Dey L.P. and Critical Therapeutics Launch Twice-Daily ZYFLO CR(TM) (Zileuton) Extended-Release Tablets for the Chronic Treatment...(thma attacks but can be continued during...)

Date:9/27/2007

thma attacks, but can be continued during acute exacerbations of asthma. Leukotrienes are inflammatory mediators in asthma that can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion. ZYFLO CR(TM) uses SkyePharma PLC's (LSE: SKP) proprietary Geomatrix(R) drug delivery technology, which controls the amount and rate of drug released into the body.

The recommended dose of ZYFLO CR(TM) 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. The recommended dose of ZYFLO(R) is one 600 mg immediate-release tablet four times a day for a total daily dose of 2400 mg.

ZYFLO CR(TM) and ZYFLO(R) are 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(TM) (2.5%) and ZYFLO(R) (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(TM) and ZYFLO(R) should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO CR(TM) and ZYFLO(R) and repeat the test on a regular basis while patients are on the medication. Patients taking ZYFLO CR(TM) and theophylline should reduce the theophylline dose by 50%. Patients taking ZYFLO CR(TM) and propranolol or warfarin should be monitored and doses adjusted as appropriate. Most common side effects associated with the use of ZYFLO CR(TM) and ZYFLO(R) are sinusitis, nausea and pharyngolaryngeal pain and abdominal pain, upset stomach and nausea, respectively.

For full prescribing information for ZYFLO CR(TM), please visit http://www.zyflocr.com or call the Company's toll free telephone number
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SOURCE Dey, L.P. Copyright©2007 PR Newswire. All rights reserved

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