INDICATION: LOTRONEX/alosetron hydrochloride is indicated only for women with severe diarrhea-predominant irritable bowel syndrome who have: chronic irritable bowel syndrome symptoms (generally lasting 6 months or longer), had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and not responded adequately to conventional therapy. Diarrhea-predominant irritable bowel syndrome is severe if it includes diarrhea and one or more of the following: frequent and severe abdominal pain/discomfort, frequent bowel urgency or fecal incontinence, disability or restriction of daily activities due to irritable bowel syndrome. Because of infrequent but serious gastrointestinal adverse events associated with LOTRONEX/alosetron hydrochloride, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. Clinical studies have not been performed to adequately confirm the benefits of LOTRONEX/alosetron hydrochloride in men.

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