HYDROCHLOROTHIAZIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
24-05-2022
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Active ingredient:
HYDROCHLOROTHIAZIDE
Available from:
PRO DOC LIMITEE
ATC code:
C03AA03
INN (International Name):
HYDROCHLOROTHIAZIDE
Dosage:
50MG
Pharmaceutical form:
TABLET
Composition:
HYDROCHLOROTHIAZIDE 50MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
THIAZIDE DIURETICS
Product summary:
Active ingredient group (AIG) number: 0101048001; AHFS:
Authorization status:
APPROVED
Authorization date:
2019-04-01
Summary of Product characteristics
HYDROCHLOROTHIAZIDE Product Monograph Page 1 of 23
PRODUCT MONOGRAPH
PR
HYDROCHLOROTHIAZIDE
Hydrochlorothiazide Tablets USP
25 mg and 50 mg
DIURETIC - ANTIHYPERTENSIVE
Pro Doc Ltée
2925 Boul Industriel
Laval, Quebec
H7L 3W9
www.prodoc.qc.ca
Submission Control No: 263745
Date of Revision:
May 24, 2022
HYDROCHLOROTHIAZIDE Product Monograph Page 1 of 23
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
2
SUMMARY
PRODUCT
INFORMATION
..............................................................................................
2
INDICATIONS
AND
CLINICAL
USE
....................................................................................................
2
CONTRAINDICATIONS
.........................................................................................................................
3
WARNINGS
AND
PRECAUTIONS
........................................................................................................
3
ADVERSE
REACTIONS
.........................................................................................................................
7
DRUG
INTERACTIONS
..........................................................................................................................
7
DOSAGE
AND
ADMINISTRATION
....................................................................................................
11
OVERDOSAGE
......................................................................................................................................
12
ACTION
AND
CLINICAL
PHARMACOLOGY
..................................................................................
12
STORAGE
AND
STABILITY
................................................................................................................
13
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING
....................................................................
13
PART II: SCIENTIFIC INFORMATION
..................................................................
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