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:

Physicians Total Care, 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 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,

Product summary:

Flecainide Acetate Tablets, USP are supplied as white, biconvex tablets for the 50 mg and 100 mg strengths and white, capsule shaped tablets for the 150 mg strength. The 50 mg tablets are plain on one side and debossed with “54/024” on the other side. The 100 mg tablets are scored on one side and debossed with “54/070” on the other side. The 150 mg tablets are scored on one side and debossed with “54/150” on the other side. Store at controlled room temperature 15° to 30°C (59° to 86°F) (see USP) in a tight, light-resistant container. 10001280/04 Revised September 2007 © RLI, 2007 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLECAINIDE ACETATE - FLECAINIDE ACETATE TABLET
PHYSICIANS TOTAL CARE, INC.
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FLECAINIDE ACETATE TABLETS, USP
RX ONLY
DESCRIPTION
Flecainide Acetate Tablets, USP are an antiarrhythmic drug available
in tablets of 50, 100 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: hydrogenated cottonseed
oil, magnesium stearate,
microcrystalline cellulose, modified cellulose gum, and pregelatinized
starch.
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.
ELECTROPHYS IOLOGY
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, it appears
that plasma levels of 0.2 to 1 mcg/mL may be needed