What is the generic name?

EMPAGLIFLOZIN, LINAGLIPTIN, METFORMIN HYDROCHLORIDE

What is the Trade Name for EMPAGLIFLOZIN, LINAGLIPTIN, METFORMIN HYDROCHLORIDE?

Trijardy XR

What are the Indications for EMPAGLIFLOZIN, LINAGLIPTIN, METFORMIN HYDROCHLORIDE?

• 1 INDICATIONS AND USAGE TRIJARDY XR is a combination of empagliflozin, linagliptin, and metformin hydrochloride (HCl) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease [see Clinical Studies (14) ] . TRIJARDY XR is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, 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. Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. ( 1 ) Limitations of Use Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients ( 1 ) Has not been studied in patients with a history of pancreatitis ( 1 ) Limitations of Use TRIJARDY XR is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.3) ] . TRIJARDY XR has 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 TRIJARDY XR [see Warnings and Precautions (5.2) ].

References: https://open.fda.gov/