Methortritis 10 mg/ml 1.5 ml No. 1 syringe + needle
Content
Pharmacological properties Indications for use Contraindications With caution Pregnancy and lactation Method of administration and doses Method of administration and duration Note Side effects Overdose Interaction with other drugs Pharmaceutical incompatibility Special instructions Storage conditions
Pharmacological properties
An antitumor drug from the group of antimetabolites—folic acid analogues. Along with antitumor, it has an immunosuppressive effect.
Inhibits dihydrofolate reductase, which is involved in the reduction of dihydrofolic acid to tetrahydrofolic acid, a transporter of carbon fragments necessary for the synthesis of purine nucleotides and their derivatives.
Inhibits DNA synthesis, repair and cell mitosis (in S-phase). Tissues with high cell proliferation are especially sensitive to the action of methotrexate: tumor tissue, bone marrow, epithelial cells of the mucous membranes, embryonic cells.
The mechanism of action in rheumatoid arthritis is associated with the immunomodulatory and anti-inflammatory effect of the drug and is caused by the induction of apoptosis of rapidly proliferating cells (activated T-lymphocytes, fibroblasts, synoviocytes), inhibition of the synthesis of anti-inflammatory cytokines IL-1 (Interleukin 1), TNF-a (Tumor Necrosis Factor alpha) ), increased synthesis of anti-inflammatory cytokines IL-4 (Interleukin 4), IL-10 (Interleukin 10) and suppression of metalloproteinase activity.
In patients with rheumatoid arthritis, the use of methotrexate reduces symptoms of inflammation (pain, swelling, stiffness), but there is limited research on long-term use of methotrexate (regarding the ability to maintain remission in rheumatoid arthritis).
In psoriasis, the growth rate of keratinocytes in psoriatic plaques increases compared to the normal proliferation of skin cells. This difference in cell proliferation is the basis for the use of methotrexate to treat psoriasis.
Indications for use
- active form of rheumatoid arthritis in adults;
- systemic form of juvenile idiopathic arthritis in case of insufficient therapeutic response to non-steroidal anti-inflammatory drugs (NSAIDs);
- severe form of 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.
Contraindications
- hypersensitivity to methotrexate and/or to any other component of the drug;
- severe renal failure (creatinine clearance<20 ml/min);
- severe liver failure;
- alcohol abuse;
- a history of hematopoietic system disorders (in particular, bone marrow hypoplasia, leukopenia, thrombocytopenia or clinically significant anemia);
- immunodeficiency;
- severe acute and chronic infectious diseases such as tuberculosis and HIV infection;
- concomitant vaccination with live vaccines;
- stomatitis, oral ulcers, gastrointestinal ulcers in the active phase;
- simultaneous use of methotrexate at a dose of ≥15 mg/week. with acetylsalicylic acid;
- pregnancy;
- breastfeeding period.
Carefully
The drug should be used with caution if the patient has impaired liver and kidney function, diabetes mellitus, obesity and previous exposure to hepatotoxic drugs, dehydration, inhibition of bone marrow hematopoiesis, pleural or peritoneal effusion, parasitic and infectious diseases of viral, fungal or bacterial etiology (currently or recently suffered, including recent contact with a sick person), including such as herpes simplex, herpes zoster (viremic form), chicken pox, measles, amebiasis, strongyloidiasis (established or suspected) due to the risk of developing a severe generalized disease; gout (including a history) or urate nephrolithiasis (including a history), infection and inflammation of the oral mucosa, vomiting, diarrhea, gastric and duodenal ulcers, ulcerative colitis, obstructive gastrointestinal diseases, previous chemotherapy or radiation therapy, asthenia, aciduria (urine pH less than 7), as well as in children and elderly patients.
Pregnancy and lactation
Pregnancy
Methotrexate is contraindicated during pregnancy.
Taking methotrexate during pregnancy can cause serious fetal malformations (a 14-fold increase in the incidence of malformations of the skull, cardiovascular system and limbs).
If pregnancy occurs during treatment with methotrexate, it is necessary to consult with specialists regarding the risk of adverse effects of methotrexate on the fetus.
Fertility
Patients of reproductive age (women and men) should use effective contraception during and for at least 6 months after treatment with Methortrit.
Lactation
Methotrexate passes into breast milk in concentrations that are harmful to the baby. Therefore, during treatment with methotrexate, breastfeeding should be stopped.
Directions for use and doses
The drug Methortrit is prescribed subcutaneously, intramuscularly or intravenously. The injection needle included in the package is intended only for subcutaneous administration of Methortrit. To administer the drug intramuscularly or intravenously, it is necessary to use needles suitable for these routes of administration.
Doses
Methortritis can only be prescribed by doctors who are familiar with the various properties of the drug and its mode of action. Methorthritol is given by injection once a week.
It is necessary to clearly explain to the patient that treatment with Methortrit is carried out only once a week.
Doses for adult patients with rheumatoid polyarthritis:
It is recommended that a test dose be administered parenterally one week before the start of therapy to detect idiosyncratic adverse reactions.
The initial recommended dose is 7.5 mg methotrexate once a week, administered either subcutaneously, intramuscularly, or intravenously. Depending on the individual manifestation of the disease and the patient’s tolerance to therapy, the initial dose can be gradually increased by 2.5 mg per week. The dose should not exceed 25 mg per week. However, doses exceeding 20 mg per week may be associated with significant increases in toxicity, particularly bone marrow suppression. Response to treatment usually occurs within 4–8 weeks. After achieving the desired therapeutic result, the dose is gradually reduced to the lowest effective maintenance dose.
Doses for children and adolescents with polyarthritis forms of juvenile idiopathic arthritis (JIA):
The recommended dose is 10 - 15 mg/m2 body surface area (BSA)/week. If treatment is insufficiently effective, the weekly dose can be increased to 20 mg/m2 body surface area/week.
However, if the dose is increased, increasing the frequency of treatment monitoring is recommended.
Due to limited data regarding intravenous use in children and adolescents, parenteral use is limited to subcutaneous and intramuscular administration.
Patients with JIA should always refer to specialized units with experience in treating children/adolescents.
Use in children <3 years of age is not recommended due to insufficient data regarding the safety and effectiveness of use in this group of patients.
Dose for patients with severe psoriasis or psoriatic arthritis:
It is recommended to conduct a test dose of 5 - 10 mg, parenterally, one week before the start of therapy, to detect idiosyncratic adverse reactions.
The initial recommended dose is 7.5 mg methotrexate once a week, administered either subcutaneously, intramuscularly, or intravenously. The dose should be increased gradually as needed, but should not exceed the maximum weekly dose of 30 mg methotrexate. Response to treatment usually occurs within 2–6 weeks. After achieving the desired therapeutic result, the dose is gradually reduced to the lowest effective maintenance dose.
Patients with renal failure:
Methortrite should be used with caution in patients with renal impairment.
Patients with liver failure:
If absolutely necessary, methotrexate should be used with caution in patients with active liver disease or a history of liver disease, especially in connection with alcohol abuse. Methotrexate is contraindicated if the bilirubin concentration exceeds 5 mg/dL (85.5 µmol/L).
Elderly patients
Dosage reduction should be considered in elderly patients due to age-related declines in liver and kidney function and decreased folate reserves.
Use in patients who have an additional volume of distribution (pleural effusion, ascites)
Because the half-life of Methortrexate may be prolonged by up to 4 times the normal value, dose reduction or, in some cases, discontinuation of methotrexate may be necessary in patients who have additional volume of distribution.
Directions for use and duration
The prefilled Methortrit syringe is for one use only.
Methortrite, solution for injection, can be administered subcutaneously, intramuscularly, or intravenously.
In adults, intravenous use should be given as a bolus.
The total duration of treatment is determined by the doctor.
The injection solution must be visually inspected before use.
Only a clear solution, practically free of particles, should be used.
Any contact of methotrexate with the skin or mucous membranes should be avoided! In case of contamination, the affected area should be washed with plenty of water.
Treatment of rheumatoid polyarthritis, juvenile idiopathic arthritis, severe psoriasis and psoriatic arthritis with Methortrit is carried out over a long period of time.
Note
When switching from oral to parenteral administration, dose reductions may be necessary due to varying bioavailability after oral administration.
In accordance with current treatment guidelines, the administration of folic acid or folinic acid supplements should be considered.
Side effects
- From the cardiovascular system:
vasculitis (as acute toxic symptoms), pericarditis, pericardial effusion, cardiac tamponade, decreased blood pressure, thromboembolic complications (including cerebral vascular thrombosis and arterial thrombosis, thrombophlebitis, deep vein thrombosis, retinal vein thrombosis, pulmonary embolism).
- From the hematopoietic system:
leukopenia, thrombocytopenia, anemia, pancytopenia, agranulocytosis, hematopoietic disorders, megaloblastic anemia, severe bone marrow suppression, aplastic anemia, enlarged lymph nodes, lymphoproliferative diseases (partially reversible), eosinophilia and neutropenia. The first signs of these complications, which are life-threatening, are fever, sore throat, mouth ulcers, flu-like symptoms, nosebleeds and skin hemorrhages. Methotrexate should be stopped immediately if the blood cell count decreases significantly.
- General reactions:
allergic reactions, anaphylactic shock, diabetes mellitus, sepsis, opportunistic infections (in some cases can be fatal), infections caused by Cytomegalovirus. In addition, cases of nocardiosis, histoplasmosis and cryptococcal fungal infections, disseminated forms of herpes simplex, immunosuppression, hypogammaglobulinemia, allergic vasculitis, insomnia, and tinnitus have been reported.
- From the nervous system:
headache, feeling tired, drowsiness, dizziness, feeling confused, convulsions, depression, mood disorders, pain, muscle weakness or numbness in the limbs, impaired taste (metallic taste), acute aseptic meningitis with meningism (paralysis, vomiting).
- From the side of the organ of vision:
severe visual impairment, conjunctivitis, retinopathy, transient blindness.
- Neoplasms:
isolated cases of lymphomas that decrease when methotrexate treatment is stopped. A recent study did not find that methotrexate therapy increased the incidence of lymphoma.
- From the respiratory system:
pulmonary complications due to interstitial alveolitis/pneumonitis and death associated with this (regardless of the dose and duration of treatment with methotrexate). Typical symptoms: malaise, dry irritating cough, shortness of breath progressing to shortness of breath at rest, chest pain, fever. If such complications are suspected, stop methotrexate immediately and exclude infections (including pneumonia), pulmonary fibrosis, pharyngitis, apnea, asthma reactions with cough, shortness of breath and abnormal results of pulmonary function tests, pneumonia with Pneumocystis carinii and other lung infections, difficult breathing, obstructive pulmonary disease. Pleural effusion.
- From the gastrointestinal tract:
loss of appetite, nausea, vomiting, abdominal pain, inflammation of the mucous membrane of the mouth and throat and the formation of ulcers (especially in the first 24–48 hours after using methotrexate), stomatitis, dyspepsia, diarrhea (especially in the first 24–48 hours after using methotrexate) , ulcers and bleeding of the gastrointestinal tract, enteritis, melena, gingivitis, malabsorption, hematemesis, toxic megacolon.
- From the side of liver function:
increased activity of liver enzymes (ALT, AST, alkaline phosphatase and bilirubin concentrations), the occurrence of steatosis, fibrosis and cirrhosis of the liver (often appear even with regular monitoring of normal liver enzyme values). Decreased serum albumin concentration, acute hepatitis and hepatotoxicity, reactivation of chronic hepatitis, acute liver dystrophy, liver failure. The most common hepatitis is caused by the herpes simplex virus and is accompanied by liver failure.
- For the skin and skin appendages:
exanthema, erythema, itching, urticaria, photosensitivity, increased skin pigmentation, hair loss, abnormal wound healing, enlarged rheumatic nodes, herpes zoster, painful lesions of psoriatic plaques (psoriatic plaques may be aggravated by UV radiation during concomitant treatment with methotrexate), severe toxic reactions, vasculitis, herpetiform skin rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), changes in nail pigmentation, onycholysis, petechiae, ecchymosis, erythema multiforme, erythematous skin rash, acute paronychia, furunculosis, telangiectasia, hidradenitis.
- From the musculoskeletal system:
arthralgia, myalgia, osteoporosis, stress fractures, osteonecrosis, unknown: soft tissue necrosis.
- From the genitourinary and urinary systems:
inflammation and ulceration of the bladder or vagina (possibly with hematuria), dysuria, renal failure, oliguria, anuria, azotemia, oligospermia, menstrual irregularities, proteinuria, decreased libido, impotence, vaginal discharge, infertility, gynecomastia, impaired oogenesis and spermatogenesis, teratogenic action.
- Reactions at the injection site:
after intramuscular use of methotrexate, local adverse reactions (burning) or tissue damage (formation of sterile abscesses, destruction of fat deposits), and fever may appear at the injection site. Subcutaneous administration of methotrexate shows good local tolerability. To date, only mild local reactions have been observed, which have decreased during treatment.
The frequency and severity of adverse reactions depend on the dose and frequency of use. Since severe adverse reactions can occur at low doses, it is extremely important that patients undergo medical examination regularly and at short intervals.
Overdose
Symptoms: the most commonly observed symptoms are those associated with inhibition of the hematopoietic system.
Treatment: the specific antidote for methotrexate is calcium folinate. It neutralizes adverse toxic effects.
In case of accidental overdose, no later than an hour after the administration of methotrexate, administer calcium folinate (IV or IM) in a dose equal to or higher than the dose of methotrexate. The administration of calcium folinate is continued until the concentration of methotrexate in the blood serum decreases below the level of 10-7 mmol/l.
In case of significant overdose, it may be necessary to rehydrate the body and alkalinize the urine (pH more than 7) to prevent precipitation of methotrexate and/or its metabolites in the renal tubules. Hemodialysis and peritoneal dialysis do not improve the elimination of methotrexate. Intensive intermittent hemodialysis using high-flux dialyzers allows effective clearance of methotrexate to be ensured.
Interaction with other drugs
The likelihood of hepatotoxicity from methotrexate increases with regular alcohol consumption and concomitant use of other hepatotoxic drugs.
With combination therapy with methotrexate and leflunomide, the incidence of pancytopenia and hepatotoxic effects increases.
Oral antibiotics (tetracyclines, chloramphenicol and non-absorbable broad-spectrum antibiotics) may reduce the absorption of methotrexate from the gastrointestinal tract and interfere with the enterohepatic circulation due to inhibition of intestinal microflora or suppression of bacterial metabolism.
Penicillins, ciprofloxacin, cephalothin, glycopeptides can reduce the renal clearance of methotrexate, as a result of which its concentration in the blood serum may increase and the toxic effect on the hematopoietic system and gastrointestinal tract may increase.
Probenecid, weak organic acids (for example, loop diuretics) and pyrazoles (phenylbutazone) may slow down the elimination of methotrexate, which may result in increased serum concentrations and increased hematological toxicity.
The risk of toxic effects of methotrexate increases in case of combined use with NSAIDs or salicylates (reduced excretion of methotrexate by the renal tubules is possible; caution should be exercised when combining non-steroidal anti-inflammatory drugs with methotrexate).
When concomitant therapy with drugs that may have an adverse effect on the bone marrow (for example, sulfonamides, trimethoprim/sulfamethoxazole, chloramphenicol, pyrimethamine), the possibility of developing more severe hematological disorders should be taken into account.
With concomitant therapy with drugs that cause folate deficiency (for example, trimethoprim/sulfamethoxazole), the toxic effect of methotrexate may be enhanced.
The simultaneous use of indirect anticoagulants and lipid-lowering drugs (cholestyramine) increases the toxicity of methotrexate.
With the combined use of antirheumatic drugs (for example, gold salts, penicillamines, hydroxychloroquines, azathioprines, cyclosporines) and methotrexate, the toxic effect of the latter is not enhanced. In the case of simultaneous use of sulfasalazine and methotrexate, the effect of the latter may be potentiated due to inhibition of folic acid synthesis.
When methotrexate is co-administered with proton pump inhibitors (e.g. omeprazole or pantoprazole), the renal elimination of methotrexate may be delayed and pantoprazole may inhibit the renal elimination of the 7-hydroxymethotrexate metabolite, which in one case was accompanied by the development of myalgia and tremor.
During treatment with methotrexate, excessive consumption of drinks containing caffeine and theophylline (coffee, sweet drinks containing caffeine, black tea) should be avoided. Methotrexate reduces the clearance of theophylline.
It is necessary to take into account the pharmacokinetic interaction between methotrexate and flucloxacillin and anticonvulsants (the concentration of methotrexate in the blood decreases), 5-fluorouracil (the half-life of 5-fluorouracil increases).
When used together with other cytostatics, the clearance of methotrexate may be reduced.
Concomitant use of vitamin supplements or oral iron supplements containing folic acid may weaken the response to therapy and reduce the toxic effect of methotrexate on the bone marrow.
When mixing solutions of methotrexate with chlorpromazine hydrochloride, droperidol, idarubicin, metoclopramide hydrochloride, heparin, prednisolone sodium phosphate and promethazine hydrochloride, precipitation or turbidity of the solution may occur.
The use of drugs with additive hematotoxic effects (eg, metamizole) increases the likelihood of serious hematotoxic effects of methotrexate.
Due to competitive binding to serum albumin, with simultaneous use of methotrexate with salicylates, phenylbutazone, phenytoin, barbiturates, tranquilizers, oral contraceptives, tetracyclines, amidopyrine derivatives, sulfonamides and p-aminobenzoic acid, the toxicity of methotrexate may be increased.
Several patients with psoriasis or mycosis fungoides treated with methotrexate in combination with PUVA therapy (methoxsalen and ultraviolet radiation) have been diagnosed with skin cancer.
Caution should be exercised when administering packed red blood cells and methotrexate simultaneously.
Combination with radiotherapy may increase the risk of soft tissue necrosis.
Methotrexate may reduce the immunological response to vaccination. When administered simultaneously with a live vaccine, severe antigenic reactions may develop.
L-asparaginase is an antagonist of methotrexate.
Anesthesia using dinitrogen oxide can lead to the development of unpredictable severe myelosuppression and stomatitis.
Amiodarone may promote skin ulceration.
Pharmaceutical incompatibility
Methortrit should not be mixed with other medications or solvents.
special instructions
Impact on the ability to drive vehicles and perform work requiring increased speed of psychomotor reactions.
During treatment with Methortritis, you should refrain from driving vehicles or operating other machinery, as side effects from the nervous system (fatigue and dizziness) may occur.
Storage conditions
At a temperature not exceeding 25 °C, in the original packaging.
Keep out of the reach of children!
Do not freeze!
Shelf life: 2 years.
The drug should be used immediately after opening.
You can order Methortrit on the Omnifarm pharmacy website
Metortrit
If a significant amount of fluid in the pleural cavities or ascites is detected in a patient, the fluid should be evacuated by drainage before starting methotrexate therapy, or the use of methotrexate should be discontinued.
The appearance of symptoms of toxic damage to the digestive system, the earliest of which are stomatitis and diarrhea, requires temporary cessation of methotrexate therapy due to the high risk of developing hemorrhagic enteritis and intestinal perforation with a fatal outcome if therapy is continued. During treatment with methotrexate
Patients should be closely monitored for signs of possible toxicity and adverse effects. Given the risk of severe or even fatal toxic reactions, patients should be thoroughly informed about possible complications and recommended precautions.
Before starting treatment with methotrexate or when resuming therapy after a break, it is necessary to conduct a clinical blood test with counting the leukocyte formula and platelet count, assess the activity of liver enzymes, the concentration of bilirubin, serum albumin, as well as a chest x-ray and renal function tests. If there are clinical indications, studies are prescribed to exclude tuberculosis and hepatitis.
During treatment with methotrexate (monthly in the first 6 months and at least every 3 months thereafter, and as doses increase, it is advisable to increase the frequency of examinations), the following studies are carried out:
1. Examination of the mouth and throat to identify changes in the mucous membranes.
2. Blood test to determine the leukocyte formula and platelet count.
Even when used in normal therapeutic doses, methotrexate can suddenly cause depression of the hematopoietic system. If there is a significant decrease in the number of leukocytes or platelets, treatment with methotrexate is stopped immediately and symptomatic supportive therapy is prescribed. Patients should be instructed to immediately report any signs and symptoms indicating an infection to their physician. During concomitant therapy with hematotoxic drugs (for example, leflunomide), it is necessary to carefully monitor the number of leukocytes and platelets in the blood.
During long-term treatment with methotrexate, if necessary, a bone marrow biopsy is advisable.
3. Functional “liver” tests.
Particular attention should be paid to identifying signs of liver damage. Treatment with methotrexate should not be started or should be suspended if any abnormal results of liver function tests or liver biopsy are detected. Typically, the indicators return to normal within two weeks, after which treatment can be resumed according to the doctor’s decision.
In 13–20% of patients, a short-term increase of 2–3 times in the activity of “liver” enzymes was observed. A persistent increase in liver enzyme activity and/or a decrease in serum albumin concentrations may be indicators of severe hepatotoxicity. Enzyme diagnostics do not in all cases provide adequate prediction of the development of hepatotoxicity detected morphologically; even in the case of normal values of the activity of “liver” enzymes, liver fibrosis, or, much less commonly, liver cirrhosis, can be detected histopathologically.
When using methotrexate for rheumatological indications, there is no reason to perform a liver biopsy to monitor the hepatotoxic effect of the drug.
When treating patients with psoriasis, it is necessary to evaluate the advisability of performing a liver biopsy before or during treatment with methotrexate, based on current scientific recommendations. If biochemical liver function tests or type III collagen propeptide concentrations do not reveal signs of hepatotoxicity, additional studies may be necessary. This assessment should differentiate between patients without risk factors and patients at risk (for example, patients with a history of alcohol abuse, persistently elevated liver enzymes, a history of liver disease, a family history of hereditary liver disease, patients with diabetes mellitus, obese patients, and previously taken hepatotoxic drugs or exposed to hepatotoxic chemicals and received long-term treatment with methotrexate in total doses of 1.5 g or more). In the case of a persistent increase in the activity of liver enzymes, it is necessary to reduce the dose or stop treatment with methotrexate.
Since methotrexate has a toxic effect on the liver, other hepatotoxic drugs should not be prescribed during treatment with the drug unless clearly necessary.
You should also avoid or greatly reduce your alcohol consumption. The activity of liver enzymes should be especially carefully monitored in patients receiving concomitant therapy with other hepatotoxic and hematotoxic drugs (in particular, leflunomide). Particular caution should be observed when treating patients with insulin-dependent diabetes mellitus, since cases of the development of liver cirrhosis have been described with a previous periodic increase in the activity of “liver” enzymes.
4. Renal function tests and urine examination.
If the serum creatinine concentration increases, the dose of methotrextate should be reduced. At creatinine concentration. exceeding 2 mg/dL, the use of methotrexate is contraindicated.
Since methotrexate is excreted primarily by the kidneys, patients with impaired renal function may experience increased concentrations of methotrexate in the blood, which may result in severe adverse reactions. It is necessary to carefully monitor the condition of patients who may have impaired renal function (for example, elderly patients). This is especially important in the case of concomitant therapy with drugs that reduce the excretion of methotrexate, have an adverse effect on the kidneys (in particular, NSAIDs) or on the hematopoietic system. If there are risk factors such as renal failure. simultaneous use of non-steroidal anti-inflammatory drugs is not recommended. Dehydration may also potentiate the toxic effects of methotrexate.
5. Study of respiratory function
systems. It is necessary to closely monitor symptoms of possible development of pulmonary function disorders and, if necessary, order a pulmonary function test.
Pulmonary diseases require rapid diagnosis and discontinuation of methotrexate. The appearance of corresponding symptoms (especially a dry, nonproductive cough) or the development of nonspecific pneumonitis during treatment with methotrexate may indicate a potential danger of lung damage. In such cases, methotrexate is discontinued and the patient is carefully examined. Although the clinical presentation may vary, the typical patient with methotrexate-induced pulmonary disease will have fever, cough with dyspnea, hypoxemia, and pulmonary infiltrates on x-ray. In the differential diagnosis, infectious diseases should be excluded. Lung damage can occur during treatment with methotrexate at any dose.
During treatment with methotrexate, opportunistic infections may develop, including pneumonia caused by Pneumocystis carinii, which can be fatal. If the patient exhibits symptoms of pulmonary involvement, pneumonia caused by Pneumocystis carinii should be excluded.
Caution is recommended when treating patients with pulmonary insufficiency.
6. Because methotrexate affects the immune system, it may alter the response to vaccinations and affect the results of immunological tests. Particular caution is required when treating patients with inactive, chronic infections (such as herpes zoster, tuberculosis, hepatitis B or C) due to their possible activation. During treatment with methotrexate, vaccination with live vaccines should not be performed.
It is recommended that methotrexate treatment be interrupted one week before surgery and restarted one or two weeks after surgery.
When body temperature rises (more than 38°C), the elimination of methotrexate slows down significantly.
Methotrexate may increase the risk of developing neoplasms (mainly lymphomas). Malignant lymphomas can also develop in patients receiving low-dose methotrexate. In such cases, the drug is discontinued. If spontaneous regression of lymphoma is not observed, therapy with cytotoxic drugs is prescribed.
Before starting treatment with Methortritis, pregnancy must be excluded. Methotrexate has an embryotoxic effect, promotes abortion and the formation of fetal development abnormalities. Methotrexate therapy is accompanied by inhibition of spermatogenesis and oogenesis, which can lead to decreased fertility. After discontinuation of methotrexate therapy, these effects spontaneously regress. During methotrexate therapy and for 6 months after its completion, patients are advised to use contraception.
Patients of reproductive age, as well as their partners, should be informed about the possible effect of methotrexate on reproduction and fetal development.
Precipitation may occur during high dose therapy.
methotrexate or its metabolites in the renal tubules. In such cases, to prevent this complication, it is recommended to carry out infusion therapy and alkalization of urine until a pH of 6.5-7.0 is achieved through oral or intravenous administration of sodium bicarbonate (5 tablets of 625 mg every 3 hours) or acetazolamide (500 mg orally 4 times a day) .
Methotrexate should not be mixed with other medications in the same infusion bag or vial.
When handling methotrexate solution, you must follow the rules for handling cytotoxic substances. Pregnant healthcare workers should not work with the drug.
Measures should be taken to prevent the solution from entering
methotrexate on the skin and mucous membranes. If the drug does get on the skin or mucous membranes, the affected area is immediately washed with plenty of water.