Thursday, October 6, 2016

Methotrexate Tablets



Pronunciation: METH-oh-TREX-ate
Generic Name: Methotrexate
Brand Name: Examples include Rheumatrex and Trexall

Methotrexate may cause severe and sometimes fatal side effects. These may include bone marrow, blood, liver, lung, kidney, or skin problems. For this reason, Methotrexate is only used to treat certain patients who have life-threatening cancer or who have severe psoriasis or rheumatoid arthritis that is not relieved by other treatments. Your doctor will perform lab tests to check for side effects while you take Methotrexate. Keep all doctor and laboratory appointments. Talk with your doctor and be sure you understand the risks and benefits of using Methotrexate.


Methotrexate may cause birth defects or fetal death. Do not use Methotrexate to treat psoriasis or rheumatoid arthritis if you are pregnant. Tell your doctor before you take Methotrexate if you are pregnant or think you may be pregnant. Do not become pregnant or father a child while using Methotrexate. Talk to your doctor about using an effective form of birth control.


Certain medicines and conditions may increase your risk for side effects. Tell your doctor if you take a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, celecoxib) or salicylate (eg, aspirin), or if you receive radiation therapy. Tell your doctor if you have excess fluid in your stomach or around your lungs, or if you have any liver, kidney, lung, blood, bone marrow, stomach, bowel, or immune system problems. Tell your doctor right away if you develop any new or worsening symptoms, including black, tarry stools; dry, nonproductive cough; mouth sores; red, swollen, blistered, or peeling skin; severe or persistent diarrhea or vomiting; shortness of breath or trouble breathing; signs of infection (eg, fever, chills, persistent sore throat); stomach pain; unusual bruising or bleeding; unusual tiredness or weakness; or yellowing of the skin or eyes.


Methotrexate may cause a serious and possibly fatal condition called tumor lysis syndrome (TLS) in certain patients with cancer. Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness.


Methotrexate may increase the risk of developing a certain type of cancer (lymphoma). Discuss any questions or concerns with your doctor.





Methotrexate is used for:

Treating certain types of cancer. It is also used to control severe psoriasis and severe rheumatoid arthritis in certain patients. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.


Methotrexate is an antimetabolite. It works to treat cancer and psoriasis by slowing the growth of cancer cells and abnormal skin cells. Exactly how Methotrexate works to treat rheumatoid arthritis is unknown. It reduces symptoms of inflammation (eg, pain, swelling, stiffness) caused by rheumatoid arthritis.


Do NOT use Methotrexate if:


  • you are allergic to any ingredient in Methotrexate

  • you are breast-feeding

  • you are treating psoriasis or rheumatoid arthritis and any of the following apply to you:
    • you are pregnant

    • you have alcoholism, liver problems caused by alcohol, or chronic liver problems

    • you have a weakened immune system or certain blood problems (eg, anemia, bone marrow depression, low white blood cell count, low blood platelet count)


  • you are taking acitretin

  • you have taken or will be taking palifermin within 24 hours of taking Methotrexate

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 pregnant, planning to become pregnant, or are breastfeeding

  • 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 are able to become pregnant or father a child

  • if you have a history of lung problems, immune system problems, nervous system problems (eg, seizures), liver problems (eg, hepatitis), kidney problems, diabetes, or blood problems (eg, anemia, low white blood cell levels, low blood platelet levels)

  • if you have an active infection, severe vomiting or diarrhea, or dehydration

  • if you have mouth sores, excess fluid in your stomach or around your lungs, stomach or bowel ulcers, bowel inflammation (eg, ulcerative colitis), or a blockage of your stomach or bowel

  • if you have a folic acid deficiency, are in very poor health or are very overweight, or have a history of alcohol abuse

  • if you are receiving chemotherapy or radiation

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


  • Palifermin because if mouth or tongue sores develop, they may be more severe or last longer

  • Medicines that may harm the kidney (eg, amphotericin B; tacrolimus; aminoglycoside antibiotics such as gentamicin) or the liver (eg, azathioprine; retinoids such as acitretin or isotretinoin; acetaminophen; ketoconazole; isoniazid; certain medicines for HIV infection) because the risk of kidney or liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney or liver

  • Chloramphenicol, ciprofloxacin, corticosteroids (eg, prednisone), cyclosporine, dantrolene, hydantoins (eg, phenytoin), hydroxychloroquine, leflunomide, NSAIDs (eg, ibuprofen, celecoxib, ketorolac), penicillamine, penicillin antibiotics (eg, amoxicillin), phenylbutazone, pristinamycin, probenecid, proton pump inhibitors (PPIs) (eg, omeprazole), salicylates (eg, aspirin), sulfonamide medicines (eg, sulfamethoxazole, sulfasalazine), tetracycline antibiotics (eg, doxycycline), trimethoprim, or vancomycin because they may increase the risk of Methotrexate's side effects

  • Folic acid because it may decrease Methotrexate's effectiveness

  • Digoxin because its effectiveness may be decreased by Methotrexate

  • Mercaptopurine, oral anticoagulants (eg, warfarin), or theophylline because the risk of their 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. However, you should take it the same way each time in relation to food.

  • Drinking extra fluids while you are taking Methotrexate is recommended. Check with your doctor for instructions.

  • The dose of Methotrexate and how often you use it are based on your medical condition and response to treatment. It is very important that you follow your doctor's instructions carefully. Taking too much of Methotrexate may cause serious and sometimes fatal side effects. Be sure you understand exactly how much of Methotrexate to take and how often you should take it. Ask your doctor or pharmacist if you have any questions.

  • It may take several weeks 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.

  • Methotrexate works best if each dose is taken at the scheduled time.

  • Continue to take Methotrexate even if you feel well. Do not miss any doses.

  • If you miss a dose of Methotrexate, contact your doctor right away. 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, dizziness, or blurred vision. 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.

  • Check with your doctor before you drink alcohol while you are taking Methotrexate.

  • Nausea, vomiting, and loss of appetite are common with Methotrexate. Ask your doctor or pharmacist for ways to decrease these effects if they occur.

  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.

  • 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.

  • Methotrexate may affect your ability to become pregnant or to father a child. Discuss any questions or concerns with your doctor.

  • Men who take Methotrexate should always use a condom when having sex with a woman who may become pregnant. Do this for as long as you take Methotrexate and for 3 months after you stop taking it.

  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

  • Lab tests, including complete blood cell counts, liver function, and kidney function, 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 be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Methotrexate may cause birth defects and fetal or newborn death if you take it while you are pregnant. Do not become pregnant while you are using it. Use an effective form of birth control while you take Methotrexate and for at least 1 ovulatory cycle after you stop taking it. 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:



Dizziness; drowsiness; general body discomfort; headache; loss of appetite; mild hair loss; mild stomach pain; nausea; tiredness.



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, tarry stools; blood in the urine; bone pain; calf or leg pain, redness, swelling, or tenderness; change in the amount of urine produced; chest pain; confusion; coughing up blood; diarrhea or vomiting; difficult or painful urination; dry cough; enlargement of the breasts (in males); fainting; fever, chills, or persistent sore throat; menstrual changes; mental or mood changes; mouth or tongue sores or swelling; muscle weakness; night sweats; one-sided weakness; red, swollen, peeling, or blistered skin; seizures; severe or persistent dizziness or light-headedness; shortness of breath; speech changes; swollen glands; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, severe stomach pain, yellowing of the skin or eyes); symptoms of pancreas inflammation (eg, severe stomach pain with or without nausea or vomiting); unexplained weight loss; unusual bleeding or bruising; unusual pain and discoloration of the skin; unusual tiredness or weakness; vaginal discharge; vision loss or other vision changes (eg, blurred vision); vomit that looks like coffee grounds.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Methotrexate side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black or bloody stools; change in the amount of urine produced; seizures; severe headache, nausea, vomiting, or stomach pain; swelling or soreness of the mouth or tongue; unusual bruising or bleeding; unusual tiredness or weakness; vomit that looks like coffee grounds.


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.

  • Check with your pharmacist about how to dispose of unused medicine.

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: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Methotrexate resources


  • Methotrexate Side Effects (in more detail)
  • Methotrexate Dosage
  • Methotrexate Use in Pregnancy & Breastfeeding
  • Drug Images
  • Methotrexate Drug Interactions
  • Methotrexate Support Group
  • 42 Reviews for Methotrexate - Add your own review/rating


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