Country: Canada
Language: English
Source: Health Canada
SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE)
SANDOZ CANADA INCORPORATED
A10BH03
SAXAGLIPTIN
5MG
TABLET
SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE) 5MG
ORAL
30/100
Prescription
DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS
Active ingredient group (AIG) number: 0152653001; AHFS:
APPROVED
2021-03-08
_Sandoz Saxagliptin _ _Page 1 of 43_ PRODUCT MONOGRAPH PR SANDOZ SAXAGLIPTIN Saxagliptin Tablets Saxagliptin (as saxagliptin hydrochloride dihydrate) 2.5 mg and 5 mg Oral Antihyperglycemic Agent DPP-4 inhibitor Incretin Enhancer Sandoz Canada Inc. 110 Rue de Lauzon Boucherville, Québec J4B 1E6 Date of Revision: February 25, 2019 Submission Control No: 224039 _Sandoz Saxagliptin _ _Page 2 of 43_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .............................................................. 3 SUMMARY PRODUCT INFORMATION ............................................................................ 3 INDICATIONS AND CLINICAL USE .................................................................................. 3 CONTRAINDICATIONS ....................................................................................................... 4 WARNINGS AND PRECAUTIONS ...................................................................................... 4 ADVERSE REACTIONS ........................................................................................................ 7 DRUG INTERACTIONS ...................................................................................................... 15 DOSAGE AND ADMINISTRATION .................................................................................. 19 OVERDOSAGE .................................................................................................................... 20 ACTION AND CLINICAL PHARMACOLOGY ................................................................ 20 STORAGE AND STABILITY .............................................................................................. 23 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................. 24 PART II: SCIENTIFIC INFORMATION .................................................................................... 25 PHARMACEUTICAL INFORMATION .............................................................................. 25 CLINICAL TRIALS ................ Read the complete document