To lower your risk, drink plenty of fluids unless your doctor directs you otherwise. Also, your doctor may prescribe an additional medication. When this medication is used with radiation treatment, it may rarely increase the risk of tissue and bone damage. Discuss the risks and benefits of your treatment with your doctor. Doses vary considerably and will depend on the underlying disease. It is possible that you will only get methotrexate. In the case of cancer, it is also possible that you will receive so-called combination therapy in which you must take several medications.

Your body weight, age, general condition of health, your response to the drug and whether other medicines are required at the same time will also influence the dose you receive. Methotrexate has the potential for serious, sometimes fatal toxicity. Because the toxic reactions can occur at any time during therapy, your doctor should observe you closely and must inform you of early signs and symptoms of toxicity.

To be taken into consideration by patients on a low sodium diet. It may also be given by infusion drip into a vein. It may be diluted before it is given. Your doctor will work out the correct dose of Methotrexate Injection for you and how often it must be given.

Pulmonary symptoms especially a dry, nonproductive cough may require interruption of treatment and careful investigation. Diarrhea and ulcerative stomatitis require interruption of therapy: Malignant lymphomas, which may regress following withdrawal of methotrexate, may occur in patients receiving low-dose methotrexate and, thus, may not require cytotoxic treatment. Discontinue methotrexate first and, if the lymphoma does not regress, appropriate treatment should be instituted.

Like other cytotoxic drugs, methotrexate may induce "tumor lysis syndrome" in patients with rapidly growing tumors. Appropriate supportive and pharmacologic measures may prevent or alleviate this complication. Severe, occasionally fatal, skin reactions have been reported following single or multiple doses of methotrexate. Reactions have occurred within days of oral, intramuscular, intravenous, or intrathecal methotrexate administration. Recovery has been reported with discontinuation of therapy.

Potentially fatal opportunistic infections, especially pneumonia, may occur with methotrexate therapy. Methotrexate given concomitantly with radiotherapy may increase the risk of soft tissue necrosis and osteonecrosis.

Chemically methotrexate is N-[4-[[ 2,4-diaminopteridinyl methyl]methylamino] benzoyl]-L-glutamic acid. The structural formula is: Only the preservative free formulation of Methotrexate Injection, USP may be administered by the intrathecal route. 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.

The mechanism of action in rheumatoid arthritis is unknown; it may affect immune function. Two reports describe in vitro methotrexate inhibition of DNA precursor uptake by stimulated mononuclear cells, and another describes in animal polyarthritis partial correction by methotrexate of spleen cell hyporesponsiveness and suppressed IL 2 production.

Other laboratories, however, have been unable to demonstrate similar effects. In patients with rheumatoid arthritis, effects of methotrexate on articular swelling and tenderness can be seen as early as 3 to 6 weeks. Although methotrexate clearly ameliorates symptoms of inflammation pain, swelling, stiffness , there is no evidence that it induces remission of rheumatoid arthritis nor has a beneficial effect been demonstrated on bone erosions and other radiologic changes which result in impaired joint use, functional disability, and deformity.

Most studies of methotrexate in patients with rheumatoid arthritis are relatively short term 3 to 6 months. Limited data from long-term studies indicate that an initial clinical improvement is maintained for at least two years with continued therapy. In psoriasis, the rate of production of epithelial cells in the skin is greatly increased over normal skin.

This differential in proliferation rates is the basis for the use of methotrexate to control the psoriatic process. Methotrexate in high doses, followed by leucovorin rescue, is used as a part of the treatment of patients with non-metastatic osteosarcoma.

The original rationale for high dose methotrexate therapy was based on the concept of selective rescue of normal tissues by leucovorin. More recent evidence suggests that high dose methotrexate may also overcome methotrexate resistance caused by impaired active transport, decreased affinity of dihydrofolic acid reductase for methotrexate, increased levels of dihydrofolic acid reductase resulting from gene amplification, or decreased polyglutamation of methotrexate.

The actual mechanism of action is unknown. In a 6-month double-blind, placebo-controlled trial of pediatric patients with juvenile rheumatoid arthritis JRA mean age, The overwhelming majority of the remaining patients had systemic-course JRA. All patients were unresponsive to NSAIDs; approximately one-third were using low dose corticosteroids. Two Pediatric Oncology Group studies one randomized and one non-randomized demonstrated a significant improvement in relapse-free survival in patients with nonmetastatic osteosarcoma, when high dose methotrexate with leucovorin rescue was used in combination with other chemotherapeutic agents following surgical resection of the primary tumor.

However, a contribution can be inferred from the reports of objective responses to this therapy in patients with metastatic osteosarcoma, and from reports of extensive tumor necrosis following preoperative administration of this therapy to patients with non-metastatic osteosarcoma. Pharmacokinetics Absorption In adults, oral absorption appears to be dose dependent. Peak serum levels are reached within one to two hours. A twenty fold difference between highest and lowest peak levels Cmax: Significant interindividual variability has also been noted in time to peak concentration Tmax: Food has been shown to delay absorption and reduce peak concentration.

Methotrexate is generally completely absorbed from parenteral routes of injection. After intramuscular injection, peak serum concentrations occur in 30 to 60 minutes. As in leukemic pediatric patients, a wide interindividual variability in the plasma concentrations of methotrexate has been reported in pediatric patients with JRA. Following oral administration of methotrexate in doses of 6. In pediatric patients receiving methotrexate for acute lymphocytic leukemia 6. Distribution After intravenous administration, the initial volume of distribution is approximately 0.

Methotrexate has been used with beneficial effect in a wide variety of neoplastic diseases, alone and in combination with other cytotoxic agents. Choriocarcinoma and Similar Trophoblastic Diseases Methotrexate is administered orally or intramuscularly in doses of mg daily for a 5 day course. Such courses may be repeated times as required, with rest periods of one or more weeks interposed between courses until any manifesting toxic symptoms subside.

The effectiveness of therapy can be evaluated by 24 hours quantitative analysis of urinary chorionic gonadotrophin hormone HCG. Combination therapy with other cytotoxic drugs, has also been reported as useful. Hydatidiform mole may precede or be followed by choriocarcinoma, and methotrexate has been used in similar doses for the treatment of hydatidiform mole and chorioadenoma destruens.

Breast Carcinoma Prolonged cyclic combination with cyclophosphamide, methotrexate and fluorouracil has given good results when used as adjuvant treatment to radical mastectomy in primary breast cancer with positive axillary lymph nodes. Leukaemia Acute granulocytic leukaemia is rare in children but common in adults and this form of leukaemia responds poorly to chemotherapy.

Methotrexate is not generally a drug of choice for induction of remission of lymphoblastic leukaemia. Oral methotrexate dosage 3.

Twice weekly doses appear to be more effective than daily drug administration. Meningeal Leukaemia Some patients with leukaemia are subject to leukaemic invasions of the central nervous system and the CSF should be examined in all leukaemia patients. Passage of methotrexate from blood to the cerebrospinal fluid is minimal and for adequate therapy the drug should be administered intrathecally.

Methotrexate may be given in a prophylactic regimen in all cases of lymphocytic leukaemia. The dose of intrathecal Methotrexate is constant regardless of age or body surface area in patients over the age of 3 years of age, the maximum intrathecal dose should be 12 mg in such patients. Patients under the age of 3 years should be treated in accordance with combination chemotherapy protocols. The administration is at weekly intervals and is usually repeated until the cell count of cerebrospinal fluid returns to normal.

At this point one additional dose is advised. Large doses may cause convulsions and untoward side effects may occur as with any intrathecal injection, and are commonly neurological in character. Lymphomas In Burkitt's Tumour, stages , methotrexate has prolonged remissions in some cases. Recommended dosage is mg per day orally for 4 to 8 days. In stage 3, methotrexate is commonly given concomitantly with other antitumour agents. Treatment in all stages usually consists of several courses of the drug interposed with 7 to 10 day rest periods, and in stage 3 they respond to combined drug therapy with methotrexate given in doses of 0.

Hodgkin's disease responds poorly to methotrexate and to most types of chemotherapy. Mycosis Fungoides Therapy with methotrexate appears to produce clinical remissions in one half of the cases treated. Recommended dosage is usually 2. Methotrexate has also been given intramuscularly in doses of 50 mg once weekly or 25 mg twice weekly.

Psoriasis Chemotherapy Cases of severe uncontrolled psoriasis, unresponsive to conventional therapy, have responded to weekly single, oral, intramuscular or intravenous doses of mg per week, and adjusted according to the patient's response. An initial test dose one week prior to initiation of therapy is recommended to detect any idiosyncrasy. A suggested dose range is mg.

An alternative dosage schedule consists of 2. A daily oral dosage schedule of 2 to 5 mg administered orally for 5 days followed by a rest period of at least 2 days may also be used. The daily dose should not exceed 6. The patient should be fully informed of the risks involved and the clinician should pay particular attention to the appearance of liver toxicity by carrying out liver function tests before starting methotrexate treatment, and repeating these at 2 to 4 month intervals during therapy.

The aim of therapy should be to reduce the dose to the lowest possible level with the longest possible rest period. The use of methotrexate may permit the return to conventional topical therapy which should be encouraged.

Use in the elderly Methotrexate should be used with extreme caution in elderly patients. A reduction in dosage should be considered. Patients with significantly impaired hepatic function Patients with pre-existing blood dyscrasias, such as significant marrow hypoplasia, leukopenia, thrombocytopenia or anaemia.

Patients with active infections. Patients with overt or laboratory evidence of immunodeficiency syndrome s. Methotrexate is contraindicated in pregnancy.

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