APO-IRBESARTAN TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

IRBESARTAN

MAH:

APOTEX INC

ATC_code:

C09CA04

INN:

IRBESARTAN

dosage:

150MG

pharmaceutical_form:

TABLET

composition:

IRBESARTAN 150MG

administration_route:

ORAL

units_in_package:

100/500

prescription_type:

Prescription

therapeutic_area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0131700002; AHFS:

authorization_status:

APPROVED

authorization_date:

2012-05-25

SPC

_Product Monograph Master Template _
_APO-IRBESARTAN _
Page 1 of 35
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-IRBESARTAN
Irbesartan tablets
Tablets, 75 mg, 150 mg and 300 mg, Oral
USP
Angiotensin II AT
1
Receptor Blocker
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
Date of Initial Authorization:
May 24, 2012
Date of Revision:
August 12, 2021
Submission Control Number: 251515
_Product Monograph Master Template _
_APO-IRBESARTAN _
Page 2 of 35
RECENT MAJOR LABEL CHANGES
7. WARNINGS AND PRECAUTIONS
08/2021
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
..............................................................................................
2
TABLE 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 .................................................................. 4
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1 Dosing Considerations
.................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment Essential Hypertension
................................ 5
4.4 Administration
...........................................................................................................
6
4.5 Missed Dose
........