Tab: Severe cases of uncontrolled psoriasis unresponsive to conventional therapy. Treatment of adults w/ severe, active, classical or definite RA who are unresponsive or intolerant to conventional therapy. Used to produce regression in neoplastic conditions including acute lymphocytic leukaemia (ALL), meningeal leukaemia, non-Hodgkin's lymphoma, carcinoma of the head & neck, ovary, bladder, cervix, stomach, large bowel, testis, breast, osteosarcoma, choriocarcinoma & other trophoblastic tumours, bronchogenic & urothelial carcinoma & tumours in the CNS. Conc for soln for infusion: Malignant diseases eg, ALL, non-Hodgkin's lymphoma, breast cancer, choriocarcinoma.
Dosage/Direction for Use
TabAdultPsoriasis 7.5-15 mg once wkly. Severe, acute, classical or definite RA 7.5 mg once wkly. Max dose: 15 mg wkly. Adult & childnNeoplasia Individualized dosage based on patient's body wt or surface area. Conc for soln for infusion Dosage schedules vary considerably depending on the clinical use. Large doses (>100 mg) are usually given by IV infusion over periods not exceeding 24 hr. Intrathecal/intraventricular administration Max dose: 15 mg. Max conc: 5 mg/mL.
Administration
Should be taken on an empty stomach: May be taken w/ meals to reduce GI discomfort.
Contraindications
Hypersensitivity. Blood dyscrasias including hypoplasia of the bone marrow, leucopenia, thrombocytopenia, anaemia. Significant renal or hepatic dysfunction. Pregnancy & lactation. Conc for soln for infusion: Active infectious disease, evidence of immuno-deficiency syndrome, general poor condition.
Special Precautions
Caution in patients w/ haematological depression, renal impairment, peptic ulcer, ulcerative colitis, ulcerative stomatitis, diarrhoea, debility & in young childn & the elderly. Patients w/ pleural effusions or ascites should have these drained if appropriate before treatment or treatment should be withdrawn. Interrupt therapy in case of symptoms of GI toxicity. Immunosuppressive activity; may decrease immunological response to concurrent vaccination. Risk of severe antigenic reaction w/ concomitant live vaccine. Treatment should not be instituted or should be discontinued in case of any abnormality in LFTs or liver biopsy. Potential for MTX-induced adverse effects in the pulmonary system in RA patients. Haemopoietic suppression; immediately w/draw MTX in case of any profound drop in WBC or platelet counts. High doses may cause precipitation of MTX or its metabolites in the renal tubules. Assess renal function, liver function & blood elements before therapy or reinstituting MTX after a rest period. Perform the following lab tests during treatment: Complete haematological analysis, urinalysis, renal function tests, LFTs & when high doses are administered, determination of plasma levels of MTX. Reports of serious adverse reactions including deaths w/ MTX (usually in high doses) & concomitant NSAIDs. Reports of acute megaloblastic pancytopenia (rare) w/ folate antagonists eg, trimethoprim/sulphamethoxazole. May impair ability to drive or operate machinery. Reports of impairment of fertility, oligospermia, menstrual dysfunction & amenorrhoea during & for a short period after cessation of therapy. Risk of embryotoxicity, abortion & foetal defects. Not recommended in women of childbearing potential. Avoid conception for at least 6 mth after treatment discontinuation.
Adverse Reactions
Ulcerative stomatitis, leucopenia, nausea, abdominal distress. Eye irritation, malaise, undue fatigue, chills & fever, dizziness, loss of libido/impotence, decreased resistance to infection.
Protein bound MTX may be displaced by salicylates, sulphonamides, diuretics, oral hypoglycaemics, diphenylhydantoins, tetracyclines, chloramphenicol, sulfazole, doxorubicin, cyclophosphamide & barbiturates, leading to increased toxicity. Reduce dose of MTX when given concomitantly w/ probenecid. Increased intracellular MTX & MTX polyglutamates w/ vinca alkaloids. Potential altered response to MTX w/ vit prep or oral Fe prep containing folic acid. Impaired renal clearance w/ NSAIDs, leading to severe toxicity. Increased serum levels & severe hepatitis w/ etretinate. Potential elevated & prolonged serum levels of MTX &/or its metabolite hydroxymethotrexate w/ PPIs eg, omeprazole, esomeprazole, pantoprazole. Avoid concomitant use of drugs w/ nephrotoxic or hepatotoxic potential (including alcohol).
L01BA01 - methotrexate ; Belongs to the class of antimetabolites, folic acid analogues. Used in the treatment of cancer. L04AX03 - methotrexate ; Belongs to the class of other immunosuppressants.
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