FLECAINIDE ACETATE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Amneal Pharmaceuticals of New York LLC

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 benefits of treatment outweigh the risks. Flecainide should not be used in patients with recent myocardial infarction (see Boxed WARNINGS ). Use of flecainide 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 favorably affects survival or the incidence of sudden death. Flecainide is contraindicated in patients with preexisting 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 is also contraindicated in the presence of cardiogenic shock or known hypersensitivity to the drug.

Produkto santrauka:

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. Bottles of 100:                                    NDC 53746-641-01 Bottles of 1000:                                  NDC 53746-641-10 100 mg: White, round tablets debossed with “AN” above “642” with a single-line bisect separating them on one side and plain on other side. Bottles of 100:                                    NDC 53746-642-01 Bottles of 1000:                                  NDC 53746-642-10 150 mg: White, oval tablets debossed with “AN”, “643” with a single-line bisect separating them on one side and plain on other side. Bottles of 100:                                    NDC 53746-643-01 Bottles of 1000:                                  NDC 53746-643-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store in a tight, light-resistant container. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382220, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 09-2017-02

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

FLECAINIDE ACETATE- FLECAINIDE ACETATE TABLET
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
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FLECAINIDE ACETATE TABLETS, USP
(50 MG, 100 MG AND 150 MG)
RX ONLY
DESCRIPTION
Flecainide acetate is 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.
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
17
20 6
2
3
2
4
2
a
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 stimulati