FLECAINIDE ACETATE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Bryant Ranch Prepack

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 proarr

Tuoteyhteenveto:

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. NDC: 63629-7979-3: 90 Tablets in a BOTTLE NDC: 63629-7979-1: 30 Tablets in a BOTTLE NDC: 63629-7979-2: 60 Tablets in a BOTTLE NDC: 63629-7979-4: 10 Tablets in a BOTTLE NDC: 63629-7979-5: 180 Tablets in a BOTTLE Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature] in a tight, light-resistant container. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

FLECAINIDE ACETATE- FLECAINIDE ACETATE TABLET
BRYANT RANCH PREPACK
----------
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
appears th