CO GLIMEPIRIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-12-2005
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Active ingredient:
GLIMEPIRIDE
Available from:
COBALT PHARMACEUTICALS COMPANY
ATC code:
A10BB12
INN (International Name):
GLIMEPIRIDE
Dosage:
1MG
Pharmaceutical form:
TABLET
Composition:
GLIMEPIRIDE 1MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
SULFONYLUREAS
Product summary:
Active ingredient group (AIG) number: 0146247001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2012-08-02
Summary of Product characteristics
Page 1 of 43
PRODUCT MONOGRAPH
PR
_CO GLIMEPIRIDE_
glimepiride
Tablets 1, 2, 3, and 4 mg
Oral Hypoglycemic (Sulfonylurea)
Cobalt Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, Ontario L5N 2B8
Date of Preparation:
December 22, 2005
Submission Control No: 092544
Page 2 of 43
Table of Contents
PART I: HEALTH PROFESSIONAL INFORMATION
...........................................................3
SUMMARY PRODUCT
INFORMATION....................................................................3
INDICATIONS AND CLINICAL USE
..........................................................................3
CONTRAINDICATIONS
...............................................................................................
3
WARNINGS AND PRECAUTIONS
..............................................................................4
ADVERSE
REACTIONS................................................................................................7
DRUG
INTERACTIONS................................................................................................9
DOSAGE AND ADMINISTRATION
..........................................................................11
OVERDOSAGE
............................................................................................................
13
ACTION AND CLINICAL
PHARMACOLOGY.........................................................14
STORAGE AND STABILITY
......................................................................................17
DOSAGE FORMS, COMPOSITION AND
PACKAGING..........................................17
PART II: SCIENTIFIC INFORMATION
................................................................................18
PHARMACEUTICAL
INFORMATION......................................................................18
CLINICAL
TRIALS......................................................................................................19
DETAILED PHARMACOLOGY
.................................................................................25
TOXICOLOGY
.................................
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