Brand Zyflo CR

This medication is used to prevent asthma symptoms and to decrease the number of asthma attacks. Controlling your asthma can improve your ability to exercise, decrease time lost from work or school, and decrease the number of times you need to use your quick-relief inhaler (e.g., albuterol, salbutamol). This drug works by decreasing the amount of certain natural substances (leukotrienes) made by the body. Leukotrienes may cause or worsen asthma. This medication does not work immediately and should not be used to treat sudden asthma attacks. The manufacturer does not recommend the use of zileuton for children under 12 years old due to the risk of liver problems.

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 food, usually 2 times daily (within 1 hour after the morning and evening meal) or as directed by your doctor. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. Use this medication regularly to get the most benefit from it, even during sudden asthma attacks or periods when you have no asthma symptoms. To help you remember, use it at the same times each day. Do not increase or decrease your dose or stop using this medication without consulting your doctor. Continue to use other medications for asthma as directed by your doctor. 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.

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. This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: current liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, alcohol use. This medication may cause liver problems. Limit alcoholic beverages because alcohol may increase your risk for liver problems. Ask your doctor or pharmacist for more information. Older women may be more sensitive to the effects of the drug, especially liver problems. 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.

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.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: pimozide, propranolol, theophylline, tizanidine, warfarin. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Nausea, diarrhea or trouble sleeping may occur. If either 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 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, persistent nausea/vomiting. 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.

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.