linagliptin
Drug Details
- Generic Name
- linagliptin
- Brand Names
- Tradjenta, linagliptin
- Application Number
- NDA201280
- Sponsor
- Boehringer Ingelheim Pharma GmbH and Co. KG
- NDC Codes
- 6
- Dosage Forms
- POWDER, TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- LINAGLIPTIN
Indications and Usage
1 INDICATIONS AND USAGE Linagliptin and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Linagliptin and metformin hydrochloride tablets are not recommended in patients with type 1 diabetes mellitus. Linagliptin and metformin hydrochloride tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using linagliptin and metformin hydrochloride tablets [see Warnings and Precautions (5.2 )]. Linagliptin and metformin hydrochloride tablets are a combination of linagliptin, 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 recommended in patients with type 1 diabetes mellitus ( 1 ) • Has not been studied in patients with a history of pancreatitis ( 1 )