Metotrexat-Teva solution for injections 25 mg/ml. 2 ml. №1 vial

Description

Metotrexat-Teva composition
active substance: methotrexate;
1 ml of solution contains methotrexate 25 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.
Methotrexate 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
Metotrexat is administered intramuscularly, intravenously, intraarterially, intrathecally, intraventricularly.
Sodium chloride is used as a solvent. The dosage is calculated individually, depending on the type of cancer, the patient’s body weight, and his condition.
The maximum single dose is 15 mg, the maximum concentration is 5 mg / ml.
In particular, when:

• leukemia – from 2.5 to 30 mg of the drug per 1 square meter of the patient’s skin surface;
• non-Hodgkin’s lymphoma – from 500 to 7500 mg per 1 square meter of body area;
• breast cancer – 40 mg per 1 square meter of the patient’s body surface;
• choriocarcinoma – 15-30 mg daily, for 5 days (courses, with a week break).

In case of renal or hepatic insufficiency, hematological problems, as well as in the treatment of patients over the age of 70, the dose is reduced by about 50% of the usual.
It can be used both as a mono-drug and in combination with other drugs.
Folinate is prescribed to protect healthy cells from the effects of methotrexate

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.