Country: Canada
Language: English
Source: Health Canada
PROPAFENONE HYDROCHLORIDE
NU-PHARM INC
C01BC03
PROPAFENONE
150MG
TABLET
PROPAFENONE HYDROCHLORIDE 150MG
ORAL
100
Prescription
CLASS IC ANTIARRYTHMICS
Active ingredient group (AIG) number: 0116258001; AHFS:
CANCELLED (UNRETURNED ANNUAL)
2018-03-28
PRODUCT MONOGRAPH NU-PROPAFENONE PROPAFENONE HYDROCHLORIDE TABLETS 150 MG ANTIARRHYTHMIC AGENT NU-PHARM INC. DATE OF PREPARATION: 50 MURAL STREET, UNITS 1&2 February 11, 2003 RICHMOND HILL, ONTARIO L4B 1E4 _Control # 089683_ 1 PRODUCT MONOGRAPH NU-PROPAFENONE Propafenone Hydrochloride Tablets 150 mg THERAPEUTIC CLASSIFICATION Antiarrhythmic Agent A CTIONS AND CLINICAL PHARMACOLOGY Mechanism of Action Propafenone is an antiarrhythmic agent which possesses class Ic properties in the modified electrophysiological classification of Vaughan-Williams. It has a direct stabilizing action on myocardial cell membranes. The electrophysiological effect of propafenone manifests itself as a reduction of the upstroke velocity (Phase 0) of the monophasic action potential, while phase 4 spontaneous automaticity is depressed. Diastolic excitability threshold is increased and effective refractory period prolonged. In Purkinje fibers, and to a lesser extent myocardial fibers, propafenone reduces the fast inward sodium current. In addition to a local anesthetic effect, approximately equal to procaine, propafenone has weak beta-blocking activity. Clinical trials employing isoproterenol challenge and exercise testing suggest that the affinity of propafenone for beta-adrenergic receptors, as calculated from dose ratios and drug concentrations, is about 1/40 that of propranolol. Propafenone also inhibits the slow calcium influx at high concentrations; however, this action is weak (approximately 1/100 of verapamil) and does not contribute to its antiarrhythmic effect. 2 Electrophysiology Electrophysiology studies have shown that propafenone prolongs atrioventricular conduction and in some instances significantly lengthens sinus nodal recovery times with a non-significant effect on sinus cycle length. AV nodal conduction time (AH interval) as well as His-Purkinje conduction time (HV interval) are prolonged. Propafenone increases atrial, AV nodal and ventricular effective refractory periods. Propafenone causes a dose-dependent increase in t Read the complete document