sitagliptin and metformin hydrochloride
Drug Details
- Generic Name
- sitagliptin and metformin hydrochloride
- Brand Names
- Sitagliptin and Metformin Hydrochloride, JANUMET XR, ZITUVIMET XR
- Application Number
- NDA216778
- Sponsor
- Zydus Lifesciences Limited
- NDC Codes
- 16
- Dosage Forms
- TABLET, FILM COATED, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- METFORMIN HYDROCHLORIDE, SITAGLIPTIN, SITAGLIPTIN PHOSPHATE
Indications and Usage
1 INDICATIONS AND USAGE JANUMET ® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUMET XR 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: Not for the treatment of type 1 diabetes. ( 1 ) Has not been studied in patients with a history of pancreatitis. ( 1 , 5.2 ) Limitations of Use JANUMET XR should not be used in patients with type 1 diabetes mellitus. JANUMET XR 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 XR. [See Warnings and Precautions (5.2) .]