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Study raises concerns about tablet splitting

(May 18, 2004) -- Back and neck pain sufferers who divide the most frequently prescribed muscle relaxant may be getting anywhere from half to one-and-a-half times the amount of medicine they believe they are taking, suggests a new study examining the practice of tablet splitting. This may place them at an increased risk of encountering side effects such as drowsiness and fatigue from too much medication, according to the study's primary investigator.

Researchers at the Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey, recently conducted a study to determine the level of weight variability of tablet fragments when the muscle relaxant cyclobenzaprine HCl 10 mg was split into halves with two commonly used devices -- a tablet splitter and a kitchen knife. Initiation of the study followed anecdotal reports that patients given a prescription for branded FLEXERIL (cyclobenzaprine HCl) 5 mg tablets were being advised to split generic cyclobenzaprine HCl 10 mg tablets instead of taking the 5 mg tablet as prescribed by their physician. FLEXERIL 5 mg, approved by the U.S. Food & Drug Administration in February 2003, is comparable in efficacy to the 10 mg strength, but has been shown to be less sedating.

"Ideally, an evenly split 10 mg tablet should have 100 percent of the half tablet weight and 5 mg of the medication," explained study investigator Thomas J. Cook, Ph.D., Assistant Professor, Department of Pharmaceutics. "In this study, the variance in estimated drug content due to uneven tablet splitting ranged anywhere from 50 to 150 percent of the ideal targets, meaning a patient would have no guarantee of receiving a full half-dose consistently throughout the course of therapy." According to its labeling, FLEXERIL 5 mg is recommended as a 2-3 week adjunct to rest and physical therapy for the relief of muscle spasm associated with acute, painful musculoskeletal conditions.

Since generic cyclobenzaprine HCl 10 mg tablets
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Contact: Cattaliya Snider
sniderc@ruderfinn.com
310-479-9929
McNeil Consumer & Specialty Pharmaceuticals
18-May-2004


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