Zileuton

Generic name: Zileuton
Drug class: Leukotriene modifiers

Usage of Zileuton

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 side effects

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.

Before taking Zileuton

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.

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How to use Zileuton

Usual Adult Dose for Asthma -- Maintenance:

Immediate Release:-600 mg orally four times a day-Maximum daily dose: 2400 mgExtended Release:-1200 mg orally twice a day, within one hour after morning and evening meals-Maximum daily dose: 2400 mgComments:-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 mgComments:-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

Warnings

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.

What other drugs will affect Zileuton

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.

Disclaimer

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