Country: Canada
Language: English
Source: Health Canada
AZILSARTAN MEDOXOMIL (AZILSARTAN MEDOXOMIL POTASSIUM); CHLORTHALIDONE
BAUSCH HEALTH, CANADA INC.
C09DA09
AZILSARTANT MEDOXIMIL AND DIURETICS
40MG; 12.5MG
TABLET
AZILSARTAN MEDOXOMIL (AZILSARTAN MEDOXOMIL POTASSIUM) 40MG; CHLORTHALIDONE 12.5MG
ORAL
15G/50G
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0253470002; AHFS:
APPROVED
2012-12-03
_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 Read the complete document