Methotrexate Remedica

Breast cancer & gestational choriocarcinoma. Patients w/ chorioadenoma destruens & hydatidiform mole. In combination w/ other chemotherapeutic agents for palliative treatment of acute leukaemias particularly acute lymphoblastic leukaemia. Burkitt's lymphoma, advanced stages (III & IV, Peters Staging System) of lymphosarcoma especially in childn; advanced cases of mycosis fungoides. Monotherapy or in combination therapy in high dose schedules for epidermoid cancers of head & neck, osteogenic sarcoma & bronchogenic carcinoma; Ca folinate must be used in conjunction w/ high dose MTX. Symptomatic control of severe, recalcitrant, disabling psoriasis which is inadequately responsive to other forms of treatment. Severe, recalcitrant, active RA in adults unresponsive to or intolerant of adequate trial of NSAIDs & ≥1 disease-modifying drugs.

Trophoblastic disease 15-30 mg daily for a 5-day course. Leukemia Induction of remission of lymphoblastic leukemias: 3.3 mg/m² in combination w/ prednisolone 60 mg/m² daily. Maintenance: 30 mg/m² wkly. Burkitt's lymphoma Stage I or II: 10-25 mg daily for 4-8 days. Stage III: Concomitantly given w/ other antineoplastic agents. May respond to combined drug therapy w/ MTX 0.625-2.5 mg/kg daily. Mycosis fungoides 2.5-10 mg daily. High-dosage therapy: Psoriasis chemotherapy Adult weighing 70 kg Single test dose: 5-10 mg 1 wk prior to therapy initiation. Wkly single oral dose schedule: 10-25 mg/wk until adequate response is achieved. Max: 50 mg wkly. Divided oral dose schedule: 2.5 mg at 12-hr intervals for 3 doses or at 8-hr intervals for 4 doses each wk. Max: 30 mg wkly. Daily dose schedule: 2.5 mg daily for 5 days followed by a rest period of at least 2 days. Max: 6.25 mg daily. Rheumatoid arthritis chemotherapy Initially single dose of 7.5 mg once wkly or divided doses of 2.5 mg at 12-hr intervals for 3 doses given as a course once wkly. May increase dose in each schedule to 15 mg/wk after 6 wk in non-responsive patients. Max: 20 mg wkly.

Should be taken on an empty stomach.

Hypersensitivity. Patients w/ poor nutritional status, bone marrow depression, hepatic disorders or those w/ pre-existing blood dyscrasias (eg, bone marrow hypoplasia, leucopenia, thrombocytopenia or anaemia). Patients w/ overt or lab evidence of immunodeficiency syndrome(s). RA patients w/ active, infectious disease. Psoriasis patients w/ serious infections. Psoriasis & RA patients w/ PUD or ulcerative colitis; severe renal disorders, alcoholism or hepatic disorders including alcoholic liver disease or other chronic liver disease. RT to CNS should not be given concurrently w/ intrathecal MTX. Combination w/ etretinate & acitretin. Severe renal impairment. Pregnancy & lactation.

Cytotoxic Chemotherapy / Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

L04AX03 - methotrexate ; Belongs to the class of other immunosuppressants.

POM