APO-IRBESARTAN/HCTZ TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-09-2021
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Active ingredient:
IRBESARTAN; HYDROCHLOROTHIAZIDE
Available from:
APOTEX INC
ATC code:
C09DA04
INN (International Name):
IRBESARTAN AND DIURETICS
Dosage:
300MG; 12.5MG
Pharmaceutical form:
TABLET
Composition:
IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 12.5MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0240086002; AHFS:
Authorization status:
APPROVED
Authorization date:
2012-06-12
Summary of Product characteristics
Page 1 of 54
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-IRBESARTAN/HCTZ
(Irbesartan and hydrochlorothiazide Tablets USP)
150/12.5 mg, 300/12.5 mg and 300/25 mg, Oral
Angiotensin II AT
1 Receptor
Blocker / Diuretic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
June 12, 2012
Date of Revision:
September 29, 2021
Submission Control No.: 251965
Page 2 of 54
RECENT MAJOR LABEL CHANGES
7. Warnings and Precautions
10/2021
TABLE OF CONTENT
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
................................................................................................................................
6
5
OVERDOSAGE
................................................................................
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