Zyflo

DRUG DESCRIPTION

Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the formation of leukotrienes from arachidonic acid. Zileuton has the chemical name ()-1-(1-Benzo[b]thien-2-ylethyl)-1-hydroxyurea and the following chemical structure:

ZYFLO (zileuton) Structural Formula Illustration

Zileuton

Zileuton has the molecular formula C11H12N2O2S and a molecular weight of 236.29. It is a racemic mixture (50:50) of R(+) and S(-) enantiomers. Zileuton is a practically odorless, white, crystalline powder that is soluble in methanol and ethanol, slightly soluble in acetonitrile, and practically insoluble in water and hexane. The melting point ranges from 144.2#C to 145.2#C. ZYFLO (zileutin) tablets for oral administration are supplied in one dosage strength containing 600 mg of zileuton.

Inactive Ingredients: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, sodium starch glycolate, talc, and titanium dioxide.

What are the precautions when taking zileutin (Zyflo)?

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 certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: active liver disease.

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...

Read All Potential Precautions of Zyflo


Zyflo Consumer (continued)

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: active liver disease.

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.



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