ZYFLO CR™ (zileuton) extended-release tablets
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ZYFLO CR™ (zileuton) extended-release tablets and ZYFLO® (zileuton tablets) are the only FDA-approved leukotriene synthesis inhibitors for the treatment of asthma. ZYFLO CR is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO CR is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO CR and ZYFLO can be continued during acute exacerbations of asthma. The recommended dose of ZYFLO CR is two 600 mg extended-release tablets twice daily, within one hour after morning and evening meals, for a total daily dose of 2400 mg.
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.
Critical Therapeutics submitted the New Drug Application (NDA) for ZYFLO CR to the FDA in July 2006. The NDA included results from two Phase III clinical trials that evaluated the safety and efficacy of zileuton CR in 818 asthma patients. The NDA also included results from three pharmacokinetic studies completed by Critical Therapeutics. Critical Therapeutics received approval from the FDA to market ZYFLO CR in the U.S. on May 30, 2007. Critical Therapeutics and its co-promotion partner, Dey, L.P. (DEY), a subsidiary of Mylan Inc., launched ZYFLO CR with a combined sales force of 240 representatives on September 27, 2007.
ZYFLO CR is contraindicated in patients with active liver disease or transaminase elevations greater than or equal to three times the upper limit of normal. A small percentage of patients treated with ZYFLO CR (2.5%) and ZYFLO (1.9%) in placebo-controlled trials showed an increased release of a liver enzyme known as ALT and bilirubin (an orange or yellowish pigment in bile). As a result, the level of liver enzymes in patients treated with ZYFLO CR should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO CR and repeat the test on a regular basis while patients are on the medication. Patients taking ZYFLO CR and theophylline should reduce the theophylline dose by 50%. Patients taking ZYFLO CR and propranolol or warfarin should be monitored and doses adjusted as appropriate. Most common side effects associated with the use of ZYFLO CR are sinusitis, nausea and pharyngolaryngeal pain.
Please see full prescribing information for ZYFLO CR™ (zileuton) extended-release tablets.
Please visit www.zyflocr.com for additional information about ZYFLO CR.
Please see full prescribing information for ZYFLO® (zileuton tablets).
Please visit www.zyflo.com for additional information about ZYFLO. |
