APO-OLMESARTAN/HCTZ TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE

から入手可能:

APOTEX INC

ATCコード:

C09DA08

INN（国際名）:

OLMESARTAN MEDOXOMIL AND DIURETICS

投薬量:

40MG; 25MG

医薬品形態:

TABLET

構図:

OLMESARTAN MEDOXOMIL 40MG; HYDROCHLOROTHIAZIDE 25MG

投与経路:

ORAL

パッケージ内のユニット:

30/100/500

処方タイプ:

Prescription

治療領域:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2017-05-01

製品の特徴

_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