Metotrexat (methotrexate) tablets 5 mg. №50

Description

Metotrexat composition
active substance: methotrexate;
1 tablet contains 5 mg of methotrexate;
excipients: lactose monohydrate; corn starch; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate.

Dosage form
Tablets.

Pharmacological properties
This drug Metotrexat is included in the group of pharmaceutical antineoplastics used for the treatment of 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.
Able to disrupt the synthesis of thymidylic acid during metabolism. It 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 cell synthesis of proteins, RNA and DNA 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 for:

• maintenance therapy for acute lymphocytic leukemia;
• treating severe cases of vulgar psoriasis (especially plaque type)
• treating 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 for:

• significant violations of the liver and / or kidneys;
• alcoholism;
• disorders 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 should be used in children with acute lymphocytic leukemia (as maintenance therapy). It is not recommended for use in children under 3 years of age, as there is insufficient information on the effectiveness and safety of the drug for 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
The drug Metotrexat is taken orally, once a week, swallowed without chewing, on an empty stomach (60 minutes before eating) or one and a half hours after taking it.
The exact dosage is prescribed by the attending physician of his profile (oncology, dermatology, rheumatology).
The recommended dosage for psoriasis and rheumatoid arthritis is 7.5 mg, once a week or 3 times 2.5 mg, at intervals of 12 hours (with severe nausea).
The starting dose may be lower, and increased to the required step, by 2.5 mg per week.
The maximum weekly dosage of methotrexate is 20 mg.
Treatment response is 4-8 weeks. If there is no response after 8 weeks, then the treatment regimen should be revised. If the result is achieved, it is desirable to reduce the dosage to the minimum effective.
The duration of maintenance therapy can be up to 2 years. After refusing to take the pills, the symptoms of the disease can return after 1-2 months.

Overdose
An overdose of this drug can cause a reaction of the body in the form of violations 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:

• pericardial effusion, pericardial tamponade;
• inhibition of bone marrow function (leukopenia, thrombocytopenia, anemia, pancytopenia);
• drowsiness, headache, fatigue;
• encephalopathy, subacute myelopathy;
• visual disturbances, 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
The Metotrexat is able to retain its medicinal properties for 3 years from the date of manufacture.
Storage temperature should not exceed 25 ° C.