APO-FLECAINIDE TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

FLECAINIDE ACETATE

Inapatikana kutoka:

APOTEX INC

ATC kanuni:

C01BC04

INN (Jina la Kimataifa):

FLECAINIDE

Kipimo:

50MG

Dawa fomu:

TABLET

Tungo:

FLECAINIDE ACETATE 50MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

100

Dawa ya aina:

Prescription

Eneo la matibabu:

CLASS IC ANTIARRYTHMICS

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2010-06-02

Tabia za bidhaa

Page
1
of
26
PRODUCT MONOGRAPH
PR
APO-FLECAINIDE
FLECAINIDE ACETATE TABLETS USP
50 MG AND 100 MG
ANTIARRHYTHMIC AGENT
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
NOVEMBER 7, 2017
TORONTO, ONTARIO
CANADA M9L 1T9
CONTROL NO. 209512
Page
2
of
26
PR
APO-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 acet