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XIFAXAN

Future Indications

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Future Indications

This information is intended for U.S. Healthcare Professionals only.

XIFAXAN® has been marketed in Italy (Normix® and Rifacol®) since 1988 and is now approved in 27 countries with over 500 million tablets prescribed. Over 440 clinical papers, abstracts and textbook chapters discussing the use of XIFAXAN for treatment of a broad range of GI disorders have been published to date. These GI disorders include travelers’ diarrhea, infectious diarrhea, hepatic encephalopathy, Crohn's disease, ulcerative colitis, irritable bowel syndrome, pouchitis, small-bowel bacterial overgrowth, H pylori/peptic ulcer disease, prophylaxis for GI surgery, and diverticular disease. Studies to assess the utility of XIFAXAN for the treatment of hepatic encephalopathy, Crohn's disease, small bowel overgrowth/irritable bowel syndrome, Clostridium difficile infection (CDI), prevention of Shigella induced diarrhea and the prevention of travelers’ diarrhea have been completed, planned or ongoing.



SAFETY CONSIDERATIONS

Xifaxan® (rifaximin) Tablets are indicated for the treatment of patients (≥12 years of age) with travelers’ diarrhea caused by noninvasive strains of Escherichia coli. Xifaxan should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli. Xifaxan should be discontinued if diarrhea symptoms get worse or persist more than 24-48 hours and alternative antibiotic therapy should be considered. Escherichia coli has been shown to develop resistance to rifaximin in vitro. However, the clinical significance of such an effect has not been studied.

In clinical trials, Xifaxan was generally well tolerated. The most common side effects (vs. placebo) were flatulence 11.3% (vs. 19.7%), headache 9.7% (vs. 9.2%), abdominal pain 7.2% (vs. 10.1%), rectal tenesmus 7.2% (vs. 8.8%), defecation urgency 5.9% (vs. 9.2%) and nausea 5.3% (vs. 8.3%).

For complete Prescribing Information, please click here.


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