Methox Tablet 2.5 mg

Indications

Neoplastic Diseases:

Treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole

In acute lymphoblastic leukemia

Used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkin’s lymphomas

Treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T-cell lymphoma) and lung cancer, particularly squamous cell and small cell types.

Rheumatoid Arthritis including Polyarticular-Course Juvenile Rheumatoid Arthritis: Indicated in the management of selected adults with severe, active rheumatoid arthritis, or children with active polyarticular-course juvenile rheumatoid arthritis, who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs)

Psoriasis: Indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy.

Pharmacology

Methotrexate inhibits dihydrofolic acid reductase. Dihydrofolates must be reduced to tetrahydrofolates by this

enzyme before they can be utilized as carriers of one-carbon groups in the synthesis of purine nucleotides and thymidylate. Therefore, methotrexate interferes with DNA synthesis, repair, and cellular replication. Actively proliferating tissues such as malignant cells, bone marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder are in general more sensitive to this effect of methotrexate. When cellular proliferation in malignant tissues is greater than in most normal tissues, methotrexate may impair malignant growth without irreversible damage to normal tissues. In psoriasis, the rate of production of epithelial cells in the skin is greatly increased over normal skin. This difference in proliferation rates is the basis for the use of methotrexate to control the psoriatic process.

Dosage

Neoplastic Diseases-

Choriocarcinoma and similar trophoblastic diseases: Orally or intramuscularly in doses of 15 to 30 mg daily for a five-day course. The courses are usually repeated for 3 to 5 times as required, with rest periods of one or more weeks interposed between courses, until any manifesting toxic symptoms subside. Since hydatidiform mole may precede choriocarcinoma, prophylactic chemotherapy with methotrexate has been recommended. Chorioadenoma destruens is considered to be an invasive form of hydatidiform mole. Methotrexate is administered in these disease states in doses similar to those recommended for choriocarcinoma

Acute Lymphoblastic Leukemia

Induction dose: 3.3 mg/m2 in combination with prednisone 60 mg/m2 daily for 4 to 6 weeks

Maintenance dose: Orally or IM administration 2 times a week in total weekly doses of 30 mg/m2

Alternate maintenance dose: 2.5 mg/kg IV every 14 days. If and when relapse does occur, reinduction of remission can again usually be obtained by repeating the initial induction regimen

Lymphoma

Burkitt's tumor Stages I to II: 10 to 25 mg once a day for 4 to 8 days

Burkitt's tumor Stage III: Methotrexate is commonly given concomitantly with other antitumor agents

Duration of therapy: All stages usually require several courses of therapy interposed with 7 to 10 day rest periods

Lymphosarcoma Stage III: 0.625 to 2.5 mg/kg daily as a part of combination chemotherapy

Mycosis Fungoides: Early stage dosing: 5 to 50 mg once a week; alternatively, 15 to 37.5 mg 2 times a week may be used in patients who have responded poorly to weekly therapy

Breast Cancer: 40 mg/m 2 intravenously on the 1 st and 8 th day every 4 weeks in combination with cyclophosphamide and fluoracil for 6-12 cycles

Head and Neck Cancer: 40 mg/m2 IV weekly until disease progression or unacceptable toxicity (3 weeks equals one cycle; goal is to complete at least six cycles).

Adult Rheumatoid Arthritis: Single doses of 7.5 mg once per week, Maximum dose: 20 mg/week in adults

Polyarticular-Course Juvenile Rheumatoid Arthritis: 10 mg/m2 once weekly

Psoriasis: Single dose: 10 to 25 mg once per week, maximum dose: 30 mg/week

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Administration

Should be taken on an empty stomach. Best taken on an empty stomach. May be taken with meals to reduce GI discomfort. Avoid taking with milk-rich products.

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