Active ingredients
DAPAVELDACTIN 5 mg® :
• Film Coated Tablets
• Each Film Coated tablet contains dapagliflozin propanediol monohydrate 6.15 mg equivalent to 5 mg dapagliflozin.
DAPAVELDACTIN 10 mg® :
• Film Coated Tablets
• Each Film Coated tablet contains dapagliflozin propanediol monohydrate 12.30 mg equivalent to 10 mg dapagliflozin.
Indications
Type 2 Diabetes Mellitus
DAPAVELDACTIN® (dapagliflozin) 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 hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.
Heart Failure
DAPAVELDACTIN® is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction.
• 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.
Mechanism of Action
Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Dapagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule. This may influence several physiological functions including, but not restricted to, lowering both pre-and afterload of the heart and downregulation of sympathetic activity.
Limitations of Use
DAPAVELDACTIN® is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Dosage & Administration
DAPAVELDACTIN® is taken orally once daily in the morning with food.