APO-IRBESARTAN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

IRBESARTAN

Disponible depuis:

APOTEX INC

Code ATC:

C09CA04

DCI (Dénomination commune internationale):

IRBESARTAN

Dosage:

150MG

forme pharmaceutique:

TABLET

Composition:

IRBESARTAN 150MG

Mode d'administration:

ORAL

Unités en paquet:

100/500

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2012-05-25

Résumé des caractéristiques du produit

_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
........