EDARBYCLOR TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AZILSARTAN MEDOXOMIL (AZILSARTAN MEDOXOMIL POTASSIUM); CHLORTHALIDONE

Available from:

BAUSCH HEALTH, CANADA INC.

ATC code:

C09DA09

INN (International Name):

AZILSARTANT MEDOXIMIL AND DIURETICS

Dosage:

40MG; 25MG

Pharmaceutical form:

TABLET

Composition:

AZILSARTAN MEDOXOMIL (AZILSARTAN MEDOXOMIL POTASSIUM) 40MG; CHLORTHALIDONE 25MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0253470003; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-12-03

Summary of Product characteristics

_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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
......................................................... 5
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustmen