A nonsystemic antibiotic treatment option

A nonsystemic antibiotic treatment option

Xifaxan 200 mg – Travelers’ Diarrhea TreatmentXifaxan 200 mg – Travelers’ Diarrhea Treatment

XIFAXAN 200 mg is indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in patients 12 years of age and older.

XIFAXAN 200 mg, a minimally absorbed enteric antibiotic, targets pathogenic E coli.  XIFAXAN 200 mg is proven to treat travelers’ diarrhea, stopping symptoms in 79.2% of patients.1* The most common adverse reactions were flatulence, headache, abdominal pain, rectal tenesmus, defecation urgency and nausea.

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 mgXIFAXAN® (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
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

Please see complete Prescribing Information for XIFAXAN 200 mg.pdf

*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.  XIFAXAN [prescribing information]. Raleigh, NC: Salix Pharmaceuticals, Inc; 2011.

The information contained on this page is intended for US residents, healthcare providers, and pharmacists only.

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