Important Safety Information about XIFAXAN 200 mg
XIFAXAN® (rifaximin) 200 mg 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 E coli. XIFAXAN should be discontinued if diarrhea symptoms get worse or persist more than 24 to 48 hours and alternative antibiotic therapy should be considered. E 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%).
Please see complete Prescribing Information for XIFAXAN 200 mg.
*In a randomized, double-blind, placebo-controlled study conducted in Mexico, Guatemala, and Kenya, the efficacy of XIFAXAN 200 mg (orally 3 times a day for 3 days) was evaluated in 254 adult subjects with travelers' diarrhea. Stool specimens were collected before treatment and 1 to 3 days following the end of treatment to identify enteric pathogens, predominantly E coli. The clinical efficacy of XIFAXAN 200 mg was assessed by the time to return to normal, formed stools and resolution of symptoms.
References: 1. Yates J. Traveler’s diarrhea. Am Fam Physician. 2005;71:2095-2100. 2. XIFAXAN [prescribing information]. Raleigh, NC: Salix Pharmaceuticals, Inc; 2011.
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