Zileuton Extended-Release TabletsGeneric Name:
Zileuton (zye-LOO-ton)Brand Name:
Zileuton Extended-Release Tablets are used for:
Preventing and treating asthma in patients 12 years old and older. It may also be used for other conditions as determined by your doctor.
Zileuton Extended-Release Tablets are a leukotriene synthesis inhibitor. It works by blocking the formation of a substance called leukotriene, which helps to decrease certain asthma and allergy symptoms.
Do NOT use Zileuton Extended-Release Tablets if:
- you are allergic to any ingredient in Zileuton Extended-Release Tablets
- you have liver disease or abnormal liver function tests
- if you are taking an H1 antagonist (eg, astemizole, terfenadine) or pimozide
Contact your doctor or health care provider right away if any of these apply to you.
Before using Zileuton Extended-Release Tablets:
Some medical conditions may interact with Zileuton Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of liver problems (eg, hepatitis) or symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine)
- if you have a history of mental or mood problems (eg, depression) or suicidal thoughts or actions
- if you drink alcohol
- if you have trouble swallowing tablets
Some MEDICINES MAY INTERACT with Zileuton Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
- Azole antifungals (eg, ketoconazole) because they may increase the risk of Zileuton Extended-Release Tablets's side effects
- Beta-blockers (eg, propranolol), calcium channel blockers (eg, amlodipine), cisapride, cyclosporine, H1 antagonists (eg, astemizole, terfenadine), pimozide, or theophylline because the risk of their side effects may be increased by Zileuton Extended-Release Tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if Zileuton Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Zileuton Extended-Release Tablets:
Use Zileuton Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Zileuton Extended-Release Tablets. Talk to your pharmacist if you have questions about this information.
- Take Zileuton Extended-Release Tablets by mouth within 1 hour after the morning and evening meal.
- Swallow Zileuton Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
- Take Zileuton Extended-Release Tablets on a regular schedule to get the most benefit from it. Taking Zileuton Extended-Release Tablets at the same times each day will help you remember to take it.
- Continue to take Zileuton Extended-Release Tablets even if you feel well. Do not miss any doses.
- If you miss a dose of Zileuton Extended-Release Tablets, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Zileuton Extended-Release Tablets.
Important safety information:
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- It may take a few weeks before you get the full benefit of Zileuton Extended-Release Tablets. Do not stop using Zileuton Extended-Release Tablets without checking with your doctor.
- Zileuton Extended-Release Tablets will not stop an asthma attack once it has already started. Be sure to carry a short-acting bronchodilator with you at all times to treat any breathing problems that may occur between doses of Zileuton Extended-Release Tablets (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop asthma attacks, check with your doctor or pharmacist.
- Tell your doctor at once if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it more often, or if you have a decrease in your peak flow meter results.
- Contact your doctor or seek medical care right away if you have breathing problems that worsen quickly, or if you use your short-acting bronchodilator and do not get relief.
- Talk with your doctor or pharmacist about all your asthma medicines and how to use them. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.
- Contact your doctor at once if you develop upper stomach pain, severe or persistent nausea, unusual tiredness or fatigue, yellowing of the eyes or skin, dark urine, pale stools, fever, or flu-like symptoms. These may be signs of liver problems.
- Some patients taking Zileuton Extended-Release Tablets have developed mental or mood changes, including suicidal thoughts or actions. Contact your doctor immediately if you experience symptoms such as agitation, aggression, hostility, anxiety, depression, strange dreams, trouble sleeping, sleepwalking, tremor, hallucinations, restlessness, irritability, or any unusual change in mood or behavior. Contact your doctor immediately if any signs of suicidal thoughts or actions occur.
- Lab tests, including liver function, may be performed while you use Zileuton Extended-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Zileuton Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially liver toxicity.
- Zileuton Extended-Release Tablets should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zileuton Extended-Release Tablets while you are pregnant. It is not known if Zileuton Extended-Release Tablets are found in breast milk. Do not breast-feed while taking Zileuton Extended-Release Tablets.
Possible side effects of Zileuton Extended-Release Tablets:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; headache; muscle aches; nausea; nose irritation; sinus inflammation; throat pain or irritation.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; fever, chills, or persistent sore throat; flu-like symptoms; mental or mood changes (eg, agitation, aggression, hostility, anxiety, depression, strange dreams, sleepwalking, tremor, hallucinations, restlessness, irritability); pale stools; right upper stomach pain; severe or persistent nausea or stomach pain; suicidal thoughts or actions; trouble sleeping; unusual changes in behavior; unusual tiredness or weakness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.Proper storage of Zileuton Extended-Release Tablets:
Store at controlled room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zileuton Extended-Release Tablets out of the reach of children and away from pets.
- If you have any questions about Zileuton Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
- Zileuton Extended-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Zileuton Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
- Zileuton Professional Patient Advice (Wolters Kluwer)
- Zileuton Detailed Consumer Information (PDR)
- zileuton Advanced Consumer (Micromedex) - Includes Dosage Information
- zileuton Concise Consumer Information (Cerner Multum)
- Zyflo Prescribing Information (FDA)
- Zyflo CR Prescribing Information (FDA)