SITAGLIPTIN-METFORMIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE); METFORMIN HYDROCHLORIDE

Available from:

SIVEM PHARMACEUTICALS ULC

ATC code:

A10BD07

INN (International Name):

METFORMIN AND SITAGLIPTIN

Dosage:

50MG; 500MG

Pharmaceutical form:

TABLET

Composition:

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

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2023-01-05

Summary of Product characteristics

_ _
_SITAGLIPTIN-METFORMIN (Sitagliptin and metformin hydrochloride
tablets) _
_Page 1 of 72_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SITAGLIPTIN-METFORMIN
Sitagliptin and metformin hydrochloride tablets
Tablets, 50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg sitagliptin (as
sitagliptin phosphate
monohydrate) / metformin hydrochloride, Oral
Combinations of oral blood glucose lowering drugs
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Submission Control Number: 279764
Date of Initial Authorization:
JAN 5, 2023
Date of Revision:
OCT 20, 2023
_ _
_SITAGLIPTIN-METFORMIN (Sitagliptin and metformin hydrochloride
tablets) _
_Page 2 of 72_
RECENT MAJOR LABEL CHANGES
1 Indications
10/2023
4 Dosage and Administration
10/2023
7 Warnings and Precautions
10/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosing Considerations
..............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
......................................................... 6
4.4
Administration
......................