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MAXTREX is a brand name for Methotrexate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Methotrexate is a folic acid antagonist and is classified as an antimetabolite cytotoxic agent. Methotrexate is used in the treatment of adults with severe, active, classical or definite rheumatoid arthritis who are unresponsive or intolerant to conventional therapy. Methotrexate has also been used in the treatment of…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. The prescriber should ensure that patients or their carers will be able to comply with the once weekly regimen.
Dosage for Cancer Treatment Warning The dose must be adjusted carefully depending on the body surface area if methotrexate is used for the treatment of neoplastic diseases. Fatal cases of intoxication have been reported after administration of incorrectly calculated doses.
Health care professionals and patients should be fully informed about toxic effects. Oral administration A test dose of 5 - 10 mg parenterally is recommended, one week prior to therapy to detect idiosyncratic adverse events. Low doses not exceeding 30 mg/m2 on five successive days.
Thereafter an interval of at least two weeks is recommended to allow the bone marrow to recover. Doses in excess of 100 mg are usually given parenterally, when the injectable preparation should be used. Doses in excess of 70 mg/m2 should not be administered without leucovorin rescue (folinic acid rescue) or assay of serum methotrexate levels 24 - 48 hours after dosing.
If methotrexate is administered in combination chemotherapy regimens, the dosage should be reduced, taking into consideration any overlapping toxicity of the other drug components. Dosage for Psoriasis and Rheumatoid arthritis Important warning about the dosage of Maxtrex Tablets (methotrexate) In the treatment of psoriasis and Rheumatoid arthritis, Maxtrex Tablets (methotrexate) must only be used once a week.
Dosage errors in the use of Maxtrex Tablets (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.
0 mg to exclude unexpected toxic effects. If, one week later, appropriate laboratory tests are normal, treatment may be initiated. 5 – 15 mg once a week. For the treatment of severe psoriasis, the total weekly dosage can be raised to 20 - 25 mg administered orally as necessary.
Dosage should be adjusted according to the patient’s response and the haematological toxicity. 5-15 mg once a week. The total weekly dosage can be raised to 20-25 mg as necessary. Dosage should be adjusted according to the patient’s response and the haematological toxicity.
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. Most adverse reactions are reversible if detected early.
When adverse reactions do occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken. 4). Methotrexate therapy should only be resumed with particular caution, after careful consideration of the need for treatment and with increased vigilance for the possible recurrence of toxicity.
Most serious adverse reactions of methotrexate include bone marrow suppression, pulmonary toxicity, hepatotoxicity, renal toxicity, neurotoxicity, thromboembolic events, anaphylactic shock and Stevens-Johnson syndrome. g. g. increased Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), bilirubin, alkaline phosphatase).
Other frequently occurring adverse reactions are leukopenia, anaemia, thrombocytopenia, headache, tiredness, drowsiness, pneumonia, interstitial alveolitis/pneumonitis often associated with eosinophilia, oral ulcers, diarrhoea, exanthema, erythema and pruritus.
The most relevant adverse reaction is suppression of the haematopoietic system and gastrointestinal disorders. In the antineoplastic treatment, myelosuppression and mucositis are the predominant dose-limiting toxic effects of methotrexate.
The severity of these reactions depends on the dose, mode and duration of application of methotrexate. Mucositis generally appears about 3 to 7 days after methotrexate application, leucopenia and thrombocytopenia follow a few days later.
In patients with unimpaired elimination mechanisms, myelosuppression and mucositis are generally reversible within 14 to 28 days.
Methotrexate must be used only by physicians experienced in antimetabolite chemotherapy. Patients must be appropriately monitored during treatment so that signs of possible toxic effects or adverse reactions can be detected and evaluated with minimal delay.
, following prior radio- or chemotherapy), impaired general condition as well as advanced age and in very young children. Because of the possibility of severe or even fatal toxic reactions, patients should be extensively informed by the treating doctor of the risks involved (including early signs and symptoms of toxicity) and the recommended safety measures.
Patients should be informed that they must notify the doctor immediately if any symptoms of an overdose occur and that the symptoms of the overdose need to be monitored (including regular laboratory tests). Doses exceeding 20 mg week can be associated with a substantial increase in toxicity, especially bone marrow depression.
3). 3). Skin and mucosal contact with methotrexate injection solution is to be avoided. g. leflunomide) is not advisable. Acute or chronic interstitial pneumonitis, often associated with blood eosinophilia, may occur and deaths have been reported.
Symptoms typically include dyspnoea, cough (especially a dry non-productive cough) and fever for which patients should be monitored at each follow-up visit. Patients should be informed of the risk of pneumonitis and advised to contact their doctor immediately should they develop persistent cough or dyspnoea.
Methotrexate should be withdrawn from patients with pulmonary symptoms and a thorough investigation (including chest X-ray) undertaken to exclude infection and tumours. If methotrexate induced lung disease is suspected, treatment with corticosteroids should be initiated and treatment with methotrexate should not be restarted.
5 mg/week). For the treatment of psoriasis, methotrexate should be restricted to severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when diagnosis has been established by biopsy and/or after dermatological consultation.
3. g. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Paediatric population Treatment should follow currently valid protocols for children. Safety and effectiveness in children have not been established, other than in cancer chemotherapy.
Use in Elderly:
Methotrexate should be used with extreme caution in elderly patients. A reduction in dosage should be considered due to reduced liver and kidney function as well as lower folate reserves, which occur 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. Table 3 a. Dose adjustments for methotrexate doses <100 mg/m2 in patients with renal impairment Creatinine Clearance (ml/min) % of dose to Administer >60 100 30-59 50 <30 Methotrexate must not be administered.
Table 3 b. Dose adjustments for methotrexate doses >100 mg/m2 in patients with renal impairment Creatinine Clearance (ml/min) % of dose to Administer >80 100 = ~80 75 = ~60 63 <60 Methotrexate must not be administered. 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.
Adverse reactions for the various systems are as follows:
Skin and subcutaneous tissue disorders: Exanthema, Stevens-Johnson Syndrome, toxic epidermal necrolysis, erythematous rashes, pruritus, urticaria, photosensitivity reactions (frequency uncommon), pigmentary changes, erythema multiforme, onycholysis, increased pigmentation, petechia, allergic vasculitis, hidradenitis, alopecia, depigmentation, ecchymosis, telangiectasia, acne, furunculosis, painful damage to psoriatic lesions, skin ulceration, herpetiform eruptions of the skin, hyperpigmentation of the nails and acute paronychia.
Skin exfoliation and dermatitis exfoliative (frequency not known). The recall phenomenon has been reported in both radiation and solar damaged skin. Lesions of psoriasis may worsen with concomitant UV therapy. Radiation dermatitis and sunburn may be “recalled”.
Blood and the lymphatic system disorders:
Megaloblastic anaemia, hematopoietic disorders, eosinophilia, lymphoproliferative disorder (partly reversible), lymphadenopathy, bone marrow depression (especially at high-dose of methotrexate) is most frequently manifested by thrombocytopenia (which are usually reversible), neutropenia, leukopenia, pancytopenia, agranulocytosis, anaemia, aplastic anaemia, immunosuppression, lymphoproliferative disorders (frequency very rare) or any combination may occur.
Infection or hypogammaglobulinaemia, haemorrhage from various sites. Bone marrow depression may lead to decreased resistance to infection and sepsis.
Gastrointestinal disorder:
Mucositis, stomatitis, gingivitis, hematemesis, melena, pancreatitis, enteritis, gastrointestinal ulceration (including oral ulcers) and bleeding, malabsorption, toxic mega-colon, dyspepsia, abdominal pain, anorexia, nausea, vomiting, diarrhoea.
Gastrointestinal disorders frequently require dosage adjustment. Ulcerative stomatitis and diarrhoea require interruption of therapy; otherwise hemorrhagic enteritis and death from intestinal perforation may occur.
Hepatobiliary disorders:
Hepatic toxicity resulting in increase of transaminases (ASAT, ALAT), alkaline phosphatase and bilirubin, decrease in serum albumin, acute hepatitis, periportal fibrosis or hepatic cirrhosis, hepatic failure, fatty degeneration of liver, reactivation of chronic hepatitis or death.
Renal and urinary disorders:
Renal failure, uraemia, ulceration of the urinary bladder, disturbed micturition, oliguria, haematuria, dysuria, anuria, proteinuria, electrolyte disturbance, nephropathy.
Respiratory, thoracic and mediastinal disorders:
Pneumonia, acute or chronic interstitial alveolitis/pneumonia which can be fatal and is often associated with eosinophilia, acute pulmonary oedema, interstitial/pulmonary fibrosis, chronic interstitial obstructive pulmonary disease, pharyngitis, pleurisy, non- productive cough, thoracic pain, dyspnoea, pleural effusion, bronchial asthma, respiratory paralysis.
In the treatment of rheumatoid arthritis, Methotrexate induced lung disease is a potentially serious adverse drug reaction which may occur acutely at any time during therapy. It is not always fully reversible Epistaxis (frequency not known) has been reported.
Pulmonary alveolar haemorrhage (frequency not known) has been reported for methotrexate used in rheumatologic and related indications.
Nervous system disorders:
Headaches, fatigue, drowsiness, dizziness, vertigo, lethargy, aphasia, irritability, hemiparesis, paresis, convulsions, encephalopathy/leukoencephalopathy. Leukoencephalopathy has been reported especially following intravenous Methotrexate in high doses, or low doses following cranial-spinal radiation.
Cerebral oedema, transient subtle cognitive dysfunction, dysarthria, unusual cranial sensations. Pain, muscular asthenia , changes in sense of taste (metallic taste), meningism, acute aseptic meningitis, paralysis. Paraesthesia, hypoaesthesia (frequency very rare).
Psychiatric disorders:
Depression, confusion, mood […]
Deaths have been reported in association with the use of methotrexate in the treatment of psoriasis. Methotrexate should be used with extreme caution in the presence/history of infection, peptic ulcer, ulcerative colitis, debility, and in extreme youth and old age.
Use in patients with active gastrointestinal ulcer disease is contraindicated. If profound leukopenia occurs during therapy, bacterial infection may occur or become a threat. Cessation of the drug and appropriate antibiotic therapy is usually indicated.
In severe bone marrow depression blood or platelet transfusions may be necessary. Diarrhoea and ulcerative stomatitis are frequent toxic effects and require interruption of therapy, otherwise haemorrhagic enteritis and death from intestinal perforation may occur.
Following the occurrence of haematemesis, black coloured stools or blood in the stools, treatment must be discontinued. In addition other conditions leading to dehydration such as emesis, can increase the toxicity of methotrexate due to elevated levels of the active substance.
In these cases use of methotrexate should be interrupted until symptoms cease. It is important to determine any increase in active substance levels within 48 hours of therapy, otherwise irreversible methotrexate toxicity may occur. Because of the possibility of severe and even life-threatening toxic reactions the patient should be fully informed by the attending physician of the risks involved before onset of methotrexate treatment.
The patient should be closely monitored throughout the treatment. Patients should be informed of the signs and symptoms of toxicity, of the need to see their physician promptly if they occur, and the need for close follow-up, including regular laboratory tests for monitoring toxicity.
It should be emphasized to the patient treated for psoriasis that the recommended dose must be taken only once a week. The prescriber should specify the day of intake on the prescription. 9). Most adverse reactions are reversible if detected early.
When adverse reactions do occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken. If necessary, this includes the use of calcium folinate and/or acute, intermittent haemodialysis with high-flux dialyzer.
Methotrexate should be used with extreme caution in patients with psychiatric disorders. Patients with pleural effusions and ascites should be drained prior to initiation of methotrexate therapy or treatment should be withdrawn. Before beginning Methotrexate therapy or reinstituting Methotrexate after a rest period, a chest x-ray, assessment of renal function, liver function and blood elements should be made by history, physical examination and laboratory tests.
This will include a routine examination of lymph nodes and patients […]