Zileuton: MedlinePlus Drug Information

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Other drug names:	A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Zileuton

(zye loo' ton)

Contents of this page:
Why is this medication prescribed? How should this medicine be used? Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow? What should I do if I forget a dose?	What side effects can this medication cause? What storage conditions are needed for this medicine? In case of emergency/overdose What other information should I know? Brand names

IMPORTANT WARNING: Return to top

[UPDATE 06/12/2009] FDA provided healthcare professionals with updated information on the original March 2008 early communication and January 2009 follow-up communication about the ongoing safety review for the leukotriene inhibitors, montelukast, zafirlukast and zileuton. Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling). The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. FDA recommends that:

Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.
Patients should talk with their healthcare providers if these events occur.
Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.

[UPDATE 01/13/2009] FDA provided updated information to its March 2008 Early Communication. FDA is continuing to review clinical trial data to assess other neuropsychiatric events, (mood and behavioral adverse events) related to drugs that act through the leukotriene pathway (montelukast [Singulair], zafirlukast [Accolate], zileuton [Zyflo]). As a result, FDA has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioral adverse events associated with montelukast, zafirlukast, and zileuton.

For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

Why is this medication prescribed? Return to top

Zileuton is used to prevent difficulty breathing, chest tightness, wheezing, and coughing due to asthma. Zileuton is not used to treat an asthma attack (sudden episode of shortness of breath, wheezing, and coughing) that has already started. Zileuton belongs to a class of medications called leukotriene synthesis inhibitors. It works by stopping the formation of certain natural substances that cause swelling, tightening, and mucus production in the airways.

How should this medicine be used? Return to top

Zileuton comes as an extended-release (long-acting) tablet to take by mouth. It is usually taken twice a day, within one hour after the morning and evening meals. 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.

Swallow the extended-release tablets whole. Do not split, chew, or crush them.

Do not use zileuton to treat a sudden asthma attack. Your doctor will prescribe a short-acting inhaler to use during attacks. Talk to your doctor about how to treat symptoms of a sudden asthma attack.

Continue to take all other medications that your doctor has prescribed to treat your asthma. Do not stop taking any of your medications or change the doses of any of your medications unless your doctor tells you that you should.

Tell your doctor if your asthma worsens during your treatment. Call your doctor if you need to use more of your fast-acting medication than usual or if you need to use the maximum number of doses of your fast-acting medication.

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

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Other uses for this medicine Return to top

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

What special precautions should I follow? Return to top

Before taking zileuton,

tell your doctor and pharmacist if you are allergic to zileuton or any other medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); beta blockers such as atenolol (Tenormin), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); clarithromycin (Biaxin); HIV protease inhibitors such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); nefazodone; telithromycin (Ketek); and theophylline (Theo-24, Uniphyl). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have liver disease. Your doctor will probably tell you not to take zileuton.
tell your doctor if you have difficulty swallowing pills, if you drink or have ever drunk large amounts of alcohol, and if you had liver disease in the past but recovered.
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.
ask your doctor about the safe use of alcohol while you are taking zileuton.

What special dietary instructions should I follow? Return to top

Unless your doctor tells you otherwise, continue your regular diet.

What should I do if I forget a dose? Return to top

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.

What side effects can this medication cause? Return to top

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

headache
heartburn
diarrhea
muscle pain
nose and throat irritation
pain or fullness in the face

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately.

rash
hives
pain in the upper right part of the stomach
nausea
vomiting
excessive tiredness
itching
yellowing of the skin or eyes
dark urine
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/Safety/MedWatch] or by phone [1-800-332-1088].

Zileuton may cause other side effects. Call your doctor if you experience any unusual problems while you are taking this medication.

What storage conditions are needed for this medicine? Return to top

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 Return to top

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? Return to top

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment.

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names Return to top

Zyflo CR®

Last Revised - 08/01/2009

American Society of Health-System Pharmacists, Inc. Disclaimer

AHFS^® Consumer Medication Information. © Copyright, 2009. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.