cornerstone

  • ZYFLO CR® achieved a 21% improvement in FEV1 at 12 weeks (P=0.03)
    • ZYFLO CR® achieved a 13% improvement in FEV1 at the first study time point of 2 weeks  (P<0.01)
  • ZYFLO CR® achieved a 44% increase in FEV1 volume at 12 weeks (P=0.02)

ZYFLO CR® significantly reduced use of SABA rescue therapy (n=199; P=0.009)2



ZYFLO CR® is contraindicated in patients with active liver disease or transaminase elevations 3 times the upper limit of normal.

Please see Important Safety Information and full Prescribing Information.




Important Safety Information


ZYFLO CR® is a leukotriene synthesis inhibitor indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Do not use ZYFLO CR® to treat an acute asthma attack.

ZYFLO CR® is contraindicated for patients with active liver disease or persistent hepatic function enzyme elevations 3 times the upper limit of normal. Assessment of hepatic function enzymes prior to and during ZYFLO CR® therapy should be undertaken. ZYFLO CR® is also contraindicated for patients with a history of allergic reactions to zileuton or any of the other ingredients.

The active ingredient in ZYFLO CR® increases theophylline, warfarin, and propranolol levels. Dose adjustment of these other drugs and patient monitoring may be required. ZYFLO CR® should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease. Neuropsychiatric events, including sleeping disorders and behavioral changes, may occur with ZYFLO CR®.

The most common adverse reactions (>5%) include: sinusitis, nausea, and pharyngolaryngeal pain.