TEVETEN TABLETS 300 MG

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

EPROSARTAN (EPROSARTAN MESYLATE)

Available from:

SOLVAY PHARMA INC

ATC code:

C09CA02

INN (International Name):

EPROSARTAN

Dosage:

300MG

Pharmaceutical form:

TABLET

Composition:

EPROSARTAN (EPROSARTAN MESYLATE) 300MG

Administration route:

ORAL

Units in package:

60

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0137701001; AHFS:

Authorization status:

APPROVED

Authorization date:

1999-08-19

Summary of Product characteristics

_ _
_Appendix E - Product Monograph Template – Standard (DRAFT) –
March 29, 2005 _
_Page 1 of 35_
PRODUCT MONOGRAPH
Pr
TEVETEN
®
Eprosartan Mesylate Tablets
(containing 400 mg and 600 mg eprosartan)
Angiotensin II receptor (AT
1
) antagonist
Date of Preparation:
August 20, 1999
Date of Revision:
May 25, 2006
Submission Control No: 099001
_ _
_Appendix E - Product Monograph Template – Standard (DRAFT) –
March 29, 2005 _
_Page 2 of 35_
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....................................................................................................6
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND
ADMINISTRATION..............................................................................12
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND
STABILITY..........................................................................................17
SPECIAL HANDLING INSTRUCTIONS
.......................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................19
PHARMACEUTICAL
INFORMATION....................................