Composition:
Diadap 5: Each film coated tablet contains Dapagliflozin propanediol monohydrate, equivalent to 5 mg dapagliflozin.
Diadap 10: Each film coated tablet contains Dapagliflozin propanediol monohydrate, equivalent to 10 mg dapagliflozin.
Mechanism of action:
Dapagliflozin is an inhibitor of Sodium-glucose cotransporter 2 (SGLT2) in the proximal renal tubules, it reduces reabsorption of filtered glucose from the tubular lumen and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. improves both fasting and post-prandial plasmaglucose levels. Dapagliflozin does not impair normal endogenous glucose production in responseto hypoglycaemia. Dapagliflozin acts independently of insulin secretion and insulin action. Urinary glucose excretion (glucuresis) induced by dapagliflozin is associated with caloric loss and reduction in weight.
INDICATIONS:
It is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as:
Monotherapy: When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.
Add-on combination therapy: In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
Dosage and administration:
Recommended Dosing:
The recommended starting dose of Dapagliflozin is 5 mg once daily, taken in the morning, with or without food. In patients tolerating Dapagliflozin 5 mg once daily who require additional glycemic control, the dose can be increased to 10 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of Dapagliflozin is recommended.
Patients with Renal Impairment:
Assessment of renal function is recommended prior to initiation of Dapagliflozin therapy and periodically thereafter. Dapagliflozin should not be initiated in patients with an eGFR less than 60 mL/min/1.73 m². No dose adjustment is needed in patients with mild renal impairment (eGFR of 60 mL/min/1.73 m² or greater). Dapagliflozin should be discontinued when eGFR is persistently less than 60 mL/min/1.73 m².
Dapagliflozin is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m²
Presentation:
Diadap 5: Pack of 30 film coated tablets.
Diadap 10: Pack of 30 film coated tablets.