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Zileuton extended-release tablets

Generic Name: zileuton (zye-LOO-ton)
Brand Name: Zyflo CR

Zileuton extended-release tablets 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 extended-release tablets 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 extended-release tablets if:

  • you are allergic to any ingredient in zileuton extended-release tablets
  • you have liver disease or abnormal liver function tests
  • you are taking astemizole, pimozide, or terfenadine

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

Slideshow: Asthma: 10 Things You Need To Do To Keep It In Check

Before using zileuton extended-release tablets:

Some medical conditions may interact with zileuton extended-release tablets. 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
  • if you have trouble swallowing tablets

Some MEDICINES MAY INTERACT with zileuton extended-release tablets. 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 extended-release tablets's side effects
  • Astemizole, beta-blockers (eg, propranolol), calcium channel blockers (eg, amlodipine), cisapride, cyclosporine, pimozide, terfenadine, or theophylline because the risk of their side effects may be increased by zileuton extended-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if zileuton extended-release tablets 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 extended-release tablets:

Use zileuton extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with zileuton extended-release tablets. Talk to your pharmacist if you have questions about this information.
  • Take zileuton extended-release tablets by mouth within 1 hour after the morning and evening meals, unless your doctor tells you otherwise.
  • Swallow zileuton extended-release tablets whole. Do not break, crush, or chew before swallowing.
  • Take zileuton extended-release tablets on a regular schedule to get the most benefit from it. Taking zileuton extended-release tablets at the same times each day will help you remember to take it.
  • Continue to take zileuton extended-release tablets even if you feel well. Do not miss any doses.
  • If you miss a dose of zileuton extended-release tablets, 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 extended-release tablets.

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 extended-release tablets. Do not stop using zileuton extended-release tablets without checking with your doctor.
  • Zileuton extended-release tablets 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 extended-release tablets (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.
  • Some patients taking zileuton extended-release tablets have developed mental or mood changes, including sleep problems and behavior changes. Contact your doctor immediately if you experience any unusual symptoms while taking zileuton extended-release tablets.
  • Lab tests, including liver function, may be performed while you use zileuton extended-release tablets. 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 extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially liver problems.
  • Zileuton extended-release tablets should not be used 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 extended-release tablets while you are pregnant. It is not known if zileuton extended-release tablets is found in breast milk. Do not breast-feed while taking zileuton extended-release tablets.

Possible side effects of zileuton extended-release tablets:

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:

Diarrhea; headache; muscle aches; nausea; nose irritation; sinus pain; symptoms of upper respiratory tract infection (eg, cough, mild sore throat, runny or stuffy nose, sneezing); throat pain or irritation.

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; fever, chills, or persistent sore throat; mental or mood changes; sleep problems; symptoms of liver problems (eg, dark urine; flu-like symptoms; pale stools; persistent loss of appetite; right upper stomach pain; unusual nausea, sluggishness, or tiredness; yellowing of the skin or eyes); unusual changes in behavior.

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.

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 zileuton extended-release tablets:

Store at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep zileuton extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about zileuton extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Zileuton extended-release tablets 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 zileuton extended-release tablets 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 zileuton extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to zileuton extended-release tablets. 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 zileuton extended-release tablets.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
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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