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. Do not use in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli.

Important Safety Information about XIFAXAN 200 mg

XIFAXAN® (rifaximin) 200 mgXIFAXAN® (rifaximin) 200 mg tablets are contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.

XIFAXAN was not effective in diarrhea complicated by fever and/or blood in the stool or diarrhea due to pathogens other than E. coli. If diarrhea symptoms get worse or persist for more than 24-48 hours, discontinue XIFAXAN and consider alternative antibiotics.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C. difficile. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.

Prescribing XIFAXAN for travelers' diarrhea in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

There is increased systemic exposure in patients with more severe hepatic dysfunction. Therefore, caution should be exercised when administering XIFAXAN to patients with severe hepatic impairment (Child-Pugh C).

Based on animal data, XIFAXAN may cause fetal harm. Discontinue in nursing mothers after taking into account the importance of the drug to the mother.

Most common adverse reactions in travelers' diarrhea occurring in ≥ 5% of patients in clinical studies were flatulence, headache, abdominal pain, rectal tenesmus, defecation urgency 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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