PMS-SOTALOL - 240 MG TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

SOTALOL HYDROCHLORIDE

Mevcut itibaren:

PHARMASCIENCE INC

ATC kodu:

C07AA07

INN (International Adı):

SOTALOL

Doz:

240MG

Farmasötik formu:

TABLET

Kompozisyon:

SOTALOL HYDROCHLORIDE 240MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

BETA-ADRENERGIC BLOCKING AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0113778004; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

1998-07-06

Ürün özellikleri

_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