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Zileuton extended-release tablets

What are Zileuton extended-release tablets?

ZILEUTON is used to treat asthma. It helps to decrease the symptoms of asthma. Do not use for an acute asthma attack.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • fever or infection

  • if you frequently drink alcohol containing drinks

  • liver disease

  • an unusual or allergic reaction to zileuton, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should this medicine be used?

Take this medicine by mouth with a glass of water. Follow the directions on your prescription label. Take it within one hour after morning and evening meals. Take your doses at regular intervals. Do not crush, chew, or cut the tablets. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this medicine has been used in children as young as 12 years of age, precautions do apply.

What if I miss a dose?

If you miss a dose, take your next dose at the scheduled time. Do not take double or extra doses.

What drug(s) may interact with Zileuton?

  • alosetron

  • astemizole

  • caffeine

  • cisapride

  • cyclosporine

  • pimozide

  • propranolol

  • tacrine

  • terfenadine

  • theophylline or aminophylline

  • warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Zileuton?

Visit your doctor or health care professional for regular checks on your progress. Because this drug may affect liver function, you will receive regular blood tests to check your liver enzymes.

It may take a few weeks to notice the full benefit of this medicine. Tell your doctor or health care professional if your asthma symptoms do not improve. Take this medicine even when you do not have any asthma symptoms. Feeling well is a sign the medicine is working to control your asthma. Do not stop taking your medicine unless your doctor tells you to.

Talk to your doctor about what to do if you have an acute asthma attack. This medicine does not treat an acute attack. Always have your inhaled rescue medicine for asthma attacks with you.

What side effects may I notice from receiving Zileuton?

Side effects that you should report to your prescriber or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • dark urine

  • difficulty breathing, wheezing

  • fever

  • flu-like symptoms (chills, fatigue, fever, muscle aches)

  • unusual weakness or tiredness

  • yellowing of the skin or eyes

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

  • abdominal pain

  • dizziness

  • headache

  • nausea

  • stomach upset

Where can I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Throw away any unused medicine after the expiration date.

Zileuton tablets

What are zileuton tablets?

Zileuton (Zyflo®) is used to treat asthma. It helps to reduce recurring symptoms of asthma, but it is not for rapid relief of asthma attacks. Generic zileuton tablets are not available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • liver disease

  • a history of alcoholism

  • fever or infection

  • an unusual or allergic reaction to zileuton, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I take this medicine?

Take zileuton tablets by mouth. Follow the directions on the prescription label. Take your doses at regular intervals. Zileuton may be taken with meals and at bedtime. Do not take your medicine more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with zileuton?

  • alosetron

  • astemizole

  • bosentan

  • caffeine

  • carbamazepine

  • certain drugs for anxiety, insomnia, or difficulty sleeping (such as alprazolam, diazepam, midazolam, or triazolam)

  • certain drugs used to lower cholesterol (atorvastatin, cerivastatin, lovastatin, simvastatin)

  • certain drugs used for HIV infection or AIDS (such as indinavir, ritonavir, or saquinavir)

  • certain heart or high blood pressure medicines (such as bepridil, diltiazem, felodipine, lidocaine, nicardipine, nifedipine, nimodipine, nisoldipine, propranolol, quinidine, or verapamil)

  • cisapride

  • clarithromycin or erythromycin

  • cyclosporine

  • donepezil

  • doxercalciferol

  • ergot alkaloids (such as dihydroergotamine, ergotamine, methysergide or methylergonovine)

  • guarana

  • imatinib, STI-571

  • paricalcitol

  • pimozide

  • ramelteon

  • sirolimus

  • steroid drugs (such as prednisone, hydrocortisone, dexamethasone)

  • tacrolimus

  • terfenadine

  • theophylline or aminophylline

  • voriconazole

  • warfarin

  • went yeast

  • zonisamide

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking zileuton?

It is important that you go on taking your medicine even when you do not have any asthma symptoms. Tell your prescriber or health care professional if your asthma symptoms do not start to improve after several days. Only stop taking zileuton on your prescriber's advice.

Visit your prescriber or health care professional for regular checks on your progress. Liver tests will need to be done on a regular basis while taking zileuton.

What side effects may I notice from taking zileuton?

Side effects that you should report to your prescriber or health care professional as soon as possible:

  • chest pain

  • difficulty breathing, wheezing

  • flu-like symptoms (chills, fatigue, fever, muscle aches)

  • nausea

  • pruritus

  • skin rash or itching

  • unusual weakness or tiredness

  • yellowing of the skin

Call your prescriber or health care professional immediately if you get any of these side effects.

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

  • back pain

  • dizziness

  • drowsiness

  • dyspepsia

  • headache

  • insomnia

  • numbness or tingling in the hands or feet

  • stomach pain

  • weakness

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

Publication Source: U.S. FDA-approved Package Insert
Date Last Modified: 6/6/2007