The Prescribing Program for LOTRONEX (PPL) connects you with support, education and access to information about the safety of Alosetron hydrochloride. The Prescribing Program for LOTRONEX facilitates healthcare provider and patient education on the safety of Alosetron hydrochloride. Healthcare providers who are appropriately licensed to prescribe may enroll in the Prescribing Program for LOTRONEX. Only those enrolled can prescribe LOTRONEX® (Alosetron hydrochloride) tablets or ALOSETRON hydrochloride tablets distributed by Actavis, Inc.
INDICATION: 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 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 Alosetron hydrochloride in men.
Please consult the Complete Prescribing Information.