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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 (see Interactions and Adverse Reactions).
Heart failure: The recommended dose is 10 mg dapagliflozin once daily.
Chronic kidney disease: The recommended dose is 10 mg dapagliflozin once daily.
Special populations: Renal impairment: No dose adjustment is required based on renal function.
Due to limited experience, it is not recommended to initiate treatment with dapagliflozin in patients with GFR < 25 mL/min.
In patients with type 2 diabetes mellitus, the glucose lowering efficacy of dapagliflozin is reduced when the glomerular filtration rate (GFR) is < 45 mL/min and is likely absent in patients with severe renal impairment. Therefore, if GFR falls below 45 mL/min, additional glucose lowering treatment should be considered in patients with type 2 diabetes mellitus if further glycaemic control is needed (see Precautions, Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
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 (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Elderly (≥ 65 years): No dose adjustment is recommended based on age.
Paediatric population: The safety and efficacy of dapagliflozin in children aged 0 to < 18 years have not yet been established.
No data are available.
Method of administration: Forxiga can be taken orally once daily at any time of day with or without food. Tablets are to be swallowed whole.
