Country: Canada
Language: English
Source: Health Canada
METFORMIN HYDROCHLORIDE; SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE)
APOTEX INC
A10BD07
METFORMIN AND SITAGLIPTIN
1000MG; 50MG
TABLET
METFORMIN HYDROCHLORIDE 1000MG; SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) 50MG
ORAL
60/180/500
Prescription
Active ingredient group (AIG) number: 0252656003; AHFS:
APPROVED
2022-10-24
_APO-SITAGLIPTIN-METFORMIN (Sitagliptin and metformin hydrochloride Tablets) _ _Page 1 of 78 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-SITAGLIPTIN-METFORMIN Sitagliptin (as sitagliptin phosphate monohydrate) 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 APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Initial Authorization: December 18, 2014 Date of Revision: March 10, 2022 Submission Control Number: 257275 _APO-SITAGLIPTIN-METFORMIN (Sitagliptin and metformin hydrochloride Tablets) _ _Page 2 of 78 _ RECENT MAJOR LABEL CHANGES 1 Indications 03/2022 4 Dosage and Administration 03/2022 7 Warnings and Precautions 03/2022 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ............................................................................................. 2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION....................................................................... 5 1 INDICATIONS ................................................................................................................ 5 1.1 Pediatrics ............................................................................................................... 5 1.2 Geriatrics ............................................................................................................... 5 2 CONTRAINDICATIONS ................................................................................................... 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................................. 6 4 DOSAGE AND ADMINISTRATION................................................................................... 6 4.1 Dosing Considerations ............................................................ Read the complete document