Adults with normal renal function (GFR ≥ 90ml/min): The recommended dose is one tablet twice daily. The dosage should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability. The maximum recommended daily dose of JARDIANCE DUO is 25 mg of empagliflozin and 2000 mg of metformin (see Table 13 for additional dosing information).
In patients not adequately controlled on metformin twice daily alone or in combination with other products, including insulin, the recommended starting dose of JARDIANCE DUO should provide empagliflozin 5 mg twice daily (10 mg total daily dose) and the dose of metformin similar to the dose already being taken. In patients tolerating a total daily dose of empagliflozin 10 mg and who need a tighter glycemic control, the dose can be increased to a total daily dose of empagliflozin 25 mg.
Patients switching from separate tablets of empagliflozin (10 mg or 25 mg total daily dose) and metformin (dose taken twice-daily) to JARDIANCE DUO should receive the same daily dose of empagliflozin and metformin.
When JARDIANCE DUO is used in combination with a sulphonylurea and/or insulin, a lower dose of sulphonylurea and/or insulin may be required to reduce the risk of hypoglycaemia (see Interactions and Adverse Reactions.)
For the different doses of metformin, JARDIANCE DUO is available in strengths of 5 mg empagliflozin plus 500 mg, 850 mg or 1000 mg metformin hydrochloride or 12.5 mg empagliflozin plus 500 mg, 850 mg or 1000 mg metformin hydrochloride. Not all strength presentation may be available locally.
JARDIANCE DUO should be given with meals to reduce the gastrointestinal undesirable effects associated with metformin.
Missed dose: If a dose is missed, it should be taken as soon as the patient remembers. However, a double dose should not be taken at the same time. In that case, the missed dose should be skipped.
Special Populations: Patients with renal impairment: No dose adjustment is recommended for patients with mild renal impairment.
A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months. (See Table 13.)
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Paediatric population: JARDIANCE DUO is not recommended for use in children below 18 years due to lack of data on safety and efficacy.
Elderly patients: In patients 75 years and older, an increased risk for volume depletion should be taken into account. In patients aged 85 years and older, initiation of empagliflozin therapy is not recommended due to the limited therapeutic experience.