AG-FLECAINIDE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

FLECAINIDE ACETATE

Pieejams no:

ANGITA PHARMA INC.

ATĶ kods:

C01BC04

SNN (starptautisko nepatentēto nosaukumu):

FLECAINIDE

Deva:

100MG

Zāļu forma:

TABLET

Kompozīcija:

FLECAINIDE ACETATE 100MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Ārstniecības joma:

CLASS IC ANTIARRYTHMICS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2021-06-03

Produkta apraksts

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