MAR-FLECAINIDE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLECAINIDE ACETATE

Available from:

MARCAN PHARMACEUTICALS INC

ATC code:

C01BC04

INN (International Name):

FLECAINIDE

Dosage:

100MG

Pharmaceutical form:

TABLET

Composition:

FLECAINIDE ACETATE 100MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

CLASS IC ANTIARRYTHMICS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2018-05-28

Summary of Product characteristics

Page 1 of 28
PRODUCT
MONOG
RA
PH
PR MAR- FLECAINIDE
FLECAINIDE ACETATE TABLETS
50 MG AND 100 MG
MANUFACTURER’S STANDARD
ANTIARRHYTHMIC A
GE
NT
MARCAN PHARMACEUTICALS INC.
DATE OF REVISION:
77 AURIGA DRIVE, UNIT #4
May 24, 2018
OTTAWA, ONTARIO, K2E7Z7
CANADA
CONTROL NUMBER
: 209901
Page 2 of 28
PR MAR- FLECAINIDE
Pr
Flecainide Acetate Tablets
50 mg and 100
mg
THERAPEUTIC
CL
ASSIFI
C
ATION
Antiarrhythmic agent
ACTIONS AND CLINICAL
P
HARMAC
OLOG
Y
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 sin