ZYFLO CR® (zileuton) extended-release tablets

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Asthma is a disease of the airways that makes it difficult to move air in and out of the lungs. It affects millions of Americans. Its symptoms can range from mild to life-threatening, but with the right treatment and lifestyle changes, most cases of asthma can be controlled and serious consequences avoided.

ZYFLO CR is an extended-release oral medication used in the prevention and daily treatment of asthma in adults and children 12 years and older. ZYFLO CR is taken twice daily, and acts by blocking the formation of leukotrienes, chemicals which contribute to asthma symptoms.

Patient assistance:

  • If you have insurance coverage for ZYFLO CR, click here to print an instant rebate coupon. (Note: The instant rebate coupon is not valid for prescriptions covered by a federal or state health care program such as Medicare or Medicaid or for patients in the State of Massachusetts who have insurance coverage for ZYFLO CR.)
  • If you do not have insurance coverage for ZYFLO CR, please call Cornerstone Cares™ at 1-888-CRTX198 (1-888-278-9198) to learn if you qualify for patient assistance.

For ZYFLO CR full prescribing information, click here.

For ZYFLO® full prescribing information, click here.

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 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%) included: sinusitis, nausea and pharyngolaryngeal pain.

ZYFLO CR and ZYFLO are registered trademarks of Cornerstone Therapeutics Inc. Cornerstone Cares is a trademark of Cornerstone Therapeutics Inc.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


© 2014 Cornerstone Therapeutics Inc. All rights reserved. G-Q112-01 Rev 7
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