AG-FLECAINIDE TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

FLECAINIDE ACETATE

Beschikbaar vanaf:

ANGITA PHARMA INC.

ATC-code:

C01BC04

INN (Algemene Internationale Benaming):

FLECAINIDE

Dosering:

100MG

farmaceutische vorm:

TABLET

Samenstelling:

FLECAINIDE ACETATE 100MG

Toedieningsweg:

ORAL

Eenheden in pakket:

15G/50G

Prescription-type:

Prescription

Therapeutisch gebied:

CLASS IC ANTIARRYTHMICS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2021-06-03

Productkenmerken

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