sitagliptin
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 JANUVIA ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA 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: JANUVIA should not be used in patients with type 1 diabetes ( 1 ) JANUVIA has not been studied in patients with a history of pancreatitis. ( 1 , 5.1 ) Limitations of Use JANUVIA should not be used in patients with type 1 diabetes. JANUVIA 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 JANUVIA. [See Warnings and Precautions (5.1) .]