APO-LISINOPRIL/HCTZ TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LISINOPRIL; HYDROCHLOROTHIAZIDE

Available from:

APOTEX INC

ATC code:

C09BA03

INN (International Name):

LISINOPRIL AND DIURETICS

Dosage:

20MG; 12.5MG

Pharmaceutical form:

TABLET

Composition:

LISINOPRIL 20MG; HYDROCHLOROTHIAZIDE 12.5MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0222417001; AHFS:

Authorization status:

APPROVED

Authorization date:

2007-11-21

Summary of Product characteristics

_APO-LISINOPRIL /HCTZ Lisinopril and Hydrochlorothiazide _
_ _
_Page 1 of 63 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-LISINOPRIL /HCTZ
Lisinopril and Hydrochlorothiazide
Tablets, 10 mg / 12.5 mg, 20 mg / 12.5 mg and 20 mg / 25 mg, Oral use
Angiotensin Converting Enzyme Inhibitor/Diuretic (C09BA03)
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
SEP 05, 2007
Date of Revision:
OCT 24, 2022
Submission Control Number: 264716
_APO-LISINOPRIL /HCTZ Lisinopril and Hydrochlorothiazide _
_ _
_Page 2 of 63 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions – Ophthalmologic
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
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS...................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
......................................................... 5
4
DOSAGE AND
ADMINISTRATION..................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
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