Type 2 diabetes mellitus: The recommended starting dose of JARDIANCE is 10 mg once daily. In patients tolerating empagliflozin 10 mg once daily who have an eGFR ≥30 mL/min/1.73 m2 and requiring additional glycaemic control, the dose can be increased to 25 mg once daily.
Combination therapy: When JARDIANCE is used in combination with a sulfonylurea or with insulin, a lower dose of the sulfonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see Interactions and Adverse Reactions).
Heart failure: The recommended dose of JARDIANCE is 10 mg once daily (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions).
Chronic kidney disease: The recommended dose of JARDIANCE is 10 mg once daily (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions).
JARDIANCE can be taken with or without food.
Patients with renal impairment: Assess renal function prior to initiation of empagliflozin and periodically thereafter.
Empagliflozin 10 mg can be used regardless of renal function. However, due to limited experience, it is not recommended to initiate treatment with JARDIANCE in patients with an eGFR <20 mL/min/1.73 m2 or on dialysis.
Glycaemic efficacy of empagliflozin is dependent on renal function and likely absent in patients with severe renal impairment. If eGFR falls below 30 mL/min/1.73 m2 the recommended dose of empagliflozin is limited to 10 mg and additional glucose lowering treatment should be considered if needed (see Precautions).
Patients with 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.
Elderly Patients: Type 2 Diabetes Mellitus: No dosage adjustment is recommended based on age. Therapeutic experience in patients aged 85 years and older is limited. Initiation of empagliflozin therapy in this population is not recommended (see Precautions). Patients aged 75 years and older should be prescribed with caution (see Precautions).
Heart Failure: No dosage adjustment is recommended based on age. Patients aged 75 years and older should be prescribed with caution (see Precautions).
Paediatric population: Safety and effectiveness of JARDIANCE in children under 18 years of age have not been established.