PMS-SOTALOL - 80 MG TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SOTALOL HYDROCHLORIDE

Available from:

PHARMASCIENCE INC

ATC code:

C07AA07

INN (International Name):

SOTALOL

Dosage:

80MG

Pharmaceutical form:

TABLET

Composition:

SOTALOL HYDROCHLORIDE 80MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0113778002; AHFS:

Authorization status:

APPROVED

Authorization date:

1998-07-06

Summary of Product characteristics

_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