Страна: Канада
Език: английски
Източник: Health Canada
FLECAINIDE ACETATE
SANIS HEALTH INC
C01BC04
FLECAINIDE
50MG
TABLET
FLECAINIDE ACETATE 50MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0116696004; AHFS:
APPROVED
2023-01-30
PRODUCT MONOGRAPH PR FLECAINIDE FLECAINIDE TABLETS BP 50 MG AND 100 MG (AS FLECAINIDE ACETATE) ANTIARRHYTHMIC AGENT Sanis Health Inc. DATE OF PREPARATION 1 President's Choice Circle JAN 30, 2023 Brampton, Ontario L6Y 5S5 SUBMISSION CONTROL NUMBER: 270843 PRODUCT MONOGRAPH Pr 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 flecainide; both increases and decrea Прочетете целия документ