Metotrexat solution for injections 10 mg/ml. 5 ml. vial №1

Description

Metotrexat composition
active substance: methotrexate;
1 ml of solution contains methotrexate 10 mg;
Excipients: sodium hydroxide, sodium chloride, sodium hydroxide solution, dilute hydrochloric acid, water for injections.

Dosage form
Solution for injection.

Pharmacological properties
This Metotrexat drug belongs to the group of pharmaceutical antineoplastic agents used to treat cancer.
Refers to antianginal, vasodilator, coronary dilator drugs. It is included in the group of analogue drugs (generics) of folic acid, which plays an important role in the functioning of various human systems and organs.
It has the property of inhibiting the processes in which dihydrofolic acid is converted to tetrahydrofolic acid.
It is capable of disrupting the synthesis of thymidylic acid during the metabolism. Also inhibits the production of purine. As a result, DNA synthesis is suppressed in the body. The process of cell reproduction, the synthesis of RNA, as well as proteins is disrupted.
The greatest effect of inhibition of the synthesis of proteins, RNA and DNA cells occurs in tumor tissues, including cancerous ones. Bone marrow tissues, epithelial cells, and cells of a gestating fetus are sensitive to the action of the drug.
Metotrexat also has immunosuppressive properties.

Indications
This drug, Metotrexat, is used to treat cancer. In particular, when treating:

• acute lymphocytic leukemia;
• non-Hodgkin’s lymphoma;
• breast cancer;
• choriocarcinoma;
• severe cases of psoriasis or rheumatoid arthritis.

Contraindications
You should not use the specified drug if the patient has had a previous hypersensitivity (allergy) with respect to one of the components that are part of the drug – both basic and auxiliary.
Also, use is contraindicated in:

• significant violations of the liver and / or kidneys;
• alcoholism;
• violations of the hematopoietic system (leukopenia, anemia, etc.);
• severe, acute or chronic infections (tuberculosis, HIV);
• ulcers of the oral cavity, gastrointestinal tract;
• vaccination with live vaccines during the treatment period.

Avoid eating foods / drinks containing tannin or caffeine.
Incompatible with oxidants and acids.

Children
The drug can be used in children with acute lymphocytic leukemia, neuroleukemia and non-Hodgkin’s 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 are no data on the effectiveness and safety of therapy in this group of patients.

Application during pregnancy and lactation
Treatment of pregnant women with this drug is contraindicated.
During treatment with this drug, breastfeeding should be suspended.

Method of administration and dosage

• Treatment of patients with rheumatoid arthritis and psoriasis
  Treatment with Metotrexat “Ebeve” should be carried out under the supervision of a rheumatologist or dermatologist, as well as a physician. The drug is administered subcutaneously, intramuscularly or intravenously.
• Doses for adults with rheumatoid arthritis
  The recommended starting dose is 7.5 mg methotrexate once a week subcutaneously, intramuscularly or intravenously.
  Usually the therapeutic effect is manifested after 4-6 weeks of therapy. If after 6-8 weeks of treatment there are no signs of improvement and no signs of toxic effects, the dose can be gradually increased by 2.5 mg per week. Usually the optimal weekly dose is 7.5-15 mg. The maximum dose should not exceed 25 mg per week. If after 8 weeks of treatment the maximum dose has no effect, methotrexate should be discontinued. If the desired therapeutic effect is achieved, treatment should be continued in the lowest possible effective maintenance dose. The optimal duration of methotrexate therapy has not yet been determined, but preliminary data suggest that the initial effect is maintained for at least 2 years if maintenance therapy is continued. After stopping treatment with methotrexate, the symptoms may return in 3-6 weeks.
• Doses for patients with psoriasis and psoriatic arthritis
  A trial parenteral administration of 5–10 mg of methotrexate 1 week before therapy is recommended to detect idiosyncratic side effects. The recommended starting dose is 7.5 mg methotrexate once a week subcutaneously, intramuscularly or intravenously. The dose can be increased gradually, but the maximum weekly dose of 30 mg methotrexate should not be exceeded. Usually the therapeutic effect is manifested after about 2-6 weeks of therapy. If the desired therapeutic effect is achieved, treatment should be continued in the lowest possible effective maintenance dose.
• Dosage for children under 16 years of age suffering from polyarthritis forms of juvenile idiopathic arthritis.
  The recommended dose is 10-15 mg / m2 of body surface area / week. In case of insufficient action, the weekly dose can be increased to 20 mg / m2 of body surface area / week.
  In juvenile idiopathic arthritis, the drug should be used only intramuscularly, as there are insufficient data on subcutaneous and intravenous use in children.

Overdose
An overdose of this drug can cause a reaction of the body in the form of disorders of the hematopoietic system.
Calcium folinate is recommended as an antidote, which has the property of neutralizing the toxic effects of methotrexate.

Side effects
Side effects can occur in the form:

• effusion in the pericardial cavity, pericardial tamponade;
• inhibition of bone marrow function (leukopenia, thrombocytopenia, anemia, pancytopenia);
• drowsiness, headache, fatigue;
• encephalopathy, subacute myelopathy;
• visual impairment, pain, myasthenia gravis, epileptic seizures, paralysis, ataxia, dementia, coma;
• eye irritation, cataracts, photophobia, conjunctivitis;
• pneumonitis, cough, shortness of breath, bronchial asthma, fever;
• epistaxis, alveolitis, pleural effusion;
• upset stomach, stomatitis, nausea, anorexia, dyspepsia;
• diarrhea, mouth ulcers;
• ulcers of the gastrointestinal tract, impaired renal function, impaired urination;
• exanthema, erythema, itching;
• alopecia, vasculitis, allergic urticaria;
• arthralgia, myalgia, osteoporosis;
• increasing susceptibility to infections;
• impairment of wound healing.

Storage conditions and periods
This Metotrexat medicinal product is able to maintain its medicinal properties for 2 years from the date of manufacture.
Storage temperature should not exceed 25 ° C.