Posology : מינונים

5    DOSAGE AND ADMINISTRATION

5.1 Adults with normal renal function (glomerular filtration rate [GFR] ≥ 90 ml/min)
• In patients with volume depletion not previously treated with empagliflozin, correct this condition before initiating JARDIANCE DUO [see Warnings and Precautions (8.2)].
• Individualize the starting dose of JARDIANCE DUO based on the patient’s current regimen: − In patients on metformin hydrochloride, switch to JARDIANCE DUO containing empagliflozin 5 mg with a similar total daily dose of metformin hydrochloride;
− In patients already treated with empagliflozin and metformin hydrochloride, switch to JARDIANCE DUO containing the same total daily doses of each component.
• Take JARDIANCE DUO twice daily with meals; with gradual dose escalation to reduce the gastrointestinal side effects due to metformin [see Dosage Forms and Strengths (6)].
• Adjust dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of JARDIANCE DUO (metformin hydrochloride 2000 mg and empagliflozin 25 mg) [see Dosage and Administration (5.2)].

5.2 Recommended Dosage in Patients with Renal Impairment

A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at an 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.
The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis [see Warnings and Precautions (8.1)] should be reviewed before considering initiation of metformin in patients with GFR<60 ml/min.
If no adequate strength of Jardiance Duo is available, individual monocomponents should be used instead of the fixed dose combination.



Jardiance Duo                                                                               Updated prescribing information 5mg/850mg, 5mg/1000mg, 12.5mg/850mg, 12.5mg/1000mg                                                                May 2024 GFR ml/min                                  metformin                                    empagliflozin 60-89                 Maximum daily dose is 2550 mg             Maximum daily dose is 25 mg.
Dose reduction may be considered in relation to declining renal function.
45-59                 Maximum daily dose is 2000 mg             No dose adjustment is required.
The starting dose is at most half of the maximum dose.
30-44                 Maximum daily dose is 1000 mg.            Empagliflozin is contraindicated.
The starting dose is at most half of the maximum dose.
<30                   Metformin is contraindicated              Empagliflozin is contraindicated.



5.3 Discontinuation for Iodinated Contrast Imaging Procedures
Discontinue JARDIANCE DUO at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 45 and 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re- evaluate eGFR 48 hours after the imaging procedure; restart JARDIANCE DUO if renal function is stable [see Warnings and Precautions (8.1)].

6   DOSAGE FORMS AND STRENGTHS
JARDIANCE DUO Tablets:

Empagliflozin        Metformin HCl              Color/Shape                         Tablet Markings Strength              Strength
5 mg                 850 mg               yellowish white, oval,          Boehringer Ingelheim company symbol biconvex, film-coated tablet    and “S5” debossed on one side; the other side is debossed with “850”
5 mg                 1,000 mg             brownish yellow, oval,          Boehringer Ingelheim company symbol biconvex, film-coated tablet    and “S5” debossed on one side; the other side is debossed with “1000”
12.5 mg              850 mg               pinkish white, oval,            Boehringer Ingelheim company symbol biconvex, film-coated tablet    and “S12” debossed on one side; the other side is debossed with “850”
12.5 mg              1,000 mg             dark brownish purple, oval,     Boehringer Ingelheim company symbol biconvex, film-coated tablet    and “S12” debossed on one side; the other side is debossed with “1000”