Methotrexat-Ebewe

Methotrexat-Ebewe

methotrexate

Manufacturer:

Sandoz

Distributor:

Zuellig
/
Firma Vai Hong
Concise Prescribing Info
Contents
Methotrexate
Indications/Uses
Tab Severe cases of uncontrolled psoriasis unresponsive to conventional therapy. Treatment of adult w/ severe, active, classical or definite RA unresponsive or intolerant to conventional therapy. Acute lymphocytic & meningeal leukaemia, non-Hodgkin's lymphoma, carcinoma of the head & neck, ovary, bladder, cervix, stomach, large bowel, testis, breast, osteosarcoma, choriocarcinoma, trophoblasctic tumours, bronchogenic & urethral carcinoma & tumours in the CNS. 100 mg/mL Inj Acute lymphoblastic leukaemia, non-Hodgkin's lymphomas, leukaemic infiltration of meninges; CNS tumours, small cell lung carcinoma, lung carcinoma, testicular tumours, breast carcinoma, choriocarcinoma, cervical carcinoma, advanced urothelial cell & gastric carcinoma.
Dosage/Direction for Use
Tab Adult Psoriasis, psoriatic arthritis & autoimmunopathies 7.5-15 mg once wkly. Severe, acute, classical or definite RA 7.5 mg once wkly. Max dose: 15 mg wkly. Malignant tumors & haemoblastoses Individualized dosage. Inj Given IV, by infusion, IM, intra-arterially & intrathecally. Systemic Individualized dosage. Conventional therapy (Ca folinate rescue unnecessary) 15-20 mg/m2 IV twice wkly or 30-50 mg/m2 IV once wkly or 15 mg/m2/day IV/IM for 5 days. To be repeated after 2-3 wk. Intermediate-dose therapy 50-150 mg/m2 IV inj repeated after 2-3 wk (Ca folinate rescue unnecessary). 240 mg/m2 IV infusion over 24 hr repeated after 4-7 days (Ca folinate rescue necessary). 0.5-1 g/m2 IV infusion over 36-42 hr repeated after 2-3 wk (Ca folinate rescue necessary). High-dose therapy (Ca folinate rescue necessary) 1-12 g/m2 IV for 1-6 hr repeated after 1-3 wk. Intrathecal 0.2-0.5 mg/kg body wt or 8-12 mg/m2 body surface every 2-3 days; after the symptoms have subsided, at wkly, later at mthly intervals until the CSF findings are normal. A prophylactic intrathecal instillation should be given every 6-8 wk. Intrathecal/intraventricular Max of 15 mg/m2. Prior to administration, 100 mg/mL conc has to be diluted w/ standard infusion soln.
Administration
Should be taken on an empty stomach: May be taken w/ meals to reduce GI discomfort.
Contraindications
Hypersensitivity. Pregnancy & lactation. Diseases of the hematopoietic systems. Severe hepatic & renal impairment, infectious disease, oral cavity & GIT ulcers. Recent operation wounds. Alcoholism. Blood dyscrasias.
Special Precautions
Infection, peptic ulcer, ulcerative colitis, debility & extreme youth & old age, liver & kidney dysfunction. Reduced bone marrow function ascites or pleural effusion. Regular monitoring of white cell & platelet count. Leukopaenia, leukaemia. Urine pH <7.
Adverse Reactions
Ulcerative stomatitis, leukopenia, thrombocytopenia, nausea, abdominal distress, vomiting, dysphagia, pharyngitis, myelosuppression, mucositis.
Drug Interactions
Folinic acid. Salicylates, phenytoin, barbiturates, sulfonamides, corticosteroids, tetracyclines, chloramphenicol, PABA, p-aminohippuric acid or probenecid. NSAIDs, cephalotin, penicillins, carbenicillin, ticarcillin, sulfisoxazole, sulphurazole, doxorubicin, bleomycin, cyclophosphamide, phenazone & pyrazole derivatives, tranquillizers, oral antidiabetics, diuretics, vinca alkaloids, epipodophyllotoxins, L-asparaginase, triamterene, allopurinol, trimethoprim, indomethacin, diphenylhydantoin, acenocoumarol, phenprocoumon, vaccines. L-asparaginase, bleomycin, acyclovir. PPIs (eg, omeprazole, esomeprazole & pantoprazole).
ATC Classification
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.
Presentation/Packing
Form
Methotrexat-Ebewe inj 500 mg/5 mL
Packing/Price
1's
Form
Methotrexat-Ebewe inj 50 mg/5 mL
Packing/Price
1's
Form
Methotrexat-Ebewe inj 1000 mg/10 mL
Packing/Price
1's
Form
Methotrexat-Ebewe inj 5000 mg/50 mL
Packing/Price
1's
Form
Methotrexat-Ebewe tab 2.5 mg
Packing/Price
50's
Form
Methotrexat-Ebewe inj 10 mg/mL
Packing/Price
(vial) 1's
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