Posology : מינונים

5    DOSAGE AND ADMINISTRATION
5.1 Dosage Adults with normal renal function (glomerular filtration rate [GFR] ≥ 90 ml/min) The dosage of TRAJENTA DUO should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended dosage of 2.5 mg linagliptin/1,000 mg metformin hydrochloride (HCl), taken orally twice daily. TRAJENTA DUO should be given twice daily with meals. Dosage escalation should be gradual to reduce the gastrointestinal (GI) side effects associated with metformin use. For available dosage forms and strengths [see Dosage Forms and Strengths (6)].

Recommended starting dosage:
• In patients currently not treated with metformin HCl, initiate treatment with 2.5 mg linagliptin/500 mg metformin HCl twice daily
• In patients already treated with metformin HCl, start with 2.5 mg linagliptin and the current dosage of metformin HCl taken at each of the two daily meals (e.g., a patient on metformin HCl 1,000 mg twice daily would be started on 2.5 mg linagliptin/1,000 mg metformin HCl twice daily with meals).
• Patients already treated with linagliptin and metformin HCl individual components may be switched to TRAJENTA DUO containing the same dosages of each component.

No studies have been performed specifically examining the safety and efficacy of TRAJENTA DUO in patients previously treated with other oral antihyperglycemic agents and switched to TRAJENTA DUO. Any change in therapy of type 2 diabetes mellitus should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.

5.2 Recommended Dosing in 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.
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.
Boehringer Ingelheim Israel                                                                                  2 Trajenta duo                                                                           Prescribing Information File coated tablets 2.5mg/500mg, 2.5mg/850mg, 2.5mg/1,000mg                                    September 2023 If no adequate strength of Trajenta Duo is available, individual monocomponents should be used instead of the fixed dose combination.

GFR ml/min          metformin                                  linagliptin 60-89                Maximum daily dose is 2550 mg              No dose adjustment Dose reduction may be considered in relation to declining renal function.
45-59                Maximum daily dose is 2000 mg              No dose adjustment
The starting dose is at most half of the maximum dose.
30-44                Maximum daily dose is 1000 mg.             No dose adjustment The starting dose is at most half of the maximum dose.
<30                  Metformin is contraindicated               No dose adjustment 

6   DOSAGE FORMS AND STRENGTHS
TRAJENTA DUO tablets are a combination of linagliptin and metformin HCl available as:
• 2.5 mg linagliptin/500 mg metformin HCl tablets are light yellow, oval, biconvex tablets debossed with “D2/500” on one side and the Boehringer Ingelheim symbol on the other side
• 2.5 mg linagliptin/850 mg metformin HCl tablets are light orange, oval, biconvex tablets debossed with “D2/850” on one side and the Boehringer Ingelheim symbol on the other side
• 2.5 mg linagliptin/1000 mg metformin HCl tablets are light pink, oval, biconvex tablets debossed with “D2/1,000” on one side and the Boehringer Ingelheim symbol on the other side