IRBESARTAN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IRBESARTAN

Available from:

SIVEM PHARMACEUTICALS ULC

ATC code:

C09CA04

INN (International Name):

IRBESARTAN

Dosage:

300MG

Pharmaceutical form:

TABLET

Composition:

IRBESARTAN 300MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0131700003; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-05-25

Summary of Product characteristics

_IRBESARTAN _
_Page 1 of 37_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
IRBESARTAN
Irbesartan tablets
Tablets, 75 mg, 150 mg and 300 mg, Oral
USP
Angiotensin II AT
1
Receptor Blocker
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Date of Initial Authorization
MAY 25, 2012
Date of revision
JAN 02, 2024
Submission Control No.: 281898
_IRBESARTAN _
_Page 2 of 37_
_ _
RECENT MAJOR LABEL CHANGES
7. WARNINGS AND PRECAUTIONS
01/2024
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES………………………………………………………………………….…...............2
TABLES OF
CONTENTS………………...……………………………………………………………………….…...............2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration
..........................................................................................................
6
4.5
Missed Dose
...............................................