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Active Ingredient: Methotrexate.

Active Ingredient: Methotrexate 2.5 mg

Release form, composition and packaging
Coated tablets 1 tab.

Methotrexate is used for treating certain types of cancer, severe psoriasis, or rheumatoid arthritis in certain patients.

Pharmachologic effect
An antitumor agent from the group of antimetabolites – folic acid antagonists. Acts in the S-phase of mitosis. The mechanism of action is associated with the inhibition of the synthesis of purine nucleotides and thymidylate as a result of irreversible binding to dihydrofolate reductase, which prevents the restoration of dihydrofolate to active tetrahydrofolate. More active against rapidly growing cells. It has some immunosuppressive effect.

Pharmacokinetics
To a small extent penetrates the BBB (depending on the dose used). With intrathecal administration, a significant amount enters the systemic circulation. Binding to plasma proteins (mainly with albumin) of plasma is about 50%. Biotransformed in the liver. It is excreted by the kidneys (unchanged) and with bile (less than 10%). T1 / 2 depends on the dose used and has significant individual differences. With repeated administration, it accumulates in the tissues in the form of metabolites.

Indications
Acute lymphocytic leukemia, trophoblastic disease, skin cancer, cervical and vulvar cancer, esophageal cancer, squamous cell carcinoma of the head and neck, cancer of the renal pelvis and ureter, osteogenic and soft-cell sarcoma, Ewing’s sarcoma, lung cancer, breast cancer, germ cell tumors of the testis and testicles , liver cancer, kidney cancer, retinoblastoma, medulloblastoma, penile cancer, lymphogranulomatosis.

Severe forms of psoriasis (in case of failure of standard therapy).

Severe form of rheumatoid arthritis (in case of failure of standard therapy).

Dosage regimen
It is taken orally, administered iv, intramuscularly, intramuscularly. Installed individually, depending on the indications and stage of the disease, the state of the hematopoietic system, anti-tumor therapy regimen.
Side effect
From the digestive system: possible ulcerative stomatitis, anorexia, gingivitis, pharyngitis, nausea; rarely – diarrhea, melena, enteritis, pancreatitis; in some cases (with prolonged daily use) – liver necrosis, cirrhosis, fatty atrophy, periportal liver fibrosis.

From the hemopoietic system: leukopenia, anemia, thrombocytopenia.

From the side of the central nervous system: feeling tired, dizziness; rarely – headache, aphasia, drowsiness, cramps.

From the reproductive system: disorders of oogenesis and spermatogenesis, oligospermia, menstrual irregularities, decreased libido, impotence.

From the urinary system: hematuria, cystitis, severe renal dysfunction.

Allergic reactions: chills, decreased resistance to infection; rarely – urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome.

Dermatological reactions: skin rash, photosensitivity, pigmentation disorders, telangiectasia, acne, furunculosis.

Contraindications
Severe impaired liver and / or kidney function, leukopenia, thrombocytopenia, pregnancy. Methotrexate should not be used in immunodeficiency conditions.

Pregnancy and lactation
Methotrexate is contraindicated in pregnancy. If necessary, use during lactation should stop breastfeeding.

Women of childbearing age should use reliable methods of contraception while using methotrexate.

In experimental studies, the embryotoxic and teratogenic effects of methotrexate have been established.

Use for impaired liver function
Contraindicated in severely impaired liver function.
Use for impaired renal function
Contraindicated in severe renal impairment.
special instructions
Methotrexate should not be used for ascites, pleural effusion, gastric ulcer and duodenal ulcer, ulcerative colitis, gout or nephropathy (including a history).

It is not recommended for use in patients with chickenpox (including recently transferred or after contact with patients), herpes zoster, and other acute infectious diseases.

Before starting therapy and against the background of the treatment, the picture of peripheral blood, liver and kidney function, chest x-ray should be monitored.

In the treatment of rheumatoid arthritis or psoriasis, a comprehensive blood count should be done at least 1 time per month, and laboratory tests of liver or kidney function at least 1 time in 1-2 months.

When used for psoriasis, the local treatment of the disease should not be interrupted. In case of an overdose, the use of calcium folinate is recommended (but not later than 4 hours later).

When conducting combination antitumor therapy, special care should be taken while using methotrexate in high doses with drugs that have a nephrotoxic effect (for example, with cisplatin).

It is not recommended to vaccinate patients and their families.

Methotrexate (even at low doses) with acetylsalicylic acid should be combined with caution.

In experimental studies, the carcinogenic and mutagenic effects of methotrexate have been established.

Drug interaction
With simultaneous use with vitamin preparations containing folic acid or its derivatives, a decrease in the effectiveness of methotrexate is possible.

The simultaneous use of NSAIDs in high doses can lead to an increase in the concentration of methotrexate in plasma and to an increase in its T1 / 2, as well as to an increase in the concentration of methotrexate not associated with plasma albumin, which in turn enhances the toxic effects of methotrexate (primarily on the gastrointestinal tract and system hematopoiesis).

With the simultaneous use of methotrexate with penicillins (even at low doses), its toxic effects may increase.

With simultaneous use with sulfonamides, especially with co-trimoxazole, there is a risk of increased myelodepressive effect.

When nitrous oxide is used in patients receiving methotrexate, severe unpredictable myelodepression and stomatitis may develop.

With the simultaneous use of valproic acid with methotrexate, a decrease in its concentration in blood plasma is possible.

Colestyramine binds methotrexate, reduces its enterohepatic recirculation, which leads to a decrease in its concentration in blood plasma.

With simultaneous use with mercaptopurine, it is possible to increase its bioavailability due to metabolic disorders during the “first passage” through the liver.

Neomycin and paromomycin reduce the absorption of methotrexate from the gastrointestinal tract.

In patients receiving omeprazole, an increase in the concentration of methotrexate in blood plasma is possible.

With simultaneous use with probenecid, a 3-4-fold increase in the concentration of methotrexate in blood plasma is possible due to a decrease in its renal excretion.

With the simultaneous use of methotrexate with retinoids, an increased risk of hepatotoxic action is possible.

Salicylates potentiate the effect of methotrexate due to a decrease in its renal excretion.

After a course of treatment with tetracycline, methotrexate, used even in low doses, can have a toxic effect.

With the sequential administration of methotrexate and fluorouracil, a synergy of action is possible; fluorouracil introduced before methotrexate may reduce its toxicity.

Cisplatin has a nephrotoxic effect and therefore can reduce the renal excretion of methotrexate, which leads to an increase in its toxicity.

Possible increased toxicity with cyclosporine in patients receiving methotrexate.

A description of the active substances of the drug is provided. The scientific information provided is generalized and cannot be used to decide on the possibility of using a particular drug.

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