AURO-FLECAINIDE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

FLECAINIDE ACETATE

Saatavilla:

AURO PHARMA INC

ATC-koodi:

C01BC04

INN (Kansainvälinen yleisnimi):

FLECAINIDE

Annos:

50MG

Lääkemuoto:

TABLET

Koostumus:

FLECAINIDE ACETATE 50MG

Antoreitti:

ORAL

Kpl paketissa:

20/100/500/1000

Prescription tyyppi:

Prescription

Terapeuttinen alue:

CLASS IC ANTIARRYTHMICS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2016-12-20

Valmisteyhteenveto

PRODUCT MONOGRAPH
AURO-FLECAINIDE
FLECAINIDE TABLETS BP
50 MG AND 100 MG (AS FLECAINIDE ACETATE)
ANTIARRHYTHMIC AGENT
AURO PHARMA INC.
DATE OF PREPARATION
3700 Steeles Avenue West, Suite # 402
December 16, 2016
Woodbridge, Ontario, L4L 8K8,
Canada.
SUBMISSION CONTROL NUMBER: 192770
PRODUCT MONOGRAPH
AURO-FLECAINIDE
Flecainide Tablets BP
50 mg and 100 mg (as Flecainide acetate)
Antiarrhythmic Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Flecainide belongs to the membrane stabilizing group of antiarrhythmic
agents; it has
electrophysiologic effects characteristics of the 1C class of the
modified Vaughan-Williams
classification. It also possesses local anesthetic properties.
In single cell preparations from canine cardiac tissues (Purkinje
fibers), flecainide 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 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 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 flecain