Loading…
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 recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients.
Verbatim from this product's MHRA label. Tap a section to expand.
Important warning about the dosage of Methotrexate tablets (methotrexate):
In the treatment of rheumatic diseases or diseases of the skin requiring dosing once a week, Methotrexate tablets (methotrexate) must only be taken once a week. Dosage errors in the use of Methotrexate tablets (methotrexate) can result in serious adverse reactions, including death.
Please read this section of the summary of product characteristics very carefully. Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy.
Methotrexate is given once weekly. It must be explicitly pointed out to the patient that methotrexate is applied only once a week. The prescriber should specify the day of intake on the prescription. The prescriber should ensure that patients or their carers will be able to comply with the once weekly regimen.
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. 5 mg once a week.
5 mg tablets can be used for this dose. If the dose had to be increased, that is 10 mg per week, then the packaging of Methotrexate 10 mg tablets containing 10 tablets would be used. The distribution is given as below. 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 occur with increased age.
Generally the frequency and severity of adverse reactions are dependent of the size of the dose, the dosing frequency, the method of administration and the duration of exposure. 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.
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. 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 (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). Very Common Common Uncommon Rare Very Rare Not known Infections and infestations Infections Opportunistic infections Herpes zoster Sepsis Sepsis resulting in death Reactivation of inactive chronic infection Neoplasms benign,malign ant and unspecified (including cysts and polyps) Lymphoma1 Blood and lymphatic system disorders Leucopaenia Bone marrow depression Agranulocytosis Thrombocytopae niaAnaemia Hematopoietic disorders Megaloblastic anemia Hypogammag lobulinaemia, Lymphoprolif erative disorders (see “description” below the table) Lymphadeno- pathy Neutropenia Aplastic anemia Pancytopenia, eosinophilia Immune system disorders Anaphylactic- type reaction Immuno- suppression Anaphylactic shock Allergic reactions Endocrine disorders Diabetes mellitus Psychiatric disorders Depression Confusion Mood alterations Insomnia Psychoses Nervous system disorders Headache Drowsiness Dizziness Fatigue Vertigo Hemiparesis Paresis Irritation Dysarthria Aphasia Lethargy Cerebral oedema, Transient subtle cognitive dysfunction Unusual cranial sensations Convulsions Pain, muscular asthenia or paraesthesia in the extremities Paraesthsia/hy poaesthesia Changes in sense of taste (metallic taste) Meningism Acute aseptic meningitis Paralysis Encephalopath y/ Leuko- encephalopath y Eye disorders Conjunctivitis Blurred vision Impaired vision Retinopathy Ear and labyrinth disorders Tinnitus Cardiac disorders Pericarditis Pericardial effusion Pericardial tamponade Vascular disorders Hypotension Thromboemboli sm Vasculitis Respiratory, thoracic and mediastinal disorders Pneumonia Interstitial pneumonitis Interstitial/ pulmonary fibrosis Dyspnoea Pharyngitis2 Respiratory paralysis Pneumocystis jiroveci – pneumonia and other lung infections Chronic interstitial obstructive lung disease Pleuritis Pleural effusion Dry cough Interstitial alveolitis4 Epistaxis Bronchial asthma Pulmonary alveolar haemorrhage Gastrointestin al disorders3 Stomatitis Dyspepsia Anorexia Nausea Vomiting Abdominal pain oral ulcer Diarrhoea Gingivitis Gastrointestinal ulcerations and haemorrhage Enteritis Melaena Haematemesis Toxic megacolon Pancreatitis Hepatobiliary disorders Abnormal liver function tests (increased ALAT, ASAT, alkaline phosphatase and bilirubin) Decrease in serum albumin Fatty degeneration of the liver Hepatotoxicity Periportal fibrosis Liver cirrhosis Acute hepatitis Reactivation of chronic hepatitis Hepatic failure Skin and subcutaneous tissue disorders Erythematous rash Alopaecia Exanthema Pruritus Stevens- Johnson´s syndrome Toxic epidermal necrolysis Herpetiform eruptions of the skin Increased skin pigmentation photosensitivity reactions Acne Depigmentation Urticaria Erythema multiforme Painful damage to psoriatic lesion Skin ulceration Onycholysis Increased nail pigment changes Petechiae Allergic vasculitis Telangiectasis Furunculosis Ecchymoses Hidradenitis Acute paronchynia Skin exfoliation/der matitis exfoliative Radiation dermatitis and sunburn may be “recalled” Musculoskele tal and connective tissue disorders Osteoporosis Arthralgia Myalgia Increased rheumatic nodules Stress fracture Osteonecrosis of jaw (secondary to lymphoprolifer ative disorders) Renal and urinary disorders Renal insufficiency Nephropathy Inflammation and ulceration of the urinary bladder Disturbed micturition Dysuria Oliguria Anuria Electrolyte disturbances Azotaemia Haematuria Proteinuria Pregnancy, puerperium and perinatal conditions Miscarriage, fetal damages Reproductive system and breast disorders Vaginal inflammation and ulceration Decreased libido Impotence Menstrual disorders Formation of defective oocytes or sperm cells Transient oligospermia, infertility Vaginal bleeding Vaginal discharge Gynaecomasti a General disorders and administration site conditions Chills Fever Wound-healing impairment Asthenia Oedema Injury, poisoning and procedural complications Increased risk of toxic reactions (soft tissue necrosis, osteonecrosis) during radiotherapy, The psoriatic lesions may get worse from simultaneous exposure to methotrexate and ultraviolet radiation.
Dosing in the treatment of rheumatoid arthritis, psoriasis and psoriatic arthritis: The patients should be informed clearly that in the treatment of psoriasis and rheumatoid arthritis the administration is once weekly. The prescriber should specify the day of intake on the prescription.
The prescriber should make sure patients understand that Methotrexate tablets (methotrexate) should only be taken once a week. Patients should be instructed on the importance of adhering to the once-weekly intakes. Warnings Methotrexate must be used only by physicians experienced in antimetabolite chemotherapy.
g. leflunomide) is not advisable. 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. 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). 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), thoracic pain 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.
6) • During methotrexate therapy concurrent vaccination with live vaccines must not be carried out. • Stomatitis, ulcers of the oral cavity and known active gastrointestinal ulcer disease
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Methotrexate in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Renal impairment Methotrexate should be used with caution in patients with impaired renal function. 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.
1. 4). 2. 4. 3. Gastrointestinal […]
If methotrexate induced lung disease is suspected treatment with corticosteroids should be initiated and treatment with methotrexate should not be restarted. 5 mg /week). In addition, pulmonary alveolar haemorrhage has been reported with methotrexate used in rheumatologic and related indications.
This event may also be associated with vasculitis and other comorbidities. Prompt investigations should be considered when pulmonary alveolar haemorrhage is suspected to confirm the diagnosis. Deaths have been reported associated with the use of methotrexate in the treatment of psoriasis.
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 the diagnosis has been established by biopsy and/or after dermatological consultation.
Full blood counts should be closely monitored before, during and after treatment. If a clinically significant drop in white-cell or platelet count develops, methotrexate should be withdrawn immediately. Patients should be advised to report all symptoms or signs suggestive of infection.
Methotrexate may be hepatotoxic, particularly at high doses or with prolonged therapy. Liver atrophy, necrosis, cirrhosis, fatty changes, and periportal fibrosis have been reported. Since changes may occur without previous signs of gastrointestinal or haematological toxicity, it is imperative that hepatic function be determined prior to initiation of treatment and monitored regularly throughout therapy.
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. 5). Closer monitoring of liver enzymes should be undertaken in patients concomitantly taking other hepatotoxic medicinal products.
Increased […]