PRO-SITAGLIPTIN MALATE / METFORMIN HYDROCHLORIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
09-01-2023
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Active ingredient:
SITAGLIPTIN (SITAGLIPTIN MALATE); METFORMIN HYDROCHLORIDE
Available from:
PRO DOC LIMITEE
ATC code:
A10BD07
INN (International Name):
METFORMIN AND SITAGLIPTIN
Dosage:
50MG; 850MG
Pharmaceutical form:
TABLET
Composition:
SITAGLIPTIN (SITAGLIPTIN MALATE) 50MG; METFORMIN HYDROCHLORIDE 850MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0252656002; AHFS:
Authorization status:
APPROVED
Authorization date:
2023-01-11
Summary of Product characteristics
PRO-SITAGLIPTIN MALATE / METFORMIN HYDROCHLORIDE
Page 1 of 69
Sitagliptin and metformin hydrochloride tablets
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRO-SITAGLIPTIN MALATE / METFORMIN HYDROCHLORIDE
Sitagliptin (as sitagliptin malate) 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
PRO DOC LTÉE
2925 boul. Industriel
Laval, Québec
H7L 3W9
Date of Initial Authorization:
JAN 9, 2023
Submission Control No.: 269818
PRO-SITAGLIPTIN MALATE / METFORMIN HYDROCHLORIDE
Page 2 of 69
Sitagliptin and metformin hydrochloride tablets
RECENT MAJOR LABEL CHANGES
N/A
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
................................................................................
5
4.1
Dosing Considerations
....................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................................ 6
4.4
Administration
.................................................................................................................
7
4.5
Missed Dose
...........
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