Methotrexate Sandoz

Methotrexate Sandoz





Firma Vai Hong
Concise Prescribing Info
Severe forms of active RA or chronic polyarthritis if therapy w/ other basic therapeutics or NSAIDs is not sufficiently effective or is not tolerated; or if it takes a particularly aggressive (malignant) course right from the beginning. Polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA) in childn ≥3 yr & adolescents when the response to NSAIDs has been inadequate. Most severe forms of psoriasis & psoriasis affecting the joints, which cannot be sufficiently treated w/ conventional therapy. Malignant trophoblastic tumours. Acute lymphocytic leukaemia (ALL).
Dosage/Direction for Use
RA 7.5 mg once wkly, may also be divided into 3 single doses to be taken once wkly at intervals of 12 hrly. Max: 20 mg wkly. Childn & adolescents w/ polyarthritic form of JIA 10-15 mg/m2/wk. Severe forms of psoriasis Single oral test dose of 2.5-5 mg to be continued 1 wk later w/ approx 7.5 mg. Max: 30 mg wkly. Tumour therapy Methotrexate 100 mg/m2 as single dose followed by Ca folinate. Malignant trophoblastic tumours 15 mg/m2 1-5 days, to be repeated after 3 wk. Acute lymphocytic leukamia 20-40 mg/m2 as single dose.
Should be taken on an empty stomach: Take at the same day each wk, preferably in the evening. Swallow whole w/ water, do not chew. Do not take w/ milk products.
Hypersensitivity. Severe or active infections; stomatitis, GI ulcers; sever liver dysfunctions; sever kidney dysfunctions (CrCl <60 mL/min); haematopoietic system dysfunctions; immunodeficiency; alcoholism. Pregnancy & lactation.
Special Precautions
Avoid contact w/ skin & mucous membranes. Avoid alcohol & liver-damaging agents. IDDM. Impaired lung function. Discontinue if suspected lung complications occur. Possibility of Pneumocystis carinii pneumonia. Pathological accumulations of liqd in body cavities should be evacuated by puncture prior to therapy. Avoid vaccination w/ live vaccines. May falsify vaccination & test results due to its possible effect on the immune system. Dehydration may increase toxicity of methotrexate due to elevated agent levels. Prior to treatment perform/evaluate CBC, liver values, blood protein, kidney values, hepatitis serology, exclusion of TB, thoracic x-ray. Therapy should be interrupted if ulcerative stomatitis or diarrhoea, vomiting blood, black discoloration of the stool or blood in stool occur. Tumour lysis syndrome. In longer-term therapy, bone marrow biopsies should be carried out if necessary. Concomitant administration w/ NSAIDs. Acute hepatitis; hepatotoxicity; leukoencephalopathy; acute neurological syndrome. Florid infectious disease. Leukopenia, thrombopenia and megaloblastic anaemia. Urinalysis should be made at regular intervals. Impaired renal function. Monitor urinary excretion & pH value of the urine during infusion. Oral cavity & pharynx should be inspected daily for mucosal changes. Men should avoid fathering a child during treatment & for up to 6 mth afterwards. Childn. Elderly.
Adverse Reactions
Thrombopenia, leukopenia, stomatitis, abdominal pain, anorexia, nausea & vomiting (mainly w/in the first 24-48 hr after administration), lowered CrCl as well as an increase in liver enzymes, alkaline phosphatase & bilirubin.
Drug Interactions
Increased hepatotoxicity during regular alcohol consumption or intake of liver-damaging medicines eg, azathioprine, leflunomide, retinoids. Increased toxicity w/ amidopyrine derivatives, para-aminobenzoic acid, barbiturates, doxorubicin, OCs, phenylbutazone, phenytoin, probenecid, salicylates, sulphonamides, tetracyclines & tranquillizers. Reduction in tubular secretion w/ para-aminohippuric acid, NSAIDs, probenecid, salicylates, sulphonamides & other weak organic acids. Increased serum conc w/ penicillins & sulphonamides. May impair efficacy in concomitant administration w/ vit preparations which contains folic acid or its derivatives. Increased plasma levels of mercaptopurines. May reduce the excretion of theophylline. Reduced absorption w/ oral antibiotics. Severe haematological & GI toxicity in concomitant administration w/ NSAIDs. Enhanced efficacy w/ sulfasalazine. Potentiated effect on folic acid metabolism w/ nitrogen monoxide base. Inhibited effect w/ L-asparaginase. Increased non-renal elimination w/ colestyramine. Pancytopenia w/ pyrimethamine or co-trimoxazole. Increased risk of impaired kidney function w/ procarbazine. Delayed or inhibited renal excretion w/ proton pump inhibitors (omeprazole, pantoprazole, lansoprazole). Increased risk of soft tissue or bone necrosis w/ radiotherapy. Increased nephrotoxicity w/ cisplatin.
ATC Classification
L04AX03 - methotrexate ; Belongs to the class of other immunosuppressants.
Methotrexate Sandoz tab 2.5 mg
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