PMS-SITAGLIPTIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
14-12-2021
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Active ingredient:
SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE)
Available from:
PHARMASCIENCE INC
ATC code:
A10BH01
INN (International Name):
SITAGLIPTIN
Dosage:
100MG
Pharmaceutical form:
TABLET
Composition:
SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) 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:
2023-01-05
Summary of Product characteristics
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-SITAGLIPTIN
Sitagliptin Tablets
Tablets, 25, 50 and 100 mg sitagliptin (as sitagliptin phosphate
monohydrate) Oral
House Standard
Dipeptidyl peptidase 4 (DPP-4) inhibitors
PHARMASCIENCE INC
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
Date of Initial Authorization:
August 18, 2020
Date of Revision:
December 14, 2021
www.pharmascience.com
Submission Control Number: 254974
_pms-SITAGLIPTIN (sitagliptin) Page 2 of 56 _
RECENT MAJOR LABEL CHANGES
1 Indications
12/2021
4 Dosage and Administration
12/2021
7 Warnings and Precautions
12/2021
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
.........................................................................................4
4.1 Dosing
Considerations...................................................................................................4
4.2 Recommended Dose and Dosage
Adjustment...................................................................5
4.4 Administration
.............................................................................................................5
4.5 Missed Dose
................................................................................................................6
5
OVERDOSAGE
............................................
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