Generic Methotrexate, tablets

Chemical Name: METHOTREXATE

Common uses

This medicine is an antimetabolite used to treat certain types of cancer or to control severe psoriasis or rheumatoid arthritis. This medicine works by interfering with cell growth and by suppressing the immune system. Early treatment of rheumatoid arthritis with more aggressive therapy such as methotrexate helps to reduce further joint damage and to preserve joint function. This medicine may also be used to treat other conditions as determined by your doctor, including lupus and psoriatic arthritis.

Before using

Warning: rarely, methotrexate has caused serious (possibly fatal) side effects. This medicine should be used only to treat cancer or severe cases of psoriasis or rheumatoid arthritis. Methotrexate has caused birth defects and fetal death. Women must avoid becoming pregnant while taking this medicine. Pregnant women who have psoriasis or rheumatoid arthritis must not use methotrexate. (see cautions) if you have kidney problems/excess body water (ascites, pleural effusion), you must be monitored and your dose may be adjusted or stopped by your doctor. Infrequently, methotrexate (usually at high dosages) has caused severe (possibly fatal) bone marrow suppression (decreasing your body's ability to fight infection) and stomach/intestinal disease (e.g., bleeding) when used with nonsteroidal anti-inflammatory medicines (nsaids) (e.g., ibuprofen, naproxen). This medicine may rarely cause liver problems when used for long periods of time. If you are using methotrexate long-term, liver biopsies should be performed. Rarely, methotrexate use has resulted in serious (possibly fatal) lung problems/infections (pneumocystis carinii pneumonia), skin reactions, diarrhea and mouth sores (ulcerative stomatitis). (see side effects) very rarely, lumps (tumors/abnormal growths) may appear during methotrexate use. The drug must be stopped and treatment may be needed. Consult your doctor immediately if new lumps/growths occur. When used to treat tumors, methotrexate may cause side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). Tell your doctor immediately if you experience symptoms such as irregular heartbeat or muscle weakness. Although rare, this medicine when used with radiation therapy may increase the risk of tissue/bone damage. Discuss the risks/benefits of your treatment with your doctor.

Inform your doctor or pharmacist of all prescription and over-the-counter medicine you take. Do not take this medicine if you also take acitretin, asparaginase, live vaccines, nsaids with high-dose methotrexate therapy for certain cancers, or pyrimethamine.

Additional monitoring of your dose or condition may be needed if you take aspirin/nsaids, cancer treatments possibly toxic to the kidney (e.g., cisplatin), digoxin, leflunomide, medicines possibly toxic to the liver (e.g., azathioprine, sulfasalazine, isotretinoin), penicillins, phenytoin, probenecid, procarbazine, sulfa medicines, or theophylline. Do not start or stop any medicine without doctor or pharmacist approval. Inform your doctor of other medical conditions including stomach/intestinal disease (e.g., peptic ulcer, ulcerative colitis), kidney disease, active infection (including chickenpox or recent exposure to it), folic acid deficiency, allergies, pregnancy, or breast-feeding.

Use of this medicine is not recommended if you have liver disease, severe kidney/lung disease (e.g., pulmonary fibrosis), alcohol use, suppressed immune system, or blood cell/bone marrow disorders.

Directions

Follow the directions for using this medicine exactly as provided by your doctor. This medicine may come with a patient information leaflet. Ask your doctor, nurse, or pharmacist any questions you have about this medicine. This is a potent medicine. The dose and how often you take it is based on your medical condition and response to therapy. There are many different dosing schedules for this medicine (especially for cancer treatment). Therefore, it is very important that you follow your doctor's instructions carefully. Take it by mouth exactly as directed. Do not exceed the recommended dose or take this medicine for longer than prescribed without checking with your doctor. Your condition will not improve any faster and the risk of serious side effects may be increased. For managing psoriasis or rheumatoid arthritis, take this medicine exactly as directed, usually once a week. Drinking extra fluids while you are taking this medicine is recommended. This helps your kidneys to remove the drug from your body and minimize some of the side effects. Check with your doctor or nurse for instructions. If nausea, vomiting, or loss of appetite occur, ask your doctor, nurse, or pharmacist for ways to lessen these effects.

Store this medicine at room temperature between 59 and 86 degrees f (15-30 degrees c) in a tightly-closed container, away from light, and moisture. It is important to use each dose at the scheduled time. If you miss a dose of this medicine, contact your doctor or pharmacist. Do not take 2 doses at once.

Cautions

It may take several months of continued use for the full benefit of this medicine to be seen in the management of psoriasis or rheumatoid arthritis. Do not stop using this medicine without checking with your doctor. Keep all doctor and laboratory appointments while you are using this medicine. Laboratory and/or medical tests (e.g., cbc, liver and kidney function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Certain antibiotics (e.g., chloramphenicol, sulfa, tetracyclines) may interfere with methotrexate blood tests (increase methotrexate blood levels due to protein-binding displacement). Make sure laboratory personnel and your doctors know you are using any of these types of antibiotics.

This medicine may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Do not drink alcohol while you are taking this medicine. This medicine may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to this medicine. Use a sunscreen or protective clothing if you must be outside for a prolonged period.

This medicine may reduce the number of blood cells which are needed for clotting. To prevent bleeding use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports to lower the chance of getting cut, bruised or injured. This medicine may lower your resistance to infection. Wash your hands well to prevent the spread of infections. Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine. Certain side effects, such as mouth sores, may be reduced by taking a folic acid supplement. Talk with your doctor or pharmacist about the use of folic acid supplements to determine if one is right for you.

Before you begin taking any new medicine, either prescription or over-the-counter, check with your doctor or pharmacist. This includes any medicines that contain ibuprofen, naproxen, aspirin, salicylates, or any other medicine used to treat pain, fever, swelling, or arthritis. For both men and women, use an effective form of birth control during therapy and for up to 3 months after this medicine is stopped. Do not use this medicine if you are pregnant. It may cause fetal harm. If you suspect that you could be pregnant, contact your doctor immediately. This medicine is excreted in breast milk. Do not breast-feed while taking this medicine.

Possible side effects

Side effects, that may go away during treatment, include nausea, vomiting, stomach pain, drowsiness or dizziness. If they continue or are bothersome, check with your doctor promptly. Contact your doctor immediately if you experience any of these serious side effects including mouth sores, diarrhea, fever, fatigue, persistent sore throat, unusual bleeding or bruising, black stools, skin rash, enlarged glands/lymph nodes, dark urine, bone pain, or unusual pain and discoloration of the skin. Contact your doctor immediately if you experience any of these unlikely but serious side effects including, yellowing of the eyes/skin, change in the amount of urine, chest pain, dry cough, trouble breathing, calf pain/swelling, vision changes, irregular heartbeat, muscle weakness, mental changes, or seizures. Temporary hair loss may occur. Normal hair growth should return after treatment has ended. An allergic reaction to this medicine is unlikely but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist (see also before using section).

If you take too much

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe nausea and vomiting, and bloody stools.

Additional information

Carry an identification card at all times that says you are taking this medicine. Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children and pets. If using this medicine for an extended period of time, obtain refills before your supply runs out.

Drug interactions

Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Some medicines or medical conditions may interact with this medicine. Inform your doctor or pharmacist of all prescription and over-the-counter medicine that you are taking.