Methotrexate Pfizer

Methotrexate Pfizer





Zuellig Pharma
Concise Prescribing Info
Antineoplastic chemotherapy: Gestational choriocarcinoma, chorioadenoma destruens, hydatidiform mole. Palliation of acute lymphocytic leukemia, acute lymphoblastic (stem cell) leukemias in childn; treatment & prophylaxis of meningeal leukemia. In combination w/ other anticancer drugs for maintenance of induced remissions. Monotherapy or in combination w/ other anticancer agents for management of breast & lung cancer, epidermoid head & neck cancers. Advanced stages (III & IV, Peters Staging System) of lymphosarcoma & mycosis fungoides. Psoriasis chemotherapy: Symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy. RA.
Dosage/Direction for Use
Choriocarcinoma & similar trophoblastic diseases 15-30 mg daily for 5 days. Repeat 3-5 times as required w/ ≥1 wk rest between courses. Leukemia Maintenance: Twice wkly. Meningeal leukemia 2-5 days interval until CSF cell count normalizes. Burkitt's tumour, stages I-II 10-25 mg daily for 4-8 days. Lymphosarcomas, stage III 0.625-2.5 mg/kg daily in combination w/ other antitumor agents. Mycosis fungoides 2.5-10 mg daily for wk or mth. Psoriasis chemotherapy Wkly single dose schedule: 10-25 mg wkly. Not to exceed 50 mg wkly. Divided dose schedule: 2.5 mg at 12-hr intervals for 3 doses or at 8-hr intervals for 4 doses wkly. Not to exceed 30 mg wkly. Daily dose schedule: 2.5 mg daily for 5 days followed by at least 2-day rest period. Not to exceed 6.25 mg daily. RA 7.5-20 mg once wkly or 2.5-7.6 mg every 12 hr for 3 doses wkly. Not to exceed 20 mg wkly.
May be taken with or without food.
Hypersensitivity. Psoriasis or RA patients w/ alcoholism, alcoholic or other chronic liver disease, overt or lab evidence of immunodeficiency syndromes; preexisting blood dyscrasias eg, bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anemia. Severe renal impairment. Pregnancy & lactation.
Special Precautions
Discontinue use if vomiting, diarrhea or stomatitis, significant drop in blood cell counts occur. Increased risk of soft tissue necrosis & osteonecrosis. Tumor lysis syndrome in patients w/ rapidly growing tumors; SJS, TEN (Lyell's syndrome); reactivation of hepatitis B or worsening of hepatitis C infections; acute or chronic interstitial pneumonitis, pleural effusions & ascites; PUD or ulcerative colitis; malignant lymphomas; folate deficiency states; preexisting haematopoietic impairment, severe myelosuppression; active infection, potentially fatal opportunistic infections; leukoencephalopathy. May aggravate psoriasis lesions. Perform liver damage & function test prior to dosing; baseline assessment eg, CBC w/ differential & platelet count, hepatic enzymes, hepatitis B or C infection & renal function tests; chest X-ray. Monitor serum MTX level. High-dose & prolonged use. Avoid concomitant use w/ PPIs. Not recommended in immunization w/ live virus vaccines. May affect ability to drive & use machines. Renal impairment. Acute hepatitis & chronic (fibrosis & cirrhosis) hepatotoxicity. May impair fertility. Not recommended in women of childbearing potential w/ neoplastic diseases. Avoid use during pregnancy. Childn. Elderly.
Adverse Reactions
Ulcerative stomatitis, leukopenia, nausea, abdominal distress. Malaise, undue fatigue, chills & fever, dizziness, decreased resistance to infection; paresthesia.
Drug Interactions
Enhanced nephrotoxicity w/ cisplatin. Increased risk of severe neurological adverse events w/ IV cytarabine. Antagonized effect w/ L-asparaginase. Increased plasma levels of mercaptopurine. Elevated & prolonged serum levels w/ NSAIDs, salicylates. Increased adverse effects w/ gold, penicillamine, hydroxychloroquine, sulfasalazine. Elevated plasma levels w/ PPIs. Diminished renal tubular transport by ciprofloxacin, probenecid. Reduced renal clearance w/ penicillins & sulfonamides. Decreased intestinal absorption w/ oral antibiotics eg, tetracycline, chloramphenicol & nonabsorbable broad-spectrum antibiotics. Increased bone marrow suppression w/ trimethoprim/sulfamethoxazole. Increased toxic effects w/ antiprotozoal pyrimethamine. Increased risk of hepatotoxicity w/ other hepatotoxic agents eg, leflunomide, azathioprine, sulfasalazine, retinoids. Potentiated effect on folate metabolism w/ nitrous oxide anesth. Decreased response w/ folic acid-containing vit. Induced ulcerated skin lesions w/ amiodarone. Increased toxicity w/ sulfonylureas, aminobenzoic acid, salicylates, phenylbutazone, phenytoin, sulfonamides & some antibiotics eg, penicillins, tetracycline, pristinamycin, probenecid, chloramphenicol. Increased risk of pancytopenia w/ leflunomide. Skin cancer w/ psoralen + PUVA therapy. Decreased clearance of theophylline. Bone marrow suppression & decreased folate levels w/ triamterene.
MIMS Class
Cytotoxic Chemotherapy / Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
ATC Classification
L04AX03 - methotrexate ; Belongs to the class of other immunosuppressants.
Methotrexate Pfizer tab 2.5 mg
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