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Treating Patients with ZYFLO CR® (zileuton)

ZYFLO CR® is not appropriate for all asthma patients¹

  • ZYFLO CR® is contraindicated in patients with active liver disease or persistent hepatic function enzyme elevations ≥3X the upper limit of normal. ZYFLO CR® is also contraindicated for patients with a history of allergic reactions to zileuton or any of the other ingredients
  • ALT elevations were observed in 1.8% of patients treated with ZYFLO CR® vs 0.7% treated with placebo in a 6-month study
  • 82% of elevations were reported during the first 3 months of treatment
  • Most elevations resolved within 21 days after discontinuation
  • No jaundice, chronic liver disease, or deaths occurred in clinical trials with ZYFLO CR®
  • If clinical signs and/or symptoms of liver dysfunction develop (eg, right upper quadrant pain, nausea, fatigue, lethargy, pruritus, jaundice, or "flu-like" symptoms) or transaminase elevations ≥5 times the upper limit of normal occur, discontinue ZYFLO CR® and follow hepatic function enzymes until normal.
  • Use with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.

Please see Important Safety Information and Full Prescribing Information.

*See ZYFLO connect® Terms and Conditions

Reference: 1. ZYFLO CR® (zileuton) prescribing information, Chiesi USA, Inc., March 2014.