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

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE); METFORMIN HYDROCHLORIDE

Disponible desde:

APOTEX INC

Código ATC:

A10BD07

Designación común internacional (DCI):

METFORMIN AND SITAGLIPTIN

Dosis:

100MG; 1000MG

formulario farmacéutico:

TABLET (EXTENDED-RELEASE)

Composición:

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

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2022-10-24

Ficha técnica

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
..............................................................