Zileuton

Generic Name: Zileuton (zye-LOO-ton)Brand Name: Zyflo

Zileuton is used for:

Preventing and treating asthma in patients 12 years old and older. It may also be used for other conditions as determined by your doctor.

Zileuton is a leukotriene synthesis inhibitor. It works by blocking the formation of a substance called leukotriene, which helps to decrease certain asthma and allergy symptoms.

Do NOT use Zileuton if:

  • you are allergic to any ingredient in Zileuton
  • you have liver disease or abnormal liver function tests
  • if you are taking an H1 antagonist (eg, astemizole, terfenadine) or pimozide

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

Before using Zileuton :

Some medical conditions may interact with Zileuton . 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 a history of liver problems (eg, hepatitis) or symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine)
  • if you have a history of mental or mood problems (eg, depression) or suicidal thoughts or actions
  • if you drink alcohol

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

  • Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
  • Azole antifungals (eg, ketoconazole) because they may increase the risk of Zileuton 's side effects
  • Beta-blockers (eg, propranolol), calcium channel blockers (eg, amlodipine), cisapride, cyclosporine, H1 antagonists (eg, astemizole, terfenadine), pimozide, or theophylline because the risk of their side effects may be increased by Zileuton

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

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

  • An extra patient leaflet is available with Zileuton . Talk to your pharmacist if you have questions about this information.
  • Take Zileuton by mouth with or without food.
  • Take Zileuton on a regular schedule to get the most benefit from it. Taking Zileuton at the same times each day will help you remember to take it.
  • Continue to take Zileuton even if you feel well. Do not miss any doses.
  • If you miss a dose of Zileuton , 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 Zileuton .

Important safety information:

  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • It may take a few weeks before you get the full benefit of Zileuton . Do not stop using Zileuton without checking with your doctor.
  • Zileuton will not stop an asthma attack once it has already started. Be sure to carry a short-acting bronchodilator with you at all times to treat any breathing problems that may occur between doses of Zileuton (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop asthma attacks, check with your doctor or pharmacist.
  • Tell your doctor at once if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it more often, or if you have a decrease in your peak flow meter results.
  • Contact your doctor or seek medical care right away if you have breathing problems that worsen quickly, or if you use your short-acting bronchodilator and do not get relief.
  • Talk with your doctor or pharmacist about all your asthma medicines and how to use them. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.
  • Contact your doctor at once if you develop upper stomach pain, severe or persistent nausea, unusual tiredness or fatigue, yellowing of the eyes or skin, dark urine, pale stools, fever, or flu-like symptoms. These may be signs of liver problems.
  • Some patients taking Zileuton have developed mental or mood changes, including suicidal thoughts or actions. Contact your doctor immediately if you experience symptoms such as agitation, aggression, hostility, anxiety, depression, strange dreams, trouble sleeping, sleepwalking, tremor, hallucinations, restlessness, irritability, or any unusual change in mood or behavior. Contact your doctor immediately if any signs of suicidal thoughts or actions occur.
  • Lab tests, including liver function, may be performed while you take Zileuton . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Zileuton with caution in the ELDERLY; they may be more sensitive to its effects, especially liver toxicity.
  • Zileuton should be used with extreme caution in CHILDREN younger than 12 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 using Zileuton while you are pregnant. It is not known if Zileuton is found in breast milk. Do not breast-feed while taking Zileuton .

Possible side effects of Zileuton :

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:

Nausea; stomach pain or upset.

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); chest pain; dark urine; fever, chills, or persistent sore throat; flu-like symptoms; mental or mood changes (eg, agitation, aggression, hostility, anxiety, depression, strange dreams, sleepwalking, tremor, hallucinations, restlessness, irritability); pale stools; right upper stomach pain; severe or persistent nausea or stomach pain; suicidal thoughts or actions; trouble sleeping; unusual changes in behavior; unusual tiredness or weakness; yellowing of the skin or eyes.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately.

Proper storage of Zileuton :

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

General information:

  • If you have any questions about Zileuton , please talk with your doctor, pharmacist, or other health care provider.
  • Zileuton 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 Zileuton . 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.

  • Zileuton Professional Patient Advice (Wolters Kluwer)
  • Zileuton Detailed Consumer Information (PDR)
  • zileuton Advanced Consumer (Micromedex) - Includes Dosage Information
  • zileuton Concise Consumer Information (Cerner Multum)
  • Zyflo Prescribing Information (FDA)
  • Zyflo CR Prescribing Information (FDA)