Methotrexat Ebewe

Methotrexat Ebewe

methotrexate

Manufacturer:

EBEWE Pharma

Distributor:

Maxxcare

Marketer:

Mega Lifesciences
Concise Prescribing Info
Contents
Methotrexate
Indications/Uses
Active RA in adults. Disseminated chronic psoriasis when other therapy has failed. Maintenance therapy in acute lymphatic leukaemia.
Dosage/Direction for Use
Psoriasis Initially 2.5 mg 3 times wkly w/ 12 hr interval. Alternatively, 7.5 mg as single dose once a wk. RA Initially 7.5 mg wkly as single dose. May be increased stepwise by 2.5 mg/wk if no response has been achieved after 6-8 wk. Max: 20 mg/wk. Acute lymphatic leukaemia Up to 30 mg/m2. Childn Maintenance treatment: Up to 20 mg/m2 wkly w/ IV administration & intrathecal CNS prophylaxis.
Administration
Should be taken on an empty stomach: Take 1 hr before or 90 min to 2 hr after a meal.
Contraindications
Hypersensitivity. Blood dyscrasias including hypoplasia of the bone marrow, leukopenia, thrombocytopenia, anaemia. Active infectious disease, immunodeficiency syndrome. Significant hepatic dysfunction including fibrosis, cirrhosis, or hepatitis. Significant renal dysfunction. General poor condition. Pregnancy & lactation.
Special Precautions
Discontinue if any abnormality in liver function tests or liver biopsy is present or develops. Immediately w/draw in case of any profound drop in white cell or platelet counts. GI toxicity; pleuropulmonary manifestation of RA. High doses may cause precipitation in renal tubules which may be prevented by high fluid intake & alkalinisation of urine. Patients w/ haematological depression, peptic ulcer, ulcerative colitis & stomatitis, diarrhoea debility. Drain pleural effusions or ascites prior to treatment. Assess renal & liver function & blood elements prior to therapy or reinstitution. Regularly perform complete haematological analysis, urinalysis, renal & liver function tests & determination of plasma levels (in high doses). May impair ability to drive a vehicle or operate machinery. Renal impairment. Avoid conception during & at least 3 mth after cessation of treatment. Not recommended in women of childbearing potential. Childn. Elderly.
Adverse Reactions
Headache, dizziness; leukopenia; nausea, vomiting, stomatitis, diarrhoea, anorexia; alopecia; significant elevation of liver enzymes; infection.
Drug Interactions
May decrease immunological response to concurrent vaccination. May cause severe antigenic reaction w/ live vaccine. May be displaced by salicylates, sulphonamides, diphenylhydantoins, tetracyclines, chloramphenicol, sulfazole, doxorubicin, cyclophosphamide & barbiturates leading to high plasma levels & increased toxicity. Increased plasma levels w/ other drugs subject to active renal secretion. Reduce dose when given concomitantly w/ probenecid. Intracellular conc may be increased w/ vinca alkaloids. Avoid concomitant use of drugs w/ nephrotoxic or hepatotoxic potential (including alcohol). Response may be altered w/ vit or oral Fe prep. Renal clearance may be impaired w/ NSAIDs. Serum levels may be increased by etretinate. Rare cases of acute pancytopenia w/ folate antagonists eg, trimethoprim/sulphamethoxazole.
ATC Classification
L04AX03 - methotrexate ; Belongs to the class of other immunosuppressants.
Presentation/Packing
Form
Methotrexat Ebewe tab 2.5 mg
Packing/Price
50's
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