CO SOTALOL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SOTALOL HYDROCHLORIDE

Available from:

COBALT PHARMACEUTICALS COMPANY

ATC code:

C07AA07

INN (International Name):

SOTALOL

Dosage:

80MG

Pharmaceutical form:

TABLET

Composition:

SOTALOL HYDROCHLORIDE 80MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC BLOCKING AGENTS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-05-07

Summary of Product characteristics

_ _
_CO SOTALOL Product Monograph – June 13, 2006 _
_Page 1 of 30_
PRODUCT MONOGRAPH
Pr
_CO_ SOTALOL
Sotalol Hydrochloride
80 mg and 160 mg
BP
Anti-arrhythmic
Cobalt Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, Ontario
L5N 2B8
Date of Preparation:
August 19, 2005
Date of Revision:
June 20, 2006
Submission Control No: 106618
_ _
_CO SOTALOL Product Monograph – June 13, 2006 _
_Page 2 of 30_
Table of Contents
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS..................................................................................................10
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND
ADMINISTRATION..............................................................................14
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................16
STORAGE AND
STABILITY..........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................20
PHARMACEUTICAL
INFORMATION..........................................................................20
CLINICAL
TRIALS............................................................................................