ZYFLO® (zileuton tablets)
ZYFLO® (zileuton tablets) and ZYFLO CR™ (zileuton) extended-release tablets are the only FDA-approved leukotriene synthesis inhibitors for the treatment of asthma. ZYFLO is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. The recommended dose is one 600 mg tablet four times a day. ZYFLO is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Therapy with ZYFLO can be continued during acute exacerbations of asthma.
Zileuton inhibits the production of 5-lipoxygenase (5-LO), the main enzyme responsible for the production of leukotrienes, a family of inflammatory mediators that can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion. ZYFLO and ZYFLO CR have a unique mechanism of action that works early in the inflammatory cascade, thus blocking all types of leukotrienes.
ZYFLO was first approved to treat asthma in the United States in 1996. Critical Therapeutics acquired worldwide rights to the drug and other formulations of zileuton in late 2003 and early 2004. In connection with the technology transfer and manufacturing of ZYFLO, Critical Therapeutics submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) on March 31, 2005 for approval of a new manufacturing process and new production sites. On September 28, 2005, the FDA approved the Company’s sNDA to manufacture and market ZYFLO. Critical Therapeutics markets ZYFLO in the U.S. with its co-promotion partner, Dey, L.P.
All medicines, including ZYFLO, cause side effects in some people. Some of the most common side effects associated with the use of ZYFLO are abdominal pain, upset stomach and nausea. A small percentage of patients treated with ZYFLO show an increased release of a liver enzyme known as ALT. As a result, the level of liver enzymes in patients treated with ZYFLO should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO and repeat the test on a regular basis while patients are on the medication.
Please see full prescribing information for ZYFLO® (zileuton tablets).
Please visit www.zyflo.com for additional information about ZYFLO.
Please see full prescribing information for ZYFLO CR™ (zileuton) extended-release tablets.
Please visit www.zyflocr.com for additional information about ZYFLO CR. |
