País: Canadá
Idioma: inglés
Fuente: Health Canada
OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
APOTEX INC
C09DA08
OLMESARTAN MEDOXOMIL AND DIURETICS
40MG; 25MG
TABLET
OLMESARTAN MEDOXOMIL 40MG; HYDROCHLOROTHIAZIDE 25MG
ORAL
30/100/500
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0252502003; AHFS:
APPROVED
2017-05-01
_APO-OLMESARTAN/HCTZ (Olmesartan medoxomil and Hydrochlorothiazide Tablets) _ _Page 1 of 49 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-OLMESARTAN/HCTZ Olmesartan Medoxomil and Hydrochlorothiazide Tablets Tablets, 20 mg / 12.5 mg, 40 mg / 12.5 mg and 40 mg / 25 mg, Oral Angiotensin II AT 1 Receptor Blocker – Diuretic APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Initial Authorization: MAY 01, 2017 Date of Revision: JAN 12, 2023 Submission Control Number: 266735 _APO-OLMESARTAN/HCTZ (Olmesartan medoxomil and Hydrochlorothiazide Tablets) _ _Page 2 of 49 _ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS, Pregnancy and Breastfeeding 01/2023 7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.1 Pregnant Women 01/2023 7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis, Non- Melanoma Skin Cancer 02/2020 7 WARNINGS AND PRECUATIONS, Sensitivity/Resistance, Photosensitivity 02/2020 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 ..................................................................... 5 1 INDICATIONS................................................................................................................... 5 1.1 Pediatrics ............................................................................................................. 5 1.2 Geriatrics.............................................................................................................. 5 2 CONTRAINDICATIONS ..................................................................................................... 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................. 6 4 DOSAGE AND ADMIN Leer el documento completo