Zileuton Extended-Release Tablets

What is this medication?

ZILEUTON (zye LOO ton) prevents and treats the symptoms of asthma. It works by decreasing inflammation of the airways, making it easier to breathe. Do not use it to treat a sudden asthma attack.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Zyflo CR

What should I tell my care team before I take this medication?

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

• If you often drink alcohol
• Liver disease
• An unusual or allergic reaction to zileuton, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on your prescription label. Take your doses at regular intervals. Take this medication with food. Do not cut, crush or chew this medication. Swallow the tablets whole. Do not take your medication more often than directed. Do not stop taking except on your care team's advice.

Talk to your care team about the use of this medication in children. While this medication has been used in children as young as 12 years of age, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

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 may interact with this medication?

This medication may interact with the following:

• Caffeine
• Propranolol
• Terfenadine
• Theophylline or aminophylline
• Tizanidine
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your asthma symptoms do not improve. Take your medication even when you do not have symptoms. Do not stop taking any of your medication(s) unless your care team tells you to.

If you have asthma, talk to your care team about what to do in an acute asthma attack. Always have your inhaled rescue medication for asthma attacks with you.

You may need blood work done while taking this medication.

Patients and their families should watch for new or worsening thoughts of suicide or depression. Also watch for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. Any worsening of mood or thoughts of suicide or dying should be reported to your care team right away.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression

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

• Headache
• Muscle pain
• Nausea
• Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

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

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.