Methotrexate-Teva solution for injection 25 mg/ml vial 2 ml No. 1

METHOTREXATE-TEVA contains methotrexate, which is a folic acid antagonist that competitively inhibits dehydrofolate reductase, an enzyme that converts folic acid to tetrahydrofolic acid. Inhibition of tetrahydrofolate formation limits the number of single-carbon fragments required for purine synthesis and the conversion of deoxyuridylate to thymidylate during DNA synthesis, which leads to inhibition of cell repair and reproduction.

Indication

Trophoblastic tumors (choriocarcinoma, chorioadenoma, vesicular drift), acute lymphoblastic leukemia, neuroleukemia, osteosarcoma, non-Hodgkin lymphoma, Burkitt lymphoma, advanced head and neck cancer, breast cancer, advanced stages of mycosis fungoides, severe forms of psoriasis, severe cases of rheumatoid arthritis.

Composition

Active ingredient: methotrexate.

1 ml of solution contains 25 mg of methotrexate.

Excipients: sodium hydroxide, sodium chloride, sodium hydroxide solution, diluted hydrochloric acid, water for injections.

Contraindication

Hypersensitivity to the components of the drug, pregnancy (when used for non-oncological indications) or breastfeeding, poor nutritional status, significant liver dysfunction (bilirubin level > 85.5 μmol/l), significant renal dysfunction (creatinine clearance < 20 ml/min), disorders of the hematopoietic system (in particular bone marrow hypoplasia, leukopenia, thrombocytopenia or severe anemia), alcohol abuse, pulmonary toxicity caused by the action of methotrexate, severe, acute or chronic infections (e.g. tuberculosis or AIDS), immunodeficiency syndrome (when used in patients with psoriasis or rheumatoid arthritis), stomatitis, ulcers of the oral mucosa or digestive tract, vaccination with live vaccines during methotrexate treatment.

Method of application

Doses and duration of treatment are set individually, depending on the chemotherapy regimen, indications, and tolerability of the drug. Treatment should be carried out by a physician who has experience in the use of methotrexate and understands the risks associated with the use of methotrexate.

Special instructions

Pregnancy

The use of methotrexate for non-oncological indications during pregnancy is contraindicated.

Children

The drug can be used in children with acute lymphocytic leukemia, neuroleukemia and non-Hodgkin lymphoma only as part of combination therapy. The use of the drug for the treatment of children under 3 years of age is not recommended, as there is no data on the effectiveness and safety of the therapy in this group of patients.

Drivers

Given that methotrexate can cause fatigue, drowsiness, dizziness, visual disturbances, paresis and hemiparesis, the drug has a mild to moderate adverse effect on the ability to drive or use machines.

Overdose

Symptoms of overdose are an increase in the severity of one or more adverse reactions. Toxic effects become more pronounced in patients receiving long-term therapy. Symptoms associated with suppression of the hematopoietic and digestive systems are observed mainly.

Side effects

The most significant side effects of methotrexate treatment are hematopoietic suppression and gastrointestinal adverse reactions. The most commonly reported adverse reactions were ulcerative stomatitis, leukopenia, nausea and gastric disorders. Other adverse reactions that were reported quite frequently included malaise, unusual fatigue, feeling of chills and heat, dizziness and decreased resistance to disease.

Interaction

Methotrexate should be combined with potentially hepatotoxic substances (such as alcohol, leflunomide, azathioprine, sulfasalazine, metamizole) with caution.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Shelf life - 2 years.