Source: Kardiologiia  |  Posted 8 years ago

RESEARCH TRIANGLE PARK, NC -- March 10, 2004 -- Lotronex? (alosetron hydrochloride), which is approved for use in female patients with severe diarrhea-predominant irritable bowel syndrome (d-IBS) who meet the conditions stated in the labeling, is now available as 0.5mg tablets in addition to the currently marketed 1mg tablets.

Lotronex is to be used by women with severe diarrhea-predominant irritable bowel syndrome who have failed to respond to conventional therapy, whose IBS symptoms are chronic and who have had other gastrointestinal medical conditions that could explain their symptoms ruled out. Diarrhea-predominant IBS is severe if in addition to diarrhea the patient experiences at least one of the following symptoms: frequent and severe abdominal pain/discomfort; frequent bowel urgency/fecal incontinence; or disability/curtailment of daily activities because of IBS.

Serious gastrointestinal adverse events have been reported with the use of Lotronex. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalizations, blood transfusions, surgery and fatalities. Lotronex may be prescribed only by physicians who have enrolled in GlaxoSmithKline's Prescribing Program for Lotronex.

For safety reasons, the recommended starting dosage of Lotronex is 1 mg orally once a day for 4 weeks. If, after 4 weeks, the 1 mg once a day dosage is well tolerated but does not adequately control IBS symptoms, then the physician can increase the dosage to 1 mg twice a day, the dose used in controlled clinical trials. Although the efficacy of the 1 mg once a day dosage in treating d-IBS has not been evaluated in clinical trials, for safety reasons consideration should be given to continuing this dosage if it is well tolerated and IBS symptoms are controlled adequately. Lotronex should be discontinued in patients who have not had adequate control of IBS symptoms after 4 weeks of treatment with 1mg twice a day.

Although the recommended adult dosages have not changed, the new 0.5mg tablet can provide an option to physicians who need to customize dosing based on individualized patient needs.

Irritable bowel syndrome is a chronic, recurring condition that affects an estimated 18.5 million Americans, approximately 67% (12.4 M) of whom are women. Although the cause is currently unknown, IBS is characterized by multiple symptoms that include chronic or recurrent abdominal pain and discomfort together with irregular bowel function, such as diarrhea, constipation or alternating diarrhea and constipation. Approximately 30% of women with IBS have diarrhea-predominant IBS (3.7 million).

The Prescribing Program for Lotronex as well as educational materials is available by calling 1-888-825-5249 or by visiting this website, http://www.Lotronex.com.

SOURCE: GlaxoSmithKline