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Title: FDA Clears New Dose For Arthritis Drug Lodine
URL: http://www.pslgroup.com/dg/58112.htm
Doctor's Guide
February 4, 1998


PHILADELPHIA, PA -- February 4, 1998 -- The United States Food and Drug Administration has granted marketing clearance to a new 500 mg dosage strength of Wyeth-Ayerst Laboratories's Lodine(R) XL, a once-daily version of the popular arthritis medication Lodine(R).

A member of the nonsteroidal anti-inflammatory class of drugs (NSAIDs), Lodine XL (etodolac extended-release tablets) now is available in 400 mg, 500 mg and 600 mg tablets. The Lodine XL 500 mg tablet enables physicians to prescribe the maximum dosage of Lodine XL -- 1,000 mg per day -- as two tablets in a single daily dose.

Lodine XL (etodolac extended-release tablets) provides arthritis patients not only with affordable and effective pain relief, but also with an easy-to-follow and easy-to-remember treatment schedule that may help them better manage their condition.

NSAIDs represent a broad category of drugs that includes more than 20 different branded compounds on the market. They often are considered first-line therapy for arthritis, a condition that affects one in seven Americans. As with all NSAIDs, the most common complaints associated with Lodine XL use relate to the gastrointestinal tract. Serious GI toxicity such as perforation, ulceration, and bleeding can occur in patients treated chronically with NSAID therapy. Serious renal and hepatic reactions have been reported rarely. Lodine XL should not be given to patients who have previously shown hypersensitivity to it or in whom aspirin or other NSAIDs induce asthma, rhinitis, urticaria, or other allergic reactions. Fatal asthmatic reactions have been reported in such patients receiving NSAIDs.

Clinical trials have established that Lodine XL is effective in managing the pain and inflammation associated with osteoarthritis and rheumatoid arthritis. In one study of Lodine XL used for the treatment of rheumatoid arthritis (RA), 500 mg of Lodine XL taken as two tablets once daily was found to be effective in relieving the symptoms of RA, especially morning stiffness -- which is significant because it indicates that Lodine XL 500 mg was working to relieve inflammation throughout the night. This is an important benefit of Lodine XL -- it can relieve arthritis symptoms around the clock.

More information on: Lodine, Wyeth-Ayerst

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