FLECAINIDE ACETATE- flecainide acetate tablet tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

KAISER FOUNDATION HOSPITALS

INN (International Name):

FLECAINIDE ACETATE

Sammensetning:

FLECAINIDE ACETATE 100 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of Flecainide Acetate

Produkt oppsummering:

Flecainide Acetate Tablets USP are available as: 100 mg: White to off-white, oval, flat-faced, beveled-edge, scored tablet. One side of the tablet is unscored and debossed with ‘ANI’. The other side of the tablet is scored and debossed ‘381’ on one side of the score and ‘100’ on the other. They are available in bottles of 2400 tablets. (NDC 0179-0231-88). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 9786 Rev 12/15 Repackaged by: KAISER FOUNDATION HOSPITALS Livermore, CA 94551

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

FLECAINIDE ACETATE- FLECAINIDE ACETATE TABLET TABLET
KAISER FOUNDATION HOSPITALS
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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-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 the following inactive
ingredients: colloidal silicon
dioxide, croscarmellose sodium, magnesium stearate, microcrystalline
cellulose, pregelatinized starch
and sodium stearyl fumarate.
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.
ELECTROPHYS IOLOGY
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 lengths are somewhat
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. Bas