Posology: Monotherapy and add-on combination: The recommended starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other glucose-lowering medicinal products including insulin. In patients tolerating empagliflozin 10 mg once daily who have an eGFR ≥45 ml/min/1.73 m2 and need tighter glycaemic control, the dose can be increased to 25 mg once daily. The maximum daily dose is 25 mg (see as follows and Precautions).
When empagliflozin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see Interactions and Adverse Reactions).
Special populations: Renal impairment: Due to the mechanism of action, the glycaemic efficacy of empagliflozin is dependent on renal function. No dose adjustment is required for patients with an eGFR ≥45 ml/min/1.73 m2 or CrCl ≥45 ml/min.
Empagliflozin should not be initiated in patients with an eGFR <45 ml/min/1.73 m2 or CrCl <45 ml/min. Empagliflozin should be discontinued when eGFR is persistently below 45 ml/min/1.73 m2 or CrCl persistently below 45 ml/min and is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2 (see Precautions, Adverse Reactions, Pharmacology and Pharmacology: Pharmacokinetics under Actions).
Empagliflozin should not be used in patients with end stage renal disease (ESRD) or in patients on dialysis as it is not expected to be effective in these patients (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is required for patients with hepatic impairment. Empagliflozin exposure is increased in patients with severe hepatic impairment. Therapeutic experience in patients with severe hepatic impairment is limited and therefore not recommended for use in this population (see Pharmacology: Pharmacokinetics under Actions).
Elderly: No dose adjustment is recommended based on age. In patients 75 years and older, an increased risk for volume depletion should be taken into account (see Precautions and Adverse Reactions). In patients aged 85 years and older, initiation of empagliflozin therapy is not recommended due to the limited therapeutic experience (see Precautions).
Paediatric population: The safety and efficacy of empagliflozin in children and adolescents has not yet been established. No data are available.
Method of administration: The tablets can be taken with or without food, swallowed whole with water. If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.