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Outline
What is the generic name?
EMPAGLIFLOZIN
What is the Trade Name for EMPAGLIFLOZIN?
Jardiance
What are the Indications for EMPAGLIFLOZIN?
- 1 INDICATIONS AND USAGE JARDIANCE is indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. • to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction. JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) • to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. ( 1 ) • to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction. ( 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 ) • Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m 2 ( 1 ) Limitations of Use JARDIANCE 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 (5.1) ] . JARDIANCE is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m 2 . JARDIANCE is likely to be ineffective in this setting based upon its mechanism of action.
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References: https://open.fda.gov/
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