PRO-SAXAGLIPTIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-01-2022
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Active ingredient:
SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE)
Available from:
PRO DOC LIMITEE
ATC code:
A10BH03
INN (International Name):
SAXAGLIPTIN
Dosage:
2.5MG
Pharmaceutical form:
TABLET
Composition:
SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE) 2.5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0152653002; AHFS:
Authorization status:
APPROVED
Authorization date:
2022-01-18
Summary of Product characteristics
Page 1 of 43
PRODUCT MONOGRAPH
PR
PRO-SAXAGLIPTIN
Saxagliptin Tablets
2.5mg and 5mg saxagliptin (as saxagliptin hydrochloride)
Oral Antihyperglycemic Agent
DPP-4 inhibitor
Incretin Enhancer
PRO DOC LTÉE Date of Preparation
2925 boul. Industriel January 12, 2022
Laval, Québec
H7L 3W9
Submission Control No.: 259612
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
..............................................................................................................................
16
DOSAGE AND ADMINISTRATION
..........................................................................................................
20
OVERDOSAGE
............................................................................................................................................
21
ACTION AND CLINICAL
PHARMACOLOGY.........................................................................................
21
STORAGE AND STABILITY
......................................................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................................
24
PART II: SCIENTIFIC INFORMATION
.....................
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