Catania Dosage/Direction for Use

Posology: Type 2 diabetes mellitus: The recommended dose is 10 mg dapagliflozin once daily.
When dapagliflozin is used in combination with insulin or an insulin secretagogue, such as a sulphonylurea, a lower dose of insulin or insulin secretagogue may be considered to reduce the risk of hypoglycaemia.
Heart failure: The recommended dose is 10 mg dapagliflozin once daily.
In the DAPA-HF study, dapagliflozin was administered in conjunction with other heart failure therapies.
Chronic kidney disease: The recommended dose is 10 mg dapagliflozin once daily.
In the DAPA-CKD study, dapagliflozin was administered in conjunction with other chronic kidney disease related therapies.
Special populations: Renal impairment: No dose adjustment is required based on renal function.
It is not recommended to initiate treatment with dapagliflozin in patients with an estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m².
In patients with type 2 diabetes mellitus, the glucose lowering efficacy of dapagliflozin is reduced when eGFR is < 45 mL/min/1.73 m², and is likely absent in patients with severe renal impairment. Therefore, if eGFR falls below 45 mL/min/1.73 m², additional glucose lowering treatment should be considered in patients with type 2 diabetes mellitus.
Hepatic impairment: No dose adjustment is necessary for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, a starting dose of 5 mg is recommended. If well tolerated, the dose may be increased to 10 mg.
Elderly (≥ 65 years): No dose adjustment is recommended based on age.
Paediatric population: No dose adjustment is required for the treatment of type 2 diabetes mellitus in children aged 10 years and above. No data are available for children below 10 years of age.
The safety and efficacy of dapagliflozin for the treatment of heart failure or for the treatment of chronic kidney disease in children < 18 years have not yet been established. No data are available.
Method of administration: Dapagliflozin tablets can be taken orally once daily at any time of day with or without food. Tablets are to be swallowed whole.