Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
FLECAINIDE ACETATE
NORA PHARMA INC
C01BC04
FLECAINIDE
100MG
TABLET
FLECAINIDE ACETATE 100MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0116696001; AHFS:
APPROVED
2022-08-23
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 Prečítajte si celý dokument