NRA-FLECAINIDE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

FLECAINIDE ACETATE

MAH:

NORA PHARMA INC

ATC_code:

C01BC04

INN:

FLECAINIDE

dosage:

50MG

pharmaceutical_form:

TABLET

composition:

FLECAINIDE ACETATE 50MG

administration_route:

ORAL

units_in_package:

15G/50G

prescription_type:

Prescription

leaflet_short:

Active ingredient group (AIG) number: 0116696004; AHFS:

authorization_status:

APPROVED

authorization_date:

2022-08-23

SPC

Page 1 of 28
PRODUCT
MONOG
RA
PH
PR NRA-FLECAINIDE
FLECAINIDE ACETATE TABLETS
50 MG AND 100 MG
MANUFACTURER’S STANDARD
ANTIARRHYTHMIC A
GE
NT
Date of
Preparation:
August
22, 2022
Nora Pharma Inc.
1565 Lionel-Boulet Blvd.
Varennes, Quebec
J3X 1P7
CONTROL
NUMBER
: 266421
Page 2 of 28
PR
NRA-FLECAINIDE
Flecainide Acetate Tablets
50 mg and 100
mg
THERAPEUTIC CLASSIFICATION
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 single administration