Posology : מינונים

4.2. Posology and method of administration

Posology
Dosages are based on the patient's body weight or surface area. Doses should be reduced in cases of haematological deficiency and hepatic or renal impairment.
This medicine should only be taken once a week.

Important warning about the dosage of Methotrexate "Ebewe" 2.5 mg tablets: For the treatment of psoriasis, rheumatoid arthritis and for some of the hematological indications (as prescribed by the physician according to the treatment protocol), Methotrexate "Ebewe" 2.5 mg tablets must only be taken once a week.
Methotrexate "Ebewe" 2.5 mg tablets should not be taken daily. Daily dosage intake of Methotrexate "Ebewe" 2.5 mg tablets can result in serious adverse reactions and severe complications, including death. Please read this section of the summary of product characteristics very carefully.
Choose the most convenient day of the week to take Methotrexate "Ebewe" 2.5mg tablets. In order to remember on which day Methotrexate "Ebewe" 2.5mg tablets are taken, you should keep a tracking sheet.

Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy.

The prescriber should ensure that patients or their carers will be able to comply with the once weekly regimen.

The prescriber should specify the day of intake on the prescription.

Acute Lymphoblastic Leukaemia:
Paediatric population

In acute lymphoblastic leukaemia remissions are usually best induced with a combination of corticosteroids and other cytotoxic agents.

Methotrexate 15mg/m2, given orally once weekly, in combination with other drugs, appears to be the treatment of choice for maintenance of drug-induced remissions.

Burkitt's Lymphoma:

Paediatric population
Some cases of Burkitt's lymphoma, when treated in the early stages with courses of 15mg/m2 daily orally for five days, have shown prolonged remissions. Combination chemotherapy is also commonly used in all stages of the disease.

Psoriasis:

Adults
It is recommended that a test dose of 5-10mg should be administered, one week prior to therapy to detect idiosyncratic adverse reactions.

In most cases of severe uncontrolled psoriasis, unresponsive to conventional therapy, 10-25mg orally once a week and adjusted by the patient's response is recommended.

The use of methotrexate in psoriasis may permit the return to conventional topical therapy which should be encouraged.

Rheumatoid arthritis:

Adults
It is recommended that a test dose of 5-10mg should be administered, one week prior to therapy to detect idiosyncratic adverse reactions.

In adults with severe, acute, classical or definite rheumatoid arthritis who are unresponsive or intolerant to conventional therapy, 7.5mg orally once weekly. The schedule may be adjusted gradually to achieve an optimal response but should not exceed a total weekly dose of 20mg. Once response has been achieved, the schedule should be reduced to the lowest possible effective dose.

Elderly

Methotrexate should be used with extreme caution in elderly patients; a reduction in dosage should be considered (see 4.4).

Paediatric population

Safety and effectiveness in children have not been established, other than in cancer chemotherapy.
Method of administration

For oral administration.