APO-OLMESARTAN/HCTZ TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE

Sẵn có từ:

APOTEX INC

Mã ATC:

C09DA08

INN (Tên quốc tế):

OLMESARTAN MEDOXOMIL AND DIURETICS

Liều dùng:

40MG; 25MG

Dạng dược phẩm:

TABLET

Thành phần:

OLMESARTAN MEDOXOMIL 40MG; HYDROCHLOROTHIAZIDE 25MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/100/500

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0252502003; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2017-05-01

Đặc tính sản phẩm

_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