APO-SITAGLIPTIN/METFORMIN XR TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE); METFORMIN HYDROCHLORIDE

Available from:

APOTEX INC

ATC code:

A10BD07

INN (International Name):

METFORMIN AND SITAGLIPTIN

Dosage:

100MG; 1000MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) 100MG; METFORMIN HYDROCHLORIDE 1000MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0252656004; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-10-24

Summary of Product characteristics

APO-SITAGLIPTIN/METFORMIN XR
Page 1 of 75
(Sitagliptin and metformin hydrochloride modified-release tablets)
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-SITAGLIPTIN/METFORMIN XR
Sitagliptin (as sitagliptin phosphate monohydrate) and metformin
hydrochloride
modified-release
Tablets, 50 mg/500 mg, 50 mg/1000 mg, and 100 mg/1000 mg, Oral
Combinations of oral blood glucose lowering drugs
APOTEX INC.
Date of Initial Authorization
150 Signet Drive
October 6, 2020
Toronto, Ontario
Date of Revision
M9L 1T9
February 25, 2022
Submission Control No: 257179
APO-SITAGLIPTIN/METFORMIN XR
Page 2 of 75
(Sitagliptin and metformin hydrochloride modified-release tablets)
RECENT MAJOR LABEL CHANGES
1 Indications
02/2022
4 Dosage and Administration
02/2022
7 Warnings and Precautions
02/2022
Sections or subsections that are not applicable at the time of
authorization are not
listed.
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
........................................................................
2
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
..............................................................