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METHOTREXAT EBEWE

Package(a):
VIAL: 1 x 5 ml x 50 mg.
Dosage(a):
I.M./I.V. according to the indication, general condition and the blood counts.
Prescribing Restrictions:         

Package(b):
VIAL: 1 x 5 ml x 500 mg.
Dosage(b):
I.M./I.V. according to the indication, general condition and the blood counts.
Prescribing Restrictions:        

Package(c):
VIAL: 1 x 5 ml x 1,000 mg.
Dosage(c):
I.M./I.V. according to the indication, general condition and the blood counts.
Prescribing Restrictions:         

Package(d):
VIAL: 1 x 5 ml x 5,000 mg.
Dosage(d):
I.M./I.V. according to the indication, general condition and the blood counts.
Prescribing Restrictions:         

Package(e):
TABLETS: 50 x 2.5 mg.
Dosage(e):
1 tablet 3 x per week, one hour before meals or 1½-2 hours after meals.
Prescribing Restrictions:          

Package(f):
PRE-FILLED SYRINGE: 1 x 7.5 mg/0.75 ml.
Dosage(f):
I.M./I.V./S.C. according to the indication, general condition and the blood counts.
Prescribing Restrictions:  None

Package(g):
PRE-FILLED SYRINGE: 1 x 10 mg/1 ml.
Dosage(g):
I.M./I.V./S.C. according to the indication, general condition and the blood counts.
Prescribing Restrictions:  None

Package(h):
PRE-FILLED SYRINGE: 1 x 15 mg/1.5 ml.
Dosage(h):
I.M./I.V./S.C. according to the indication, general condition and the blood counts.
Prescribing Restrictions:  None

Package(i):
PRE-FILLED SYRINGE: 1 x 20 mg/2 ml.
Dosage(i):
I.M./I.V./S.C. according to the indication, general condition and the blood counts.
Prescribing Restrictions:  None


Indications:
Neoplastic disease, psoriasis and rheumatic arthritis, which are not adequately responsive to other forms of therapy.
Contra-Indications:
Hypersensitivity, pregnancy and lactation, alcoholism, severe hepatic and renal impairment, existing infections, diseases of the hematopoetic system. Ulcer of the oral cavity and GI tract, fresh surgical wounds.
Special Precautions:
Should be administered only under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Consumption of alcohol, even in low doses should be avoided. Plasma concentration of methotrexate: Higher than 1-2 times 10⁵ mol/L (24 hours after initiating therapy); twice 10⁶ mol/L (48 hours after initiating therapy); 10⁷ mol/L (72 hours after initiating therapy) indicate an increased risk and require a long-lasting and high dose of calcium folinate rescue therapy. In patients with impaired renal functions, dosage has to be reduced accordingly. In the case of high dose of methotrexate the creatinine clearance should be at least 75% of the normal value (50 ml/min/m² resp. 90 ml/min). An intermediate dose (>100 mg/m²) should not be prescribed if the creatinine clearance is reduced below 50% of the normal value unless daily determination of serum creatinine, methotrexate levels and calcium folinate rescue performed, till methotrexate levels decrease below 10⁷ moL. During the conventional dose, a dose reduction of 50% is recommended if the serum creatinine values are 1.2-2 mg/dl and cessation of therapy is recommended if serum creatinine values exceed 2 mg/dl. 
Prerequisites for medium or high?ose administration: Adequate availability of calcium folinate for subsequent rescue therapy; rapid determination of methotrexate serum levels; availability of hemodialysis; autologus bone marrow or blood supplies, leukocytes and platelet concentrates. Pretreatment examinations and safety precautions: Exclusion of renal and liver impairment and disturbances of the hemopoietic system; before treatment of rheumatoid arthritis in patients with hepatic disease, a liver biopsy should be performed; pregnancy should be excluded. See prescribing information for full details.
Side Effects:
The major toxic effects occur in normal, rapidly proliferating tissues, particularly bone marrow and the GI tract. Ulcerations of the oral mucosa are usually the earliest sign of toxicity. Difficulty in swallowing, ulcerative stomatitis, pharyngitis, leucopenia, thrombocytopenia, nausea, vomiting and abdominal distress.
Drug Interactions:
Activity is increased by: NSAID's, salicylates, sulphonamides, probenecid, cephalothin, penicillin, carbenicillin, ticarcillin, para-aminohippuric acid. Drugs involved in active tubular secretion, amidopyrine, epipodophyllotoxins. 
Activity is decreased by: corticosteroids, L-asparaginase, bleomycin, penicillin, allopurinol, vitamin preparations which contain folic acid or its derivatives (especially folinic acid). Drugs with known hepatotoxicity. Drugs with folic acid antagonist activity (pyrimethamine, trimethoprim) may increase the toxicity. See prescribing information for full details.