sitagliptin

FDA Drug Profile — JANUVIA

Drug Details

Generic Name
sitagliptin
Brand Names
JANUVIA
Application Number
NDA021995
Sponsor
A-S Medication Solutions
NDC Codes
13
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
SITAGLIPTIN PHOSPHATE

Indications and Usage

1 INDICATIONS AND USAGE JANUMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use JANUMET should not be used in patients with type 1 diabetes mellitus. JANUMET has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET. [See Warnings and Precautions (5.2) .] JANUMET is a combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: JANUMET should not be used in patients with type 1 diabetes. ( 1 ) JANUMET has not been studied in patients with a history of pancreatitis. ( 1 , 5.2 )