What is the generic name?

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

What is the Trade Name for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE?

XIGDUO XR

What are the Indications for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE?

• 1 INDICATIONS AND USAGE XIGDUO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin is indicated to reduce ‚Ä¢ the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. ‚Ä¢ the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction. Limitations of Use ‚Ä¢ XIGDUO XR is not recommended for patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. ‚Ä¢ Because of the metformin component, the use of XIGDUO XR is limited to adults with type 2 diabetes mellitus for all indications. XIGDUO XR is a combination of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and metformin, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1) Dapagliflozin is indicated to reduce: ‚Ä¢ the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors. (1) ‚Ä¢ the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction. (1) Limitations of use : ‚Ä¢ Not for treatment of type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. (1) ‚Ä¢ Because of the metformin component, the use of XIGDUO XR is limited to adults with type 2 diabetes mellitus for all indications. (1)

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