Forxiga Dosage/Direction for Use

Posology: Type 2 diabetes mellitus: Add-on combination therapy: The recommended dose is 10 mg dapagliflozin once daily for add-on combination therapy with metformin; pioglitazone; sitagliptin (with or without metformin); or gliclazide, glimepiride, or glyburide (with or without metformin); or insulin (alone or with up two antidiabetic medications). When dapagliflozin is used in combination with an insulin secretagogue, such as gliclazide, glimepiride, or glyburide, a lower dose of 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.
Based on DAPA-HF study, dapagliflozin is not recommended for patients with acute decompensated heart failure, symptomatic hypotension or systolic BP <95 mmHg, type 1 diabetes mellitus, or severe renal impairment (GFR <30 mL/min).
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 therapies (see Pharmacology: Pharmacodynamics under Actions).
Special populations: Treatment of diabetes mellitus in patients with renal impairment: As glycaemic efficacy is dependent on renal function, Forxiga should not be initiated to improve glycaemic control in patients with a glomerular filtration rate [GFR] <60 mL/min and should be discontinued at GFR persistently below 45 mL/min (see Precautions, Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
No dosage adjustment is needed in patients with GFR ≥45 mL/min.
Treatment of heart failure in patients with renal impairment: No dose adjustment is required based on renal function (see Precautions).
Dapagliflozin is not recommended in patients with severe renal impairment (GFR <30 mL/min).
Treatment of chronic kidney disease in patients with renal impairment: No dose adjustment is required based on renal function (see Precautions).
Due to limited experience, dapagliflozin is not recommended to be initiated in patients with severe renal impairment (GFR <30 mL/min).
Hepatic impairment: No dosage 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): In general, no dosage adjustment is recommended based on age. Renal function and risk of volume depletion should be taken into account (see Precautions and Pharmacology: Pharmacokinetics under Actions).
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.