Zileuton (patient information)

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Why is this medication prescribed

Zileuton is used to prevent asthma symptoms. It works by blocking the formation of substances that cause inflammation, fluid retention, mucous secretion, and constriction in your lungs.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used

Zileuton comes as a tablet to take by mouth. It usually is taken four times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take zileuton exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Zileuton controls asthma symptoms but does not cure them. Continue to take zileuton even if you feel well. Do not stop taking zileuton without talking to your doctor.

What special precautions should I follow

Before taking zileuton

  • tell your doctor and pharmacist if you are allergic to zileuton or any other drugs.
  • tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially anticoagulants ('blood thinners') such as warfarin (Coumadin), propranolol (Inderal), terfenadine (Seldane), theophylline (Theo-Dur), and vitamins.
  • tell your doctor if you have or have ever had liver disease or if you consume alcohol regularly.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking zileuton, call your doctor.

What special dietary instructions should I follow

Ask your doctor for advice on how much alcohol is safe to drink while you are taking this medicine.

What should I do if I forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side Effects

Mild side effects

Zileuton may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away.

  • headache
  • upset stomach
  • heartburn
  • vomiting
  • constipation
  • nervousness
  • dizziness
  • insomnia
  • gas

Severe side effects

If you experience any of the following symptoms, call your doctor immediately.

  • stomach pain
  • fatigue
  • itching
  • yellowing of the skin or eyes
  • flu-like symptoms

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to monitor your liver function while you are taking zileuton.

Call your doctor if your asthma symptoms do not improve or worsen.

Zileuton will not stop an acute attack that has already started. Continue to use the medication prescribed for your acute attacks.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

  • Zyflo®
  • Filmtab®

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