Febuxostat

Pronunciation

Generic Name: febuxostat (fe-BUX-oh-stat)
Brand Name: Uloric

Febuxostat is used for:

Long-term treatment of high blood uric acid levels in patients with gout.

Febuxostat is a xanthine oxidase inhibitor. It works by blocking an enzyme in the body (xanthine oxidase), which lowers levels of uric acid in the blood. This helps to prevent gout flare-ups.

Do NOT use febuxostat if:

  • you are allergic to any ingredient in febuxostat
  • you do not have symptoms caused by high blood uric acid levels
  • you have high blood uric acid levels caused by a condition other than gout (eg, Lesch-Nyhan syndrome, cancer or treatment of cancer, organ transplant)
  • you are taking azathioprine, didanosine, or mercaptopurine

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

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Before using febuxostat:

Some medical conditions may interact with febuxostat. 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 breast-feeding
  • 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 liver or kidney problems
  • if you have a history of heart problems (eg, a heart attack) or a stroke

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

  • Azathioprine, didanosine, mercaptopurine , and theophylline because the risk of their side effects may be increased by febuxostat

This may not be a complete list of all interactions that may occur. Ask your health care provider if febuxostat 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 febuxostat:

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

  • An extra patient leaflet is available with febuxostat. Talk to your pharmacist if you have questions about this information.
  • Take febuxostat by mouth with or without food.
  • Continue to take febuxostat even if you feel well. Do not miss any doses.
  • If you miss a dose of febuxostat, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

  • Some patients may experience a gout flare-up when they start taking febuxostat. Your doctor may prescribe a nonsteroidal anti-inflammatory drug (NSAID) or colchicine to take to help control or prevent a gout flare-up. If you experience a gout flare-up, do not stop taking febuxostat without talking to your doctor. Talk with your doctor if you have any questions or concerns.
  • Lab tests, including uric acid levels and liver function, may be performed while you take febuxostat. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Febuxostat should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking febuxostat while you are pregnant. It is not known if febuxostat is found in breast milk. If you are or will be breast-feeding while you take febuxostat, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of febuxostat:

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:

Joint pain; nausea.

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; unusual hoarseness); blood in the urine or stools; chest, jaw, or arm pain; confusion; coughing or vomiting blood; decrease in the amount of urine produced; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hearing loss; mental or mood changes; muscle pain or cramps; one-sided weakness; red, swollen, blistered, or peeling skin; shortness of breath; sudden, severe nausea or vomiting; symptoms of high or low blood pressure (eg, headache, dizziness, tiredness, weakness); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; right-sided stomach pain; loss of appetite; unusual nausea or tiredness); slurred speech; stomach pain; unusual bruising or bleeding; unusual sweating or weakness; vision problems (eg, blurred vision).

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 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, or emergency room immediately.

Proper storage of febuxostat:

Store febuxostat at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep febuxostat out of the reach of children and away from pets.

General information:

  • If you have any questions about febuxostat, please talk with your doctor, pharmacist, or other health care provider.
  • Febuxostat 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 should not be used to decide whether or not to take febuxostat or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about febuxostat. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to febuxostat. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using febuxostat.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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