AG-FLECAINIDE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

FLECAINIDE ACETATE

Disponible desde:

ANGITA PHARMA INC.

Código ATC:

C01BC04

Designación común internacional (DCI):

FLECAINIDE

Dosis:

100MG

formulario farmacéutico:

TABLET

Composición:

FLECAINIDE ACETATE 100MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

CLASS IC ANTIARRYTHMICS

Resumen del producto:

Active ingredient group (AIG) number: 0116696001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2021-06-03

Ficha técnica

Page 1 of 26
PRODUCT MONOGRAPH
PR
AG-FLECAINIDE
FLECAINIDE ACETATE TABLETS, USP
50 MG AND 100 MG
ANTIARRHYTHMIC AGENT
ANGITA PHARMA INC.
1310, RUE NOBEL
BOUCHERVILLE, QUEBEC
J4B 5H3
CONTROL NO. 251259
DATE OF
REVISION:
MAY
28
, 2021
Page 2 of 26
PR
AG-Flecainide
Flecainide Acetate Tablets, USP
50 mg and 100 mg
THERAPEUTIC CLASSIFICATION
Antiarrhythmic agent
ACTIONS AND CLINICAL PHARMACOLOGY
Flecainide acetate belongs to the membrane stabilizing group of
antiarrhythmic agents: it has
electrophysiologic effects characteristic of the 1C class of the
modified Vaughn-Williams
classification. It also possesses local anesthetic properties.
In single cell preparations from canine cardiac tissues (Purkinje
fibers) flecainide acetate
decreased the rate of rise (V
max
, Phase 0) of the action potential without greatly affecting its
duration; the duration of the effective refractory period was
lengthened and a small change was
observed in the slope of Phase 4 depolarization. In ventricular
muscle, some lengthening of the
action potential duration has been observed.
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). In patients with
accessory AV connections, flecainide acetate has been shown to depress
both anterograde and
retrograde conduction over the bypass tract.
HEMODYNAMICS: Decreases in ejection fraction, consistent with a
negative inotropic effect, have
been observed after a single administration of 200 to 250 mg of
flecainide acetate