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METHOTREXATE is a brand name for Methotrexate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Active rheumatoid arthritis in adult patients. - Severe forms of psoriasis vulgaris, particularly of the plaque type, which cannot be sufficiently treated with conventional therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis.
Verbatim from this product's MHRA label. Tap a section to expand.
Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risk of methotrexate therapy. The prescriber should ensure that patients or their carers will be able to comply with the once weekly regimen.
For doses not realisable/practicable with this strength another strength of this medicinal product is available.
Important warning about the dosage of methotrexate:
In the treatment of rheumatoid arthritis and psoriasis, methotrexate must only be taken once a week. Dosage errors in the use of methotrexate can result in serious adverse reactions, including death. Please read this section of the summary of product characteristics very carefully.
The prescriber should specify the day of intake on the prescription. 5 - 15 mg once weekly. The schedule may be adjusted gradually to achieve an optimal response but should not exceed a total weekly dose of 20 mg. Thereafter the dose should be reduced to the lowest possible effective dose which in most cases is achieved within 6 weeks.
0 mg to exclude unexpected toxic effects. If, one week later, appropriate laboratory tests are normal, treatment may be initiated. 5–15 mg taken once weekly. As necessary, the total weekly dose can be increased up to 25 mg. Thereafter the dose should be reduced to the lowest effective dose according to therapeutic response which in most cases is achieved within 4 to 8 weeks.
The patient should be fully informed of the risks involved and the clinician should pay particular attention to the appearance of liver toxicity by carrying out liver function tests before starting methotrexate treatment, and repeating these at 2 to 4 month intervals during therapy.
The aim of therapy should be to reduce the dose to the lowest possible level with the longest possible rest period. The use of methotrexate may permit the return to conventional topical therapy which should be encouraged. Use in elderly Methotrexate should be used with extreme caution in elderly patients, a dose reduction should be considered due to reduced liver and kidney function as well as lower folate reserves which occurs with increased age.
4). The health care provider may need to adjust the dose to prevent accumulation of drug. The table below provided recommended starting doses in renally impaired patients; dosing may need further adjustment due to wide intersubject pK variability.
In general, the incidence and severity of side effects are considered to be-related to the dose, the dosing frequency, the method of administration and the duration of exposure. 4). The most common adverse reactions of methotrexate are bone marrow suppression and mucosal damage which manifest as ulcerative stomatitis, leukopaenia, nausea and other gastrointestinal disorders.
These adverse reactions are generally reversible and corrected in about two weeks after the single dose of methotrexate has been reduced or dose interval increased and/or calcium folinate is used. g. malaise, abnormal fatigue, chills and fever, dizziness and reduced immunity to infections.
g. in the treatment of cancer diseases. Adverse reactions reported on methotrexate are given below according to organ systems.
The frequencies of the adverse reactions are classified as follows:
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000), not known (cannot be estimated from the available data). 4). 4. 3 Gastrointestinal severe adverse reactions require often dose reduction.
Description of selected adverse reactions Lymphoma/Lymphoproliferative disorders: there have been reports of individual cases of lymphoma and other lymphoproliferative disorders which subsided in a number of cases once treatment with methotrexate had been discontinued.
Ulcerative stomatitis and diarrhoea require discontinuation of methotrexate therapy because of the risk of ulcerative enteritis and fatal intestinal perforation. The following adverse reactions have also been reported, but their frequency is not known: pancytopaenia, sepsis resulting in death, miscarriage, fetal damages, increased risk of toxic reactions (soft tissue necrosis, osteonecrosis) during radiotherapy, eosinophilia, alveolitis.
It should be emphasized to the patient that the recommended dose must be taken only once a week. The prescriber should specify the day of intake on the prescription. 9). Methotrexate should be used with extreme caution in patients with haematological depression, renal impairment, diarrhoea, ulcerative disorders of the GI tract and psychiatric disorders.
Hepatic toxicity has been observed, usually associated with chronic hepatic disease. The administration of low doses of methotrexate for prolonged periods may give rise, in particular, to hepatic toxicity. Liver function should be closely monitored.
If hepatic function abnormalities develop, methotrexate dosing should be suspended for at least two weeks. It is only appropriate to restart methotrexate provided the abnormalities return to normal and the re-exposure is deemed appropriate.
Particular care and possible cessation of treatment are indicated if stomatitis or GI toxicity occurs as haemorrhagic enteritis and intestinal perforation may result. Reversible eosinophilic pulmonary reactions and treatment-resistant, interstitial fibrosis may occur, particularly after long-term treatment.
Methotrexate therapy in patients with impaired renal function should be undertaken with extreme caution because impairment of renal function will decrease methotrexate elimination. Renal function should be monitored by renal function tests and urinalyses.
If serum creatinine levels are increased, the dose should be reduced. 3). 0. 8) for at least the first 24 hours after the administration of methotrexate is started. Renal lesions may develop if the urinary flow is impeded and urinary pH is low, especially if large doses have been administered.
Methotrexate may cause renal damage that may lead to acute renal failure. Close attention to renal function including adequate hydration, urine alkalinization, and measurement of serum methotrexate and renal function are recommended.
6). 1 • During methotrexate therapy concurrent vaccination with live vaccines must not be carried out. g. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Methotrexate in United Kingdom.
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4). Use in a patient with a third distribution space (pleural effusions, ascites) As the half-life of Methotrexate can be prolonged to 4 times the normal length in patients who possess a third distribution space dose reduction or, in some cases, discontinuation of methotrexate administration may be required.
Special note If changing the oral application to parenteral administration a reduction of the dose may be required due to the variable bioavailability of methotrexate after oral administration. Method of Administration Oral.
The psoriatic lesions may get worse from simultaneous exposure to methotrexate and ultraviolet radiation. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
As methotrexate is eliminated mainly via the kidneys, increased concentrations are to be expected in the presence of renal impairment, which may result in severe adverse reactions. g. in elderly subjects), monitoring should take place at shorter intervals.
g. NSAIDs) or that can potentially lead to impairment of haematopoiesis, are administered concomitantly. If risk factors such as renal function disorders, including mild renal impairment, are present, combined administration with NSAIDs is not recommended.
Dehydration may also intensify the toxicity of methotrexate. Concomitant use of proton pump inhibitors (PPIs) and high dose methotrexate should be avoided, especially in patients with renal impairment. Haematopoietic suppression caused by methotrexate may occur abruptly and with apparently safe dosages.
Full blood counts should be closely monitored before, during and after treatment. 8, Undesirable Effects). Patients should be advised to report all symptoms or signs suggestive of infection. Malignant lymphomas may occur in patients receiving low dose methotrexate, in which case therapy must be discontinued.
Failure of the lymphoma to show signs of spontaneous regression requires the initiation of cytotoxic therapy. Progressive multifocal leukoencephalopathy (PML) Cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients receiving methotrexate, mostly in combination with other immunosuppressive medication.
PML can be fatal and should be considered in the differential diagnosis in immunosuppressed patients with new onset or worsening neurological symptoms. Liver function tests Treatment should not be initiated or should be discontinued if there are persistent or significant abnormalities in liver function tests, other non-invasive investigations of hepatic fibrosis, or liver biopsies.
Temporary increases in transaminases to two or three times the upper limit of normal have been reported in patients at a frequency of 13-20 %. Persistent elevation of liver enzymes and/or decrease in serum albumin may be indicative for severe hepatotoxicity.
In the event of a persistent increase in liver enzymes, consideration should be given to reducing the dose or discontinuing therapy. Histological changes, fibrosis and more rarely liver cirrhosis may not be preceded by abnormal liver function tests.
There are instances in cirrhosis where transaminases are normal. Therefore, non-invasive diagnostic methods for monitoring of liver condition should be considered, in addition to liver function tests. Liver biopsy should be considered on an individual basis taking into account the patient’s comorbidities, medical history and the risks related to biopsy.
Risk factors for hepatotoxicity include excessive prior alcohol consumption, persistent elevation of liver enzymes, history of liver disease, family history of hereditary liver disorders, diabetes mellitus, obesity and previous contact with hepatotoxic drugs or chemicals and prolonged methotrexate treatment.
Additional hepatotoxic medicinal products should not be given during treatment with methotrexate unless clearly necessary. Alcohol consumption should be […]