ALDACTAZIDE 25 TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SPIRONOLACTONE; HYDROCHLOROTHIAZIDE

Available from:

PFIZER CANADA ULC

ATC code:

C03EA01

INN (International Name):

HYDROCHLOROTHIAZIDE AND POTASSIUM-SPARING AGENTS

Dosage:

25MG; 25MG

Pharmaceutical form:

TABLET

Composition:

SPIRONOLACTONE 25MG; HYDROCHLOROTHIAZIDE 25MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

MINERALOCORTICOID (ALDOSTERONE) RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0201064001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2020-04-01

Summary of Product characteristics

_ALDACTAZIDE (spironolactone and hydrochlorothiazide) _
_Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ALDACTAZIDE
® 25
Spironolactone and Hydrochlorothiazide Tablets
Tablets, 25mg/25mg, Oral
USP
PR
ALDACTAZIDE
® 50
Spironolactone and Hydrochlorothiazide Tablets
Tablets, 50mg/50mg, Oral
USP
Aldosterone Antagonist / Diuretic
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Initial Authorization:
NOV 10, 1960
Date of Revision:
JAN 25, 2022
®
TM Wyeth Holdings LLC
Pfizer Canada ULC, Licensee
©
Pfizer Canada ULC 2021
Submission Control Number: 253092
_ _
_ALDACTAZIDE (spironolactone and hydrochlorothiazide) _
_Page 2 of 42_
RECENT MAJOR LABEL CHANGES
WARNINGS AND PRECAUTIONS
01/2022
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................