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Outline
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 • 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. • 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 • XIGDUO XR is not recommended for patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. • 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: • the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors. (1) • 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 : • Not for treatment of type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. (1) • Because of the metformin component, the use of XIGDUO XR is limited to adults with type 2 diabetes mellitus for all indications. (1)
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References: https://open.fda.gov/
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