Posology : מינונים

2        DOSAGE AND ADMINISTRATION

2.1     Adults with normal renal function (estimated glomerular filtration rate [eGFR]        ≥ 90 mL/min/173 m2)

The dosage of JANUET should be individualized on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin hydrochloride (HCl). Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the health care provider.

JANUET should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects due to metformin.

There is no information about crushing, splitting, or chewing these tablets.

The starting dose of JANUET should be based on the patient’s          current regimen.   JANUET should be given twice daily with meals. The following doses are available:

50 mg sitagliptin/500 mg metformin HCl

50 mg sitagliptin/850 mg metformin HCl
50 mg sitagliptin/1000 mg metformin HCl

The recommended starting dose in patients not currently treated with metformin is 50 mg sitagliptin/500 mg metformin HCl twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with metformin.

The starting dose in patients already treated with metformin should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of metformin already being taken.


Patients treated with an insulin secretagogue or insulin

Coadministration of JANUET with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia 

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

2.2 Recommendations for Use in Renal Impairment

An eGFR 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 (5.1)] should be reviewed before considering initiation of metformin in patients with eGFR<60 mL/min/1.73 m2.

If no adequate strength of JANUET is available, individual monocomponents should be used instead of the fixed dose combination.
eGFR mL/min/1.73 m2                        Metformin                    Sitagliptin 

60-89                        Maximum daily dose is 2550 mg.             Maximum daily dose is 100 mg.
Dose reduction may be considered in relation to declining renal function.
45-59                        Maximum daily dose is 2000 mg.             Maximum daily dose is 100 mg.
The starting dose is at most half of the maximum dose.

30-44                        Maximum daily dose is 1000 mg.             Maximum daily dose is 50 mg.
The starting dose is at most half of the maximum dose.

< 30                         Metformin is contraindicated.              Maximum daily dose is 25 mg.