Zileuton tablets

What is this medication?

ZILEUTON (zye LOO ton) is used to treat asthma. It helps to decrease the symptoms of asthma. Do not use for an acute 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

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 medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on your prescription label. Take your doses at regular intervals. This medicine may be taken with meals and at bedtime. For ease of swallowing, the tablets may be taken whole or split in half. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this medicine 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?

• 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 doctor or health care professional for regular checks on your progress. Tell your doctor or health care professional if your asthma symptoms do not improve. Take your medicine even when you do not have symptoms. Do not stop taking any of your medicine(s) unless your doctor tells you to.

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

You may need blood work done while taking this medicine.

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 health care professional right away.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in behavior, emotions or moods
• fever
• hallucinations
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• trouble sleeping

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

• abdominal pain
• dizziness
• 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.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Throw away any unused medicine 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.