Methotrexate should be used with caution in: patients with a stomach ulcer or ulcerative colitis (inflammation and ulceration of the gut); patients with kidney problems; patients with a medical condition which causes a build up of fluid in the lining of your lungs or in your abdomen (the fluid will need to be drained before methotrexate treatment is started); patients who are to have radiotherapy (risk of tissue and bone damage may be increased); patients who are to have any vaccinations (methotrexate can reduce the effect of vaccines); patients taking aspirin; patients who are also taking non-steroidal anti-inflammatory drugs (NSAIDs such as indometacin, ketoprofen) as well as low-doses of methotrexate.
It should not be used in: patients with significant kidney or liver problems; patients with a blood disorder e.g. low levels of white or red blood cells (anaemia), or platelets; patients with who are allergic (hypersensitivity) to methotrexate or any of the other ingredients; patients who are pregnant or are trying for a baby (both parents); patients who are breastfeeding; patients with an active infection (e.g. fevever, chills); patients who are also taking non-steroidal anti-inflammatory drugs (NSAIDs such as indometacin, ketoprofen) as well as high-doses of methotrexate.
Also see list of precautions and interactions.
There are no special storage instructions for the tablet formulation.
The vials should not be stored above 25°C (not refrigerated or frozen) and should be kept in the outer carton to provide protection from light.
What is it used for?
- Methotrexate is used to treat a number of problems.
- It is an antimetabolite medicine and an immunosuppressant.
- It is used to interfere with cell growth and to reduce the activity of the immune system.
- In general this drug is used to treat cancer, severe psoriasis (a skin disease with thickened patches of inflamed red skin, often covered by silvery scales). It is also used for patients who have tried other treatments but their illness has not improved.
Listed below are the typical uses of methotrexate:
- Cancer, including cancer of the ovary, head and neck cancer, breast cancer, cancer of the cervix, cancer of the bladder, non-Hodgkin's lymphomas (a cancer that begins in cells of the immune system)
- Prevention and treatment of various forms of leukaemia (a cancer that starts in the tissue that forms blood), such as meningeal leukaemia (that affects the membranes surrounding the brain and spinal cord) and acute lymphocytic leukaemias (a rapidly progressing form of leukaemia which has a sudden onset, that is characterised by the presence, in the blood and bone marrow, of large numbers of unusually immature white blood cells)
- Control and symptomatic treatment of severe psoriasis (an inflammatory skin disease characterised by recurring reddish patches covered with silvery scales) which is not responsive to other forms of therapy
- Control and symptomatic treatment of psoriatic arthritis (a form of arthriticjoint disease associated with the chronic skin scaling and fingernail changes seen in psoriasis)
- Treatment of chronic polyarthritis (rheumatoid arthritis)
- Treatment of choriocarcinoma (cancerous cells that turn into sperm and egg cells) and similar trophoblastic diseases (which affect the tissues that surround an embryo and which attach the embryo to the womb)
- Treatment of bronchogenic carcinoma (tumours in the lung)
- Treatment of osteosarcoma (malignant bone tumor).
- Treatment of mycosis fungoides (malignant tumour caused by fungus which causes inflammation of the skin)
On occasion your doctor may prescribe this medicine to treat a condition not on the above list. Such conditions are listed below:
HOW TO USE/TAKE
How often do I take it?
- Methotrexate should only be prescribed by doctors and administered by health professionals, who are familiar with the various characteristics of the drug and the way it works. The dose and how often you take the medication will depend on what conditions is being treated and how you have responded to other drugs. It is available in tablet form or as a solution for injection.
- If you are prescribed the tablet formation, take it by mouth, as prescribed by your doctor. Unless your doctor tells you otherwise, take plenty of water with this medication.
- Use this medication as prescribed by your doctor in order to get the most benefit from it.
- It may take some weeks before the full benefit of this drug takes effect.
- Certain medical conditions may require different dosage instructions as directed by your doctor.
- Dosage is based on your age, gender, medical condition, response to therapy, and use of certain interacting medicines.
Do I need to avoid anything?
- Methotrexate may make you feel drowsy or dizzy, therefore you may be advised not to drive or operate machinery if you do not feel well. Consult your doctor or pharmacist for more details.
When can I stop?
- Always complete the full course as prescribed by your doctor.
METHOTREXATE SIDE EFFECTS
- Pain in the stomach, loins or abdomen
- Ulcerative stomatitis (inflammation of the mucous tissue of the mouth with shallow ulcers on the cheeks, tongue, and lips)
- Leucopoenia (abnormally low number of white blood cells in the circulating blood)
- Itching or the appearance of lightened patches on the skin, bruises, boils
- Reduced appetite, feeling or being sick
- Jaundice (yellowing of the skin)
- Cystitis (you may need to pass urine more often than usual, which may be painful)
- Irregular periods in women (periods may stop completely)
- Eye irritation, blurred vision
- Difficulty with speech
- Muscle weakness
- Diabetes (you may feel the need to drink more than usual)
- Pain in your bones or abnormally easily broken bones (osteoporosis)
- Worsening of pre-existing rheumatoid arthritis
- Vasculitis (pain or redness of the blood vessels)
- Loss of libido/impotence
- Hair loss
- Enlarged glands/lymph nodes
- Unusual bleeding or bruising
- Black stools
- Skin rash
- Unusual pain and discoloration of the skin
If any of these persist or you consider them severe then inform your doctor or pharmacist.
Tell your doctor immediately if you develop any of the following symptoms: inflammation of the lung with breathlessness - you may develop a persistent cough; experience pain or difficulty breathing or become breathless; severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint; symptoms of an infection e.g. fever, chills, achiness, sore throat; unexpected bleeding e.g. bleeding gums; blood in the urine or in vomit; the appearance of unexpected bruises or broken blood vessels (broken veins); black tarry stools; a sore mouth, particularly if you have a number of ulcers or blisters inside of the mouth or on the tongue; skin rashes or blistering to the surfaces of the eyes, nose, vagina or anus (back passage).
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
The Yellow Card Scheme allows you to report suspected side effects from any type of medicine (which includes vaccines, herbals and over the counter medicines) that you are taking. It is run by the medicines safety watchdog called the Medicines and Healthcare products Regulatory agency (MHRA). Please report any suspected side effect on the Yellow Card Scheme website.
Before taking methotrexate, tell your doctor or pharmacist if you are allergic to it; or to other antimetabolites or immunosuppressant; or if you have any other allergies.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist in case of: liver disease, severe kidney disease; severe lung disease (e.g., pulmonary fibrosis); alcohol use; suppressed immune system; blood cell/bone marrow disorders; an active infection; pregnancy or intention to become pregnant, breastfeeding.
Before using this medication, tell your doctor or pharmacist your medical history, especially any of the following: stomach/intestinal diseases (e.g., peptic ulcer, ulcerative colitis); kidney or liver problems; any active infection (including chickenpox or recent exposure to it); folic acid deficiency; impaired respiratory (breathing) function; mild to moderate blood disorder; ulcers in the mouth, stomach or intestine (large bowel); ascites (collection of liquid in the free abdominal cavity) and/or pleural effusions (collection of liquid in the pleural cavity);
Before having surgery, tell your doctor or dentist that you are taking this medication.
Does alcohol intake affect this drug?
- You should avoid drinking alcohol before and after taking this drug.
The elderly: methotrexate should be used with extreme caution in the elderly as liver and kidney function as well as folate reserves decrease with increased age
Pregnancy and breastfeeding - please ensure you read the detailed information below
Methotrexate is not safe to take if you are, or are planning to become, pregnant.
It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.
If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.
Methotrexate is not safe to take if you are breastfeeding.
It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.
If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.
Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal products you may use, especially of:
- Non-steroidal anti-inflammatory medicines e.g. ibuprofen (medicines taken for pain relief)
- Aspirin or similar medicines (known as salicylates)
- Medicines taken to help control rheumatism e.g. leflunomide, azathioprine and sulphasalazine
- Omeprazole (medicine used to stop the production of stomach acid)
- Diuretics (water tablets)
- Medicines taken for diabetes (including insulin and tablets)
- Antibiotics such as penicillins, sulphonamides, co-trimoxazole, trimethoprim, tetracycline, chloramphenicol and para-aminobenzoic acid
- Phenytoin (medicine often used to treat epilepsy)
- Vitamin supplements containing folic acid
- Probenecid (medicine used to treat gout)
- Nitrous oxide (used for general anaesthesia and pain relief)
- Retinoids, such as acitretin (a medicine used to treat psoriasis) or isotretinoin (used to treat severe acne)
- Diphenylhydantoins (e.g. phenytoin, an antiepileptic agent)
- Barbiturates and tranquillisers (sedative agents)
- Cytostatics (medication against cancer), e.g. doxorubicin, mercaptopurine, procarbazine, cisplatin, L-asparaginase and 5-fluorouracil
- p-aminobenzoic acid (used in sun creams)
- p-aminohippuric acid (substance to check kidney function)
- Pyrimethamine (medication against malaria)
- Cholestyramine (lipid-lowering agent)
- Theophylline (used mainly in bronchial asthma)
- Erythrocyte concentrates (for blood transfusion)
- Sulphasalazine (for ulcerative colitis)
- Tetrahydrofolic acid preparations
- Hypoglycaemics (lower blood sugar levels)
- Other medicinal products with nephrotoxic and hepatotoxic potential (including alcohol)
- Azathioprine (an immunosuppressive drug)
This information does not contain all possible interactions. Therefore, before using methotrexate, tell your doctor or pharmacist of all the products you use.
An overdose of methotrexate will mainly affect the haematopoietic system, which is responsible for forming blood. An overdose can be treated with calcium folinate, which neutralises the effects of methotrexate toxicity.
If you think you, or someone you care for, might have accidentally taken more than the recommended dose of methotrexate or intentional overdose is suspected, contact your local hospital, GP or if in England call 111. In Scotland call NHS 24. In Wales, call NHS Direct Wales. In the case of medical emergencies, always dial 999.
If you miss a dose, do not double the dose to catch up. Contact your doctor or pharmacist immediately to establish a new dosing schedule.