EMPATOR

*Type 2 diabetes mellitus as monotherapy (if metformin inappropriate), Type 2 diabetes mellitus in combination with insulin or other antidiabetic drugs (if existing treatment fails to achieve adequate glycaemic control):* Adult 18-84 yrs: 10 mg once daily, may be increased to 25 mg once daily if necessary Adult 85 yrs and over: Initiation not recommended

Diabetic ketoacidosis, severe hepatic impairment, severe renal impairment. Elderly over 85 yrs age

Congestive heart failure and cardiovascular disease, hepatic impairment, renal impairment, complicated urinary tract infections; consider temporarily interrupting treatment. Avoid initiation if eGFR below 60 ml/minute/1.73m2. Avoid if eGFR is persistently below 45 ml/minute/1.73m2. Monitor renal function before starting treatment and regularly during treatment. Monitor electrolyte balance and ensure adequate hydration. Correct hypovolaemia before starting treatment. Consider interrupting treatment if volume depletion occurs, concomitant antihypertensive therapy or use of diuretics. Dose of concomitant insulin may need to be reduced.

Diuretics, antihypertensive, UGT enzyme inducers, agents affecting renal functions

Genital infection, hypoglycaemia (in combination with insulin or sulfonylurea), polyuria, pruritus, urinary tract infection, dysuria, volume depletion (rare)