REDDY-SITAGLIPTIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
30-03-2023
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Active ingredient:
SITAGLIPTIN (SITAGLIPTIN PHOSPHATE)
Available from:
DR REDDY'S LABORATORIES LTD
ATC code:
A10BH01
INN (International Name):
SITAGLIPTIN
Dosage:
100MG
Pharmaceutical form:
TABLET
Composition:
SITAGLIPTIN (SITAGLIPTIN PHOSPHATE) 100MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0152414001; AHFS:
Authorization status:
APPROVED
Authorization date:
2023-03-31
Summary of Product characteristics
Page 1 of 58
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
REDDY-SITAGLIPTIN
Sitagliptin Tablets, USP
25, 50 and 100 mg (as sitagliptin phosphate), Oral
Dipeptidyl peptidase 4 (DPP-4) inhibitors
MANUFACTURED BY:
DR. REDDY’S LABORATORIES LTD.,
Bachupally – 500 090 India
IMPORTED AND DISTRIBUTED BY:
DR. REDDY’S LABORATORIES CANADA INC.
Mississauga, ON L4W 4Y1
Canada
Submission Control No: 241543
Date of Preparation:
March 30, 2023
Page 2 of 58
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
PART I: HEALTH PROFESSIONAL
INFORMATION..................................................................4
1
INDICATIONS............................................................................................................................4
1.1
Pediatrics............................................................................................................................4
1.2
Geriatrics............................................................................................................................4
2
CONTRAINDICATIONS.............................................................................................................4
4 DOSAGE AND
ADMINISTRATION...........................................................................................5
4.1 Dosing
Considerations........................................................................................................
5
4.2 Recommended Dose and Dosage
Adjustment...................................................................5
4.4
Administration.....................................................................................................................6
4.5 Missed
Dose.......................................................................................................................6
5
OVERDOSAGE.........................................................................................................................6
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND
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