Zileuton is used to prevent asthma attacks and for long-term management of asthma in adults and children at least 12 years old.

Zileuton may also be used for purposes not listed in this medication guide.

Zileuton is not a fast-acting rescue medicine for asthma attacks. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working.

Call your doctor right away if you have any changes in behavior or sleep problems.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Zileuton tablets are usually taken 4 times a day at the same times each day, with or without food. If you cannot swallow a tablet whole, split it in half and take one half at a time.

Zileuton extended-release tablets are usually taken twice daily, within 1 hour after your morning and evening meals.

Swallow the extended-release tablet whole and do not crush, chew, or break it.

Your symptoms may not improve for several days or a few weeks. Keep using zileuton even after you have no symptoms (a sign that the medicine is working).

Zileuton is not a fast-acting rescue medicine for asthma attacks. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working.

Do not change your dose or stop using asthma medication without your doctor's advice.

You will need frequent blood tests to check your liver function.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Asthma -- Maintenance:

Immediate Release:
-600 mg orally four times a day
-Maximum daily dose: 2400 mg

Extended Release:
-1200 mg orally twice a day, within one hour after morning and evening meals
-Maximum daily dose: 2400 mg

Comments:
-Immediate release tablets may be taken with meals and at bedtime.
-Assess hepatic function enzymes prior to initiating this drug and periodically during treatment.

Use: Prophylaxis and chronic treatment of asthma

Usual Pediatric Dose for Asthma -- Maintenance:

Less than 12 years: Not recommended.

12 years or older:
-Immediate Release: 600 mg orally four times a day
-Extended Release: 1200 mg orally twice a day, within one hour after morning and evening meals
-Maximum daily dose: 2400 mg

Comments:
-Immediate release tablets may be taken with meals and at bedtime.
-Assess hepatic function enzymes prior to initiating this drug and periodically during treatment.

Use: Prophylaxis and chronic treatment of asthma

You should not use zileuton if you are allergic to it, or if you have:

• liver disease; or

• very high liver enzymes on a blood test.

Tell your doctor if you have ever had:

• liver problems, dark urine, or jaundice (yellow eyes or skin); or

• if you drink large amounts of alcohol.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of zileuton on the baby.

Skip the missed dose and take your next dose at the regular time. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

Avoid drinking alcohol. It may increase your risk of liver damage.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Zileuton may cause serious side effects. Call your doctor at once if you have:

• worsening asthma symptoms;

• sleep problems;

• changes in behavior or sleep problems; or

• liver problems--nausea, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of zileuton may include:

• upset stomach, diarrhea, nausea, or stomach pain;

• muscle aches;

• headache; or

• runny or stuffy nose, sinus pain, sneezing, sore throat.

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.

When you start or stop taking zileuton, your doctor may need to adjust the doses of other medicines you use on a regular basis, especially:

• propranolol;

• theophylline; or

• warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may affect zileuton, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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.