M-SITAGLIPTIN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE)

Disponible depuis:

MANTRA PHARMA INC

Code ATC:

A10BH01

DCI (Dénomination commune internationale):

SITAGLIPTIN

Dosage:

50MG

forme pharmaceutique:

TABLET

Composition:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE) 50MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Descriptif du produit:

Active ingredient group (AIG) number: 0152414003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2023-02-06

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
M-SITAGLIPTIN
sitagliptin tablets
Tablets, 25, 50 and 100 mg sitagliptin (as sitagliptin phosphate
anhydrous), Oral
House Standard
ATC Code: A10BH01
Dipeptidyl peptidase 4 (DPP-4) inhibitors
Mantra Pharma Inc.
9150 Leduc Blvd., Suite 201
Brossard, Quebec
J4Y 0E3
Submission Control Number: 270679
Date of
Initial Authorization:
FEB
02, 2023
_Product Monograph – M-SITAGLIPTIN_
_Page 2 of 54_
RECENT MAJOR LABEL CHANGES
N/A
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TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
..............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration
..........................................................................................................
5
4.5
Missed Dose
......................................................................................