Zileuton

What is ZILEUTON?

(ZILEUTON) Zileuton is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. Controlling symptoms of asthma helps you maintain your normal activities and cuts down on time lost from work or school. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, salbutamol) as prescribed. This drug is not recommended for use in children younger than 12 years due to possible risk of liver problems.

How should I use ZILEUTON?

Read the Patient Information Leaflet if available from your pharmacist before you start taking zileuton and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with food as directed by your doctor, usually 2 times daily (within 1 hour after the morning and evening meal). Swallow the tablets whole. Do not crush, chew, or split the tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Keep taking this medication even if you feel well. Do not increase your dose, use this drug more often, or stop using it without first consulting your doctor. Get medical help right away if your asthma symptoms worsen or if you are using your quick-relief inhaler more than usual or more often than prescribed.

What should I tell my health care provider before I take ZILEUTON?

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. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older women may be at greater risk for liver problems while using this drug. 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 breastfeeding.

What may interact with ZILEUTON?

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. This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include fezolinetant, pimozide, among others.

What if I miss a dose of ZILEUTON?

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

What side effects may I notice from receiving ZILEUTON?

Nausea or diarrhea may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: symptoms of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), mental/mood changes (such as trouble sleeping, agitation, hallucinations, depression, thoughts of suicide). A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Where should I keep ZILEUTON?

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.