ALEMBIC-TELMISARTAN/HCTZ TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

HYDROCHLOROTHIAZIDE; TELMISARTAN

제공처:

ALEMBIC PHARMACEUTICALS LIMITED

ATC 코드:

C09DA07

INN (국제 이름):

TELMISARTAN AND DIURETICS

복용량:

12.5MG; 80MG

약제 형태:

TABLET

구성:

HYDROCHLOROTHIAZIDE 12.5MG; TELMISARTAN 80MG

관리 경로:

ORAL

패키지 단위:

(10X10)/30/1000

처방전 유형:

Prescription

치료 영역:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

제품 요약:

Active ingredient group (AIG) number: 0244783001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2018-08-09

제품 특성 요약

_Alembic-Telmisartan/HCTZ Product Monograph _
_Page 1 of 57 _
_ _
PRODUCT MONOGRAPH
PR
ALEMBIC-TELMISARTAN/HCTZ
Telmisartan and Hydrochlorothiazide Tablets, USP
80 mg/12.5 mg
80 mg/25 mg
(telmisartan/hydrochlorothiazide)
Angiotensin II AT
1
Receptor Blocker/Diuretic
MANUFACTURED BY:
Alembic Pharmaceuticals Limited
Alembic Road,
Vadodara 390003,
Gujarat, India
IMPORTED AND DISTRIBUTED BY:
Alembic Pharmaceuticals Canada Ltd.
225 Gibraltar Road, Unit 5
Vaughan, Ontario
L4H 4P9, Canada
CONTROL NUMBER:
256615
DATE OF PREPARATION:
March 30, 2022
_ _
_Alembic-Telmisartan/HCTZ Product Monograph _
_Page 2 of 57_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................28
OVERDOSAGE
................................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STABILITY
..........................................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................36
PART II: SCIENTIFIC INFORMATION
...............................................................................