PRZ-OLMESARTAN/HCTZ TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE

제공처:

PHARMARIS CANADA INC

ATC 코드:

C09DA08

INN (국제 이름):

OLMESARTAN MEDOXOMIL AND DIURETICS

복용량:

40MG; 25MG

약제 형태:

TABLET

구성:

OLMESARTAN MEDOXOMIL 40MG; HYDROCHLOROTHIAZIDE 25MG

관리 경로:

ORAL

패키지 단위:

15G/50G

처방전 유형:

Prescription

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2022-04-08

제품 특성 요약

Page 1 of 40
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRZ-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
PHARMARIS CANADA INC.
8310-130 Street, Suite 102,
Surrey, British Columbia,
Canada V3W 8J9
Date of Initial Authorization:
April 06, 2022
Submission Control No: 228559
Page 2 of 40
RECENT MAJOR LABEL CHANGES
None at the time of authorization.
TABLE OF CONTENTS
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.................................................... 4
4
DOSAGE AND ADMINISTRATION
............................................................................
5
4.1
Dosing
Considerations.....................................................................................
5
4.2
Recommended Dose and Dosage Adjustment Replacement Therapy
............. 5
4.3
Reconstitution
..................................................................................................
7
4.4
Administration
..................................................................................................
7
4.5
Missed Dose
....................................................................................................
7
5
OVERDOSAGE
...........................................................................................................
7
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
.....