IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ZILEUTON EXTENDED-RELEASE - ORAL

(zye-LOO-ton)

COMMON BRAND NAME(S): Zyflo CR

USES: This medication is used to prevent asthma symptoms and to decrease the number of asthma attacks. Controlling your asthma can improve your ability to exercise, decrease time lost from work or school, and decrease the number of times you need to use your quick-relief inhaler (e.g., albuterol, salbutamol). This drug works by decreasing the amount of certain natural substances (leukotrienes) made by the body. Leukotrienes may cause or worsen asthma.

This medication does not work immediately and should not be used to treat sudden asthma attacks.

The manufacturer does not recommend the use of zileuton for children under 12 years old due to the risk of liver problems.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using zileuton and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with food, usually 2 times daily (within 1 hour after the morning and evening meal) or as directed by your doctor. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

Use this medication regularly to get the most benefit from it, even during sudden asthma attacks or periods when you have no asthma symptoms. To help you remember, use it at the same times each day. Do not increase or decrease your dose or stop using this medication without consulting your doctor. Continue to use other medications for asthma as directed by your doctor.

Seek immediate medical attention if your asthma symptoms worsen, if you notice that you are using more of your quick-relief inhaler (e.g., albuterol, salbutamol), or if you need to use the quick-relief inhaler more than the maximum number of times prescribed in 24 hours.