Methotrexate

The injection solution "Method" is indicated for: an active form of rheumatoid arthritis in adults; polyarthritic severe form of juvenile (idiopathic) arthritis in case of inadequate response to non-steroidal anti-inflammatory drugs; severe psoriasis, especially in the form of plaques, in case of failure of appropriate therapy, such as phototherapy, PUVA therapy and the use of retinoids, as well as in the case of severe psoriatic arthritis in adults.

Structure

1 ml of the solution contains 50 mg methotrexate (in the form of sodium methotrexate - 54.84 mg).

Excipients: sodium hydroxide, sodium chloride, water for injection.

Contraindications

• hypersensitivity to methotrexate or to any of the components;
• liver failure;
• alcohol abuse;
• severe renal failure (creatinine clearance less than 20 ml / minute);
• a history of blood diseases, such as bone marrow hypoplasia, leukopenia, thrombocytopenia, or severe anemia;
• severe acute or chronic infections, such as tuberculosis and HIV, or other immunodeficiency syndromes;
• ulcers in the oral cavity and peptic ulcers of the stomach or intestines in an active form;
• concomitant vaccination with live vaccines.

Mode of application

Only doctors who know all the features of this drug and its mechanism of action should prescribe methotrexate. The Metoject should be administered once a week.

The patient should be clearly informed that the drug should be administered 1 time per week. It is advisable to set a fixed day of the week as the day of injection.

This dosage form is for single use only.

Solution “Metoject” for injection can be administered intramuscularly, intravenously or subcutaneously (for children and adolescents only subcutaneous or intramuscular injections are used).

The duration of the course of treatment is determined by the doctor.

When changing oral administration to parenteral administration, a dose reduction of methotrexate may be required due to different bioavailability with different routes of administration.

The possibility of adding folic acid to the current treatment regimen may be considered.

Adult patients with rheumatoid arthritis.

The recommended starting dose is 7.5 mg methotrexate, which is administered subcutaneously, intramuscularly or intravenously once a week. Depending on the specific course of the disease and tolerability of the drug, the initial dose can be gradually increased by 2.5 mg per week. Do not exceed the maximum weekly dose of 25 mg. Also, doses exceeding 20 mg / week may be accompanied by a significant increase in toxicity, especially bone marrow depression. Typically, a response to treatment can be expected after about 4-8 weeks. After the therapeutic effect is achieved, the dose should be gradually reduced to the minimum effective maintenance dose.

Children under the age of 16 years, patients with polyarthritis form of juvenile (idiopathic) arthritis.

The recommended dose is 10-15 mg / m² body surface / week. In case of insufficient action, the weekly dose can be increased to 20 mg / m² body surface / week. Due to the lack of reliable information about intravenous administration of methotrexate in this group of patients, methotrexate should be administered subcutaneously or intramuscularly.

This group of patients should be treated under the supervision of a rheumatologist who has experience working with children and adolescents.

Patients with psoriasis vulgar and psoriatic arthritis.

It is recommended to administer a parenteral test dose of 5-10 mg one week before the start of treatment in order to identify idiosyncratic adverse reactions. The recommended starting dose is 7.5 mg methotrexate, administered subcutaneously, intramuscularly or intravenously once a week.The dose should be increased gradually, but the maximum weekly dose of methotrexate should not be exceeded 25 mg. Taking doses in excess of 20 mg / week may be accompanied by a significant increase in toxicity, especially bone marrow depression. Typically, a response to treatment can be expected after about 2-6 weeks. After the therapeutic effect is achieved, the dose should be reduced gradually to the lowest possible effective maintenance dose.

Application features

Pregnancy

Studies have shown the teratogenic effect of methotrexate (the drug caused fetal death and / or congenital malformations, especially when used in the first trimester of pregnancy), so it should not be used during pregnancy.

Reliable contraceptive methods should be used for men and women of reproductive age during treatment with methotrexate and for at least 6 months after treatment.

If the patient or partner of the man who is being treated with methotrexate nevertheless becomes pregnant, it is necessary to consult specialists regarding the risk of adverse effects of methotrexate on the fetus.

Methotrexate passes into breast milk in concentrations that pose a risk to the baby, so breast-feeding should be interrupted before and during treatment.

Thus, methotrexate is contraindicated during pregnancy or lactation.

Children

Children and adolescents use only subcutaneous or intramuscular injections.

Methotrexate is not recommended for use by children under 3 years of age due to the lack of sufficient information on efficacy and safety.

Drivers

During treatment with this solution, one should refrain from driving vehicles or working with mechanisms, since side effects from the nervous system (fatigue and dizziness) may occur.

Overdose

The toxicity of methotrexate is mainly directed to the hematopoietic system.

Side effects

The most significant adverse reactions are inhibition of blood formation and disorders of the gastrointestinal tract.

Storage conditions

Store the pre-filled syringe at a temperature not exceeding 25 ° C, out of the reach of children, in the original packaging to protect from light.

Shelf life is 2 years.