Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
SOTALOL HYDROCHLORIDE
PHARMASCIENCE INC
C07AA07
SOTALOL
160MG
TABLET
SOTALOL HYDROCHLORIDE 160MG
ORAL
100/500
Prescription
BETA-ADRENERGIC BLOCKING AGENTS
Active ingredient group (AIG) number: 0113778001; AHFS:
APPROVED
1998-07-06
_O _ PRODUCT MONOGRAPH PMS-SOTALOL (Sotalol Hydrochloride Tablets BP) 80 mg, 160 mg and 240 mg ANTIARRHYTHMIC Pharmascience Inc. Date of Preparation: 6111 Royalmount June 30, 1998 Montreal, Canada Control No. 051859 H4P 2T4 Date of Revision: November 27, 2002 Control No: 079637 • PRODUCT MONOGRAPH NAME OF DRUG PMS-SOTALOL (Sotalol Hydrochloride Tablets BP) 80 mg, 160 mg and 240 mg THERAPEUTIC CLASSIFICATION Antiarrhythmic ACTION AND CLINICAL PHARMACOLOGY pms-SOTALOL(sotalolhydrochloride)hasbothbeta-adrenoreceptoiblocking(VaughanWilliams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmicproperties.pms-SOTALOLisaracemicmixtureofd-andl-sotalol. Both i somers have similar class III antiarrhythmic effects, while the 1-isomer is responsible for virtually all of thebeta-blockingactivity. Sotalol isnon-cardioselectiveand isnot associated with partial agonist or membrane stabilizing activity. Whereas significant beta-blockade may occur at oral doses as low as 25 mg, Class III effects are seen at daily doses of 160 mg and above. The antiarrhythmic activity of sotalol appears to be primarily due to the drug's Class III property, based on animal models. Pharmacologically, in addition to its antiarrhythmic properties, pms-SOTALOL also hi antihypertensive and anti-anginal properties. ELECTROPHYSIOLOGY: in the isolated myocyte, as well as in isolated tissue preparations of ventricular and atrial muscle (class III activity). In intact animals it slows heart rate, decreases AV nodal conduction and increases the refractory periods of atrial and ventricular muscle and conduction tissue. Inman,theclassII(beta-blockade)electrophysiologicaleffectsofpms-SOTALOLaremanifested by increased sinus cycle length, decreased AV nodal conduction and increased AV noda refractoriness. The class III electrophysiological effects in man include prolongation ofthe atrial andventricularmonophasicactionpotentials,andeffectiverefractoryperiodprolongationofatrial muscle, ventricular muscle, and atrio Přečtěte si celý dokument