Adjunct to diet & exercise to improve glycaemic control in adults ≥18 yr w/ type 2 DM as monotherapy; add-on combination w/ glucose-lowering medicinal products eg, insulin; as initial combination therapy w/ metformin (includes poor prospects for response to metformin monotherapy). Reduce risk of hospitalization for heart failure in adults w/ type 2 DM & established CV disease or multiple CV risk factors. Reduce risk of CV death & hospitalization for heart failure in adults w/ NYHA class II-IV heart failure w/ reduced ejection fraction. CKD.
Dosage/Direction for Use
Type 2 DM monotherapy & add-on combination therapy 10 mg once daily. Combination w/ insulin or insulin secretagogue Lower dose of insulin or insulin secretagogue may be considered. Initial combination therapy Dapagliflozin 10 mg + metformin 500 mg once daily. Heart failure & CKD 10 mg once daily. Severe hepatic impairment Initially 5 mg, may be increased to 10 mg if well tolerated.
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