GENERIC NAME: ZILEUTON - ORAL (zye-LOO-ton)
BRAND NAME(S): Zyflo
USES: This medication is used to control long-term (chronic) asthma and help decrease the number of asthma attacks. Controlling asthma can decrease time lost from work or school. This drug improves asthma symptoms by blocking substances in the body called leukotrienes. It will not treat a sudden asthma attack.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 or without food, usually 4 times daily or as directed by your doctor.Continue taking this drug as directed, even during sudden asthma attacks. Do not stop taking this medication unless directed to do so by your doctor. Do not take more than the prescribed dose. Also, do not decrease the dose or stop taking any other asthma medication unless directed to do so by your doctor.Use this medication regularly to get the most benefit from it, even during asthma attacks and periods when you have no asthma symptoms. To help you remember, take it at the same times each day.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.
SIDE EFFECTS: Nausea, drowsiness, constipation, dizziness, trouble sleeping, gas, joint pain, eye redness, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: chest pain, neck pain/stiffness.Tell your doctor immediately if any of these rare but very serious side effects occur: mental/mood changes (e.g., agitation, aggression, hallucinations, abnormal dreams, depression, suicidal thoughts/suicide), yellowing skin/eyes, dark urine, severe stomach/abdominal pain, unusual tiredness, flu-like symptoms (e.g., headache, fever, chills, muscle aches).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking zileuton, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, alcohol use.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages because alcohol may add to this drug's drowsiness/dizziness effects and possible liver problems.Caution is advised when using this drug in elderly women because they may be more sensitive to the effects of the drug, especially liver toxicity.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: pimozide, propranolol, theophylline, warfarin.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (e.g., liver function, lung function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Avoid allergens, irritants, smoking, and other factors that make asthma worse.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.