Metotab tablets 10 mg No. 30




Metotab tablets are indicated for use:
in active rheumatoid arthritis in adult patients who are indicated for treatment with disease-modifying antirheumatic drugs (DMARDs); in severe and widespread forms of psoriasis vulgaris, especially plaque type, in adult patients with ineffectiveness of traditional therapy, for example, phototherapy, PUVA therapy and the use of retinoids; as maintenance therapy for acute lymphoblastic leukemia.Composition
One tablet contains 10 mg of methotrexate (as methotrexate sodium).
Excipients: lactose, pregelatinized starch, magnesium stearate.
Contraindication
hypersensitivity to methotrexate or to other components of the drug; significant liver dysfunction (bilirubin level > 85.5 μmol/l); alcohol abuse; renal dysfunction (creatinine clearance <20 ml/minute); existing disorders of the hematopoietic system (in particular bone marrow hypoplasia, leukopenia, thrombocytopenia or severe anemia); severe, acute or chronic infections (e.g. tuberculosis or HIV), immunodeficiency states; oral and gastrointestinal ulcers; pregnancy and breastfeeding; vaccination with live vaccines during methotrexate treatment.Method of application
Treatment with the drug "Metotab" should be carried out under the supervision of an oncologist, dermatologist or rheumatologist, as well as a therapist. Take the drug once a week. The doctor may indicate on the prescription the day of taking the drug. Swallow the tablets without chewing, 1 hour before or 1.5-2 hours after a meal.
Dosage
Psoriasis: The recommended initial dose is 7.5 mg per week as a single dose or, if the patient suffers from nausea, in divided doses (2.5 mg three times a week at 12-hour intervals); the dose may be increased gradually until the optimal response is achieved, but should not generally exceed 20 mg of methotrexate per week; a response to treatment can usually be expected after about 2-6 weeks, when the desired clinical effect is achieved, the dose should be gradually reduced to the lowest possible effective maintenance dose.
Rheumatoid arthritis: the recommended initial dose is 7.5 mg per week as a single dose or, if the patient suffers from nausea, in divided doses (2.5 mg three times a week at 12-hour intervals); depending on the individual activity of the disease and the patient's tolerance, the initial dose may be increased in increments of 2.5 mg per week; the weekly dose should not exceed 20 mg of methotrexate; a response to treatment can usually be expected after approximately 4-8 weeks, when the desired clinical effect is achieved, the dose should be gradually reduced to the lowest possible effective maintenance dose; in the absence of a therapeutic effect after 8 weeks of treatment with the maximum dose, methotrexate should be discontinued; the optimal duration of treatment with methotrexate has not yet been established, but preliminary data indicate that the initial effect is maintained for at least 2 years when using maintenance doses (after discontinuation of treatment, symptoms of the disease may reappear after 3-6 weeks).
Malignant oncological diseases: methotrexate can be used orally in doses up to 30 mg/m2 (higher doses must be administered parenterally); in maintenance therapy of acute lymphoblastic leukemia, methotrexate should be used in children orally in doses up to 20 mg/m2 per week in combination with intravenous and intrathecal administration to prevent central nervous system damage.
Application features
Children
The drug is 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 efficacy and safety of the drug for this group of patients.
Drivers
During treatment with methotrexate, such side effects from the central nervous system as fatigue and confusion may occur. "Metotab" has a weak or moderate adverse effect on the ability to drive or use machines.
Overdose
Cases of overdose (sometimes fatal) have occurred when patients mistakenly took the weekly dose daily. Symptoms in these cases include hematological and gastrointestinal reactions.
Side effects
The most serious side effects of methotrexate treatment are suppression of the hematopoietic system and adverse reactions from the digestive tract.
Storage conditions
Keep out of reach of children.
Shelf life - 5 years.
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