EDARBYCLOR TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

AZILSARTAN MEDOXOMIL (AZILSARTAN MEDOXOMIL POTASSIUM); CHLORTHALIDONE

Disponible depuis:

BAUSCH HEALTH, CANADA INC.

Code ATC:

C09DA09

DCI (Dénomination commune internationale):

AZILSARTANT MEDOXIMIL AND DIURETICS

Dosage:

40MG; 12.5MG

forme pharmaceutique:

TABLET

Composition:

AZILSARTAN MEDOXOMIL (AZILSARTAN MEDOXOMIL POTASSIUM) 40MG; CHLORTHALIDONE 12.5MG

Mode d'administration:

ORAL

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Descriptif du produit:

Active ingredient group (AIG) number: 0253470002; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2012-12-03

Résumé des caractéristiques du produit

_Pr_
_EDARBYCLOR_
_®_
_ Product Monograph Page 1 of 48_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
EDARBYCLOR
®
Azilsartan Medoxomil and Chlorthalidone Tablets
(as azilsartan medoxomil potassium and chlorthalidone)
40 mg/12.5 mg, 80 mg/12.5 mg and 40 mg/25 mg, Oral
Angiotensin II AT1 Receptor Blocker and Thiazide-like Diuretic
Bausch Health, Canada Inc.
2150 St-Elzear Blvd. West
Laval, Quebec
H7L 4A8
Date of Initial Authorization:
December 3, 2012
Date of Revision:
November 10, 2023
Submission Control Number: 276262
_ _
_Pr_
_EDARBYCLOR_
_®_
_ Product Monograph Page 2 of 48_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
11/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
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
......................................................... 5
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustmen