APO-SITAGLIPTIN-METFORMIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METFORMIN HYDROCHLORIDE; SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE)

Available from:

APOTEX INC

ATC code:

A10BD07

INN (International Name):

METFORMIN AND SITAGLIPTIN

Dosage:

500MG; 50MG

Pharmaceutical form:

TABLET

Composition:

METFORMIN HYDROCHLORIDE 500MG; SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) 50MG

Administration route:

ORAL

Units in package:

60/180/500

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0252656001; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-10-24

Summary of Product characteristics

_APO-SITAGLIPTIN-METFORMIN (Sitagliptin and metformin hydrochloride
Tablets) _
_Page 1 of 78 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-SITAGLIPTIN-METFORMIN
Sitagliptin (as sitagliptin phosphate monohydrate) and metformin
hydrochloride
Tablets, 50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg, oral
Combinations of oral blood glucose lowering drugs
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
December 18, 2014
Date of Revision:
March 10, 2022
Submission Control Number: 257275
_APO-SITAGLIPTIN-METFORMIN (Sitagliptin and metformin hydrochloride
Tablets) _
_Page 2 of 78 _
RECENT MAJOR LABEL CHANGES
1 Indications
03/2022
4 Dosage and Administration
03/2022
7 Warnings and Precautions
03/2022
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.......................................................................
5
1
INDICATIONS
................................................................................................................
5
1.1 Pediatrics
...............................................................................................................
5
1.2 Geriatrics
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5
2
CONTRAINDICATIONS
...................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.............................................................. 6
4
DOSAGE AND
ADMINISTRATION...................................................................................
6
4.1 Dosing Considerations
............................................................