Methotrexate Tablets

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Methotrexate


Generic Name: Methotrexate Tablets (meth-oh-TREK-sate)
Brand Name: Examples include Trexall and Rheumatrex

Rarely, methotrexate has caused serious (possibly fatal) side effects. Methotrexate 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 Methotrexate. Pregnant women who have psoriasis or rheumatoid arthritis must not use methotrexate. 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 (eg, bleeding) when used with nonsteroidal anti-inflammatory medicines (eg, ibuprofen, naproxen). Methotrexate 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 (eg, Pneumocystis carinii pneumonia), skin reactions, diarrhea, and mouth sores (eg, ulcerative stomatitis). 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 you doctor immediately if you experience symptoms such as irregular heartbeat or muscle weakness. Although rare, when used with radiation therapy, Methotrexate may increase the risk of tissue/bone damage. Discuss the risks/benefits of your treatment with your doctor.


Methotrexate is used for:

Treating certain types of cancer. It is also used to control severe psoriasis and severe rheumatoid arthritis.

Methotrexate is an antimetabolite that blocks an enzyme important in DNA synthesis. This slows the rate of cell production and development in tissues, which are growing at an abnormally fast rate. How Methotrexate works in rheumatoid arthritis is not completely understood. It may suppress the immune system, which produces chemicals causing inflammation (eg, swelling, pain, stiffness, warmth) of rheumatoid arthritis.

Do NOT use Methotrexate if:

  • you are allergic to any ingredient in Methotrexate
  • you have anemia or another blood disease, low white cell count or low platelet count in your blood, or bone marrow depression
  • you have alcoholism, alcoholic liver disease, or chronic liver disease
  • you have severe kidney disease
  • you are pregnant or are breast-feeding
  • you are taking acitretin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Methotrexate:

Some medical conditions may interact with Methotrexate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are planning to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have fluid in your stomach; excess fluid around your lungs; an obstruction of your intestines or colon; liver disease; a suppressed immune system; an infection; a swelling, irritation, or ulceration of your digestive tract; kidney disease; nausea or vomiting; a folic acid deficiency; a peptic ulcer; chickenpox; shingles; or ulcerative colitis
  • if you are receiving chemotherapy or radiation, abuse alcohol, or are debilitated

Some MEDICINES MAY INTERACT with Methotrexate. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen) because the risk of side effects, some possibly fatal, may be increased
  • Certain medicines that can cause liver problems (eg, acitretin, azathioprine, sulfasalazine) because they may increase the risk for liver problems with Methotrexate
  • Corticosteroids (eg, prednisone), cyclosporine, hydantoins (eg, phenytoin), many antibiotics (eg, chloramphenicol, neomycin, penicillin, tetracycline, trimethoprim/sulfamethoxazole), phenylbutazone, probenecid, or salicylates (eg, aspirin) because they may increase the risk of side effects
  • Vitamins containing folic acid because they may decrease Methotrexate"s effectiveness
  • Cyclosporine, oral anticoagulants (eg, warfarin), or theophylline because side effects may be increased by Methotrexate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Methotrexate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Methotrexate:

Use Methotrexate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Methotrexate by mouth with or without food.
  • Drinking extra fluids while you are taking Methotrexate is recommended. Check with your doctor for instructions.
  • This is a potent medicine. The dose and how often your take it are based on your medical condition and response to therapy. There are many different dosing schedules for Methotrexate (especially for cancer treatment). Therefore, it is very important that you follow your doctor"s instructions carefully. Take Methotrexate by mouth exactly as directed.
  • It may take several months of continued use for the full benefit of Methotrexate to be seen in the management of psoriasis or rheumatoid arthritis. Do not stop taking Methotrexate without checking with your doctor.
  • It is important to use each dose at the scheduled time. If you miss a dose of Methotrexate, contact your doctor or pharmacist. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Methotrexate.

Important safety information:

  • Methotrexate may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Methotrexate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • If nausea, vomiting, or loss of appetite occurs, ask your doctor or pharmacist for ways to lessen these effects.
  • Do not drink alcohol while you are using Methotrexate.
  • Methotrexate may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Methotrexate. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Methotrexate may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Methotrexate may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Methotrexate. Talk with your doctor before you receive any vaccine.
  • Certain side effects (eg, 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.
  • Certain antibiotics (eg, chloramphenicol, sulfa, tetracyclines) may interfere with methotrexate blood tests. Be sure your doctor and lab personnel know you are using any of these types of antibiotics.
  • Use an effective form of birth control during therapy and for up to 3 months after Methotrexate is stopped. Fetal harm can occur if conception occurs while a male or female is taking Methotrexate.
  • Lab tests, including, liver function, kidney function, and complete blood cell counts, may be performed while you use Methotrexate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Methotrexate with caution in the ELDERLY; they may be more sensitive to its effects.
  • Methotrexate should not be used in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Methotrexate may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. Methotrexate is found in breast milk. Do not breast-feed while taking Methotrexate.

Possible side effects of Methotrexate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; chills and fever; dizziness; flushing; general body discomfort; hair loss; headache; infertility; irregular periods; itching; loss of appetite; lowered resistance to infection; miscarriage; nausea; sensitivity to sunlight; sore throat; speech impairment; stomach pain; stomach ulcers; swelling of the breast; unusual tiredness; vaginal discharge; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black stools; blood in the urine; bone pain; calf pain/swelling; change in amount of urine; chest pain; dark urine; diarrhea; dry cough; enlarged glands; fatigue; inflammation of the pancreas (stomach tenderness, nausea, vomiting, fever, increased pulse rate); irregular heartbeat; mental changes; mouth sores; muscle weakness; persistent sore throat; seizures; serious infection (herpes, hepatitis, blood infection); trouble breathing; unusual bleeding or bruising; unusual pain and discoloration of the skin; vision changes; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include bloody stools; severe nausea; vomiting.

Proper storage of Methotrexate:

Store Methotrexate at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Methotrexate out of the reach of children and away from pets.

General information:

  • If you have any questions about Methotrexate, please talk with your doctor, pharmacist, or other health care provider.
  • Methotrexate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Methotrexate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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