Indication for XIFAXAN 200 mg
The treatment of patients (≥ 12 years of age) with travelers' diarrhea (TD) caused by noninvasive strains of Escherichia coli.
Important Safety Information about XIFAXAN 200 mg
XIFAXAN® (rifaximin) 200 mg tablets are not for everyone. Do not take XIFAXAN if you have a known hypersensitivity to rifaximin or any of the ingredients in XIFAXAN.
If you have a fever and/or blood in your stool, XIFAXAN is not the right option for you. If your healthcare provider has told you that the cause of your diarrhea is something other than E. coli, XIFAXAN is not the right option for you. If your symptoms of diarrhea get worse or last more than 24-48 hours, you should call your healthcare provider.
XIFAXAN, like nearly all antibiotics, can alter the normal bacteria of the gut. This can lead to an overgrowth of Clostridium difficile (C. difficile) bacteria. If you take XIFAXAN, there is a chance you could experience diarrhea caused by C. difficile. C. difficile can cause symptoms ranging in severity from mild diarrhea to fatal colitis. If you suspect you have C. difficile–associated diarrhea, contact your healthcare provider immediately, as treatment may need to be discontinued.
There is an increased chance that XIFAXAN will spread through your body if your liver is not working well. Therefore, if you have severe hepatic impairment, which is a Child-Pugh score of C, you should talk to your healthcare provider before taking XIFAXAN.
Tell your doctor if you are taking drugs that are P-glycoprotein inhibitors (such as cyclosporine) as using these drugs with XIFAXAN may lead to increase in the amount of XIFAXAN absorbed by your body.
If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking XIFAXAN.
In the clinical study, the most common side effects—occurring in at least 5% of patients—were gas, headache, stomach pain, feeling of constantly needing to pass stools, feeling the need to pass stools urgently, and nausea.
Xifaxan is licensed by Alfa Wassermann, S.p.A. to Salix Pharmaceuticals, Inc.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch/ or call 1-800-FDA-1088.
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
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.