TEVA-SPIRONOLACTONE/HCTZ TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

SPIRONOLACTONE; HYDROCHLOROTHIAZIDE

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

C03EA01

DCI (Dénomination commune internationale):

HYDROCHLOROTHIAZIDE AND POTASSIUM-SPARING AGENTS

Dosage:

50MG; 50MG

forme pharmaceutique:

TABLET

Composition:

SPIRONOLACTONE 50MG; HYDROCHLOROTHIAZIDE 50MG

Mode d'administration:

ORAL

Unités en paquet:

100/500/1000

Type d'ordonnance:

Prescription

Domaine thérapeutique:

MINERALOCORTICOID (ALDOSTERONE) RECEPTOR ANTAGONISTS

Descriptif du produit:

Active ingredient group (AIG) number: 0201064002; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2011-06-14

Résumé des caractéristiques du produit

TEVA-SPIRONOLACTONE/HCTZ
Page 1 of 49
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-SPIRONOLACTONE/HCTZ
Spironolactone and Hydrochlorothiazide Tablets,
Tablets, 25 mg of spironolactone and 25 mg of hydrochlorothiazide
50 mg of spironolactone and 50 mg of hydrochlorothiazide,
Oral
USP
Aldosterone Antagonist / Diuretic
Teva Canada Limited
Date of Initial Authorization:
30 Novopharm Court
June 28, 2011
Toronto, Ontario
Canada M1B 2K9 Date of Revision:
www.tevacanada.com
October 20, 2022
Submission Control No: 264744
TEVA-SPIRONOLACTONE/HCTZ
Page 2 of 49
RECENT MAJOR LABEL CHANGES
WARNINGS AND PRECAUTIONS
10/2022
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
................................................................................................................
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
......................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment.................................................... 6
4.4
Adminisrtat