REDDY-SITAGLIPTIN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE)

Commercializzato da:

DR REDDY'S LABORATORIES LTD

Codice ATC:

A10BH01

INN (Nome Internazionale):

SITAGLIPTIN

Dosaggio:

25MG

Forma farmaceutica:

TABLET

Composizione:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE) 25MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Dettagli prodotto:

Active ingredient group (AIG) number: 0152414002; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2023-03-31

Scheda tecnica

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