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:

Hikma Pharmaceuticals USA 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 is indicated for the prevention of: Flecainide acetate is also indicated for the prevention of: Use of flecainide acetate 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, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. Flecainide acetate should not be used in patients with recent myocardial infarction. (See Boxed WARNINGS.) Use of flecainide acetate 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 favorably affects survival or t

Product summary:

Flecainide Acetate Tablets, USP 50 mg tablet is supplied as a white, round, biconvex tablet with product identification “54 024” debossed on one side and plain on the other side. NDC 0054-0010-21: Bottle of 60 Tablets NDC 0054-0010-25: Bottle of 100 Tablets NDC 0054-0010-20: 10x10 Unit-Dose Tablets 100 mg tablet is supplied as a white, round, biconvex tablet with product identification “54 070” debossed on one side and a deep bisect on the other. NDC 0054-0011-21: Bottle of 60 Tablets NDC 0054-0011-25: Bottle of 100 Tablets NDC 0054-0011-20: 10x10 Unit-Dose Tablets 150 mg tablet is supplied as a white, capsule shaped, biconvex tablet with product identification “54 150” debossed on one side and a score on the other. NDC 0054-0012-21: Bottle of 60 Tablets NDC 0054-0012-25: Bottle of 100 Tablets NDC 0054-0012-20: 10x10 Unit-Dose Tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000555/01 Revised June 2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLECAINIDE ACETATE- FLECAINIDE ACETATE TABLET
HIKMA PHARMACEUTICALS USA INC.
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FLECAINIDE ACETATE TABLETS, USP
RX ONLY
DESCRIPTION
Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing
50 mg, 100 mg or
150 mg of flecainide acetate, USP for oral administration.
Flecainide acetate is
N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide
monoacetate. The structural formula is given below.
Flecainide acetate 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, magnesium stearate, microcrystalline cellulose, 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.
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
a
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 level