Expiration date: 02/2025
Composition and form of issue:
1 tablet contains methotrexate 2, 5 5 or 10 mg in polypropylene bottles of 50 PCs., in a box 1 bottle.
1 ml of solution for injection-10 mg in 1 or 5 ml bottles, 1 bottle in a box.
1 ml concentrate for the preparation of infusions-100 mg in bottles of 5, 10 or 50 ml, in a box 1 bottle.
Pharmacological action:
It is an antimetabolite-folic acid antagonist. Inhibits dihydrofolate reductase and inhibits the formation of tetrahydrofolate involved in the biosynthesis of nucleic acids (single-carbon fragment transfer).
Description of pharmacological action:
Inhibits mitosis, the growth of actively proliferating tissues (including bone marrow), inhibits the progression of tumors.
Indications:
Acute lymphocytic leukemia, lymphogranulomatosis, head and neck cancer (squamous), lung, breast tumors of the testicle and ovary chorionepithelioma, soft tissue sarcoma, osteosarcoma, Ewing's sarcoma retinoblastoma trophoblastic disease (mono - and combination therapy), autoimmune diseases, psoriasis (refractive to other types of treatment).
Contraindications:
Hypersensitivity, impaired liver and kidney function bone marrow hypoplasia, leukopenia, thrombocytopenia, anemia infectious diseases ulcers in the mouth and gastrointestinal tract, postoperative conditions, pregnancy, breast-feeding.
Use during pregnancy and breast-feeding:
Contraindicated. At the time of treatment should stop breastfeeding.
Side effect:
Nausea, vomiting, difficulty swallowing, gingivitis, stomatitis, ulceration of the mucous membranes of the gastrointestinal tract, hemorrhages and other disorders of the digestive system and liver function tests, myelosuppression, immunosuppression, disorders of the urogenital system (urinary incontinence, electrolyte balance, reproductive functions) skin manifestations (erythema, alopecia, acne, etc.) headache, convulsions and other signs of CNS lesions, allergic reactions.
Dosage and administration:
Inside, the food with liquid, squeezed water in/m,/in (bolus, infusion) and intrathecal (subarachnoid). Doses are selected individually, depending on the disease, the General condition and blood picture of the patient. Doses above 100 mg / m2 body surface is administered only in / drip (solution or concentrate previously diluted 5% glucose solution to 10 mg (500-1000 ml) and under the protection of calcium folinate. Intrathecal-0, 2-0, 5 mg/kg (8-12 mg / m2 ) every 2-3 days after the disappearance (or reduction) of symptoms, the interval between injections increases to 1 week, then — up to 1 month prophylactically — every 6-8 weeks. In psoriasis, psoriatic arthritis, autoimmune diseases-10-25 mg inside, weekly (possibly also in/in or/m administration in the same dose) initial dose — 2, 5-5 mg, then the dose is increased to 7, 5-25 mg/week (not more than 30 mg/week).
Precautionary measures:
It is necessary to control the state of the oral mucosa, liver and kidney function, peripheral blood.
