Jardiance

Jardiance Dosage/Direction for Use

empagliflozin

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Full Prescribing Info
Dosage/Direction for Use
Posology: Type 2 diabetes mellitus: Monotherapy and add-on combination: The recommended starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other medicinal products including insulin. In patients tolerating empagliflozin 10 mg once daily 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).
Heart failure (HF): The recommended dose of JARDIANCE is 10 mg once daily.
Chronic kidney disease: The recommended dose of JARDIANCE is 10 mg once daily.
Special populations: Renal impairment: Due to limited experience, it is not recommended to initiate treatment with JARDIANCE in patients with an eGFR <20 ml/min/1.73 m2.
Glycaemic efficacy of empagliflozin is dependent on renal function and reduced in patients with an eGFR <45 ml/min/1.73 m2 and likely absent in patients with an eGFR<30 ml/min/1.73 m2. If eGFR falls below 45 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).
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 patients: 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).
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.
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