MINT-LOSARTAN/HCTZ TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE

Available from:

MINT PHARMACEUTICALS INC

ATC code:

C09DA01

INN (International Name):

LOSARTAN AND DIURETICS

Dosage:

50MG; 12.5MG

Pharmaceutical form:

TABLET

Composition:

LOSARTAN POTASSIUM 50MG; HYDROCHLOROTHIAZIDE 12.5MG

Administration route:

ORAL

Units in package:

30/100/1000

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0233168001; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-07-27

Summary of Product characteristics

_MINT-LOSARTAN/HCTZ and MINT-LOSARTAN/HCTZ_
_ _
_DS _
_(losartan potassium and hydrochlorothiazide) _
_Page 1 of 44_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MINT-LOSARTAN/HCTZ
losartan potassium and hydrochlorothiazide tablets
Tablets, 50 mg / 12.5 mg and 100 mg / 12.5 mg, Oral
Pr
MINT-LOSARTAN/HCTZ DS
losartan potassium and hydrochlorothiazide tablets
Tablets, 100 mg / 25 mg, Oral
House Standard
Angiotensin II Receptor Antagonist and Diuretic
MINT PHARMACEUTICALS INC.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
JUL 27, 2012
Date of Revision:
FEB 14, 2023
Submission Control Number: 267752
_MINT-LOSARTAN/HCTZ and MINT-LOSARTAN/HCTZ_
_ _
_DS _
_(losartan potassium and hydrochlorothiazide) _
_Page 2 of 44_
_ _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Respiratory
02/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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