sitagliptin phosphate

FDA Drug Profile

Drug Details

Generic Name
sitagliptin phosphate
Brand Names
N/A
Application Number
Sponsor
Alivus Life Sciences Limited
NDC Codes
1
Dosage Forms
POWDER
Routes
N/A
Active Ingredients
SITAGLIPTIN PHOSPHATE

Indications and Usage

1 INDICATIONS AND USAGE Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Sitagliptin tablets should not be used in patients with type 1 diabetes. Sitagliptin tablets have 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 sitagliptin tablets. [See Warnings and Precautions ( 5.1 ).] Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: • Sitagliptin tablets should not be used in patients with type 1 diabetes. ( 1 ) • Sitagliptin tablets have not been studied in patients with a history of pancreatitis. ( 1 , 5.1 )