Generic Name: zileuton (zye LOO ton)Brand names: Zyflo CR, Zyflo
Zileuton is a leukotriene (loo-koe-TRY-een) inhibitor. Leukotrienes are chemicals your body releases when you breathe in an allergen (such as pollen). These chemicals cause swelling in your lungs and tightening of the muscles around your airways, which can result in asthma symptoms.
Zileuton is used to prevent asthma attacks in adults and children as young as 12 years old.
Zileuton may also be used for other purposes not listed in this medication guide.
Call your doctor right away if you feel that this medicine is not working as well as usual, or if it makes your condition worse. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.Avoid drinking alcohol while you are taking zileuton. Alcohol can increase your risk of liver damage. Call your doctor at once if you have any mood or behavior changes, anxiety, depression, or thoughts about suicide or hurting yourself.
If you drink large amounts of alcohol or have a history of liver disease, you may need a dose adjustment or special tests to safely take zileutonFDA pregnancy category C. It is not known whether zileuton is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether zileuton passes into breast milk or if it could harm a nursing baby. . Do not take zileuton without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child without a doctor's advice.
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.Take zileuton with a full glass of water. Zileuton tablets and extended-release tablets contain the same amount of the drug, but they are not taken in the same way. Follow your doctor's instructions.
Zileuton tablets are usually taken 4 times daily, with meals and at bedtime. Zileuton tablets may be swallowed whole or split in half to make swallowing easier.
Zileuton extended-release tablets are usually taken twice daily, within 1 hour after your morning and evening meals.Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time. Do not use zileuton to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medication to treat an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks. It may take up to a few weeks of using this medicine before your symptoms improve. For best results, keep using zileuton as directed, even if you feel fine. Having no asthma symptoms is a sign that the medication is working.
Asthma is often treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor, even if you have no asthma symptoms.
Call your doctor right away if you feel that this medicine is not working as well as usual, or if it makes your condition worse. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.
To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled visits to your doctor.Store zileuton at room temperature away from moisture and heat.
See also: Zileuton dosage in more detail
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Symptoms of a zileuton overdose are not known.
Avoid situations or activities that may trigger an asthma attack.Avoid drinking alcohol while taking zileuton. Alcohol may increase your risk of liver damage.
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
mood or behavior changes, anxiety, depression, or thoughts about suicide or hurting yourself; or
worsening asthma symptoms.
Less serious side effects may include:
cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat;
diarrhea, upset stomach;
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Asthma -- Maintenance:
600 mg tablets:600 mg orally four times a day, with meals and at bedtime.600 mg extended release tablets2 tablets (1200 mg) orally twice daily, within 1 hour after morning or evening meals, for a total daily dose of 2400 mg.
Usual Pediatric Dose for Asthma -- Maintenance:
> 12 years:600 mg tablets:600 mg orally four times a day, with meals and at bedtime.600 mg extended release tablets2 tablets (1200 mg) orally twice daily, within 1 hour after morning or evening meals, for a total daily dose of 2400 mg.
Before taking zileuton, tell your doctor if you are taking any of the following drugs:
a blood thinner such as warfarin (Coumadin);
theophylline (Theo-Dur, Theolair, Elixophyllin, Slo-Phyllin, others); or
This list is not complete and there may be other drugs that can interact with zileuton. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.