
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
a
lengths are some what increased. This latter effect may become
significant in patients
with sinus node dysfunction. (See WARNINGS.)
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 PVC suppression, it
a