NONSYSTEMIC Xifaxan 550 rifaximin 550 mg tablets | Now approved for reduction in risk of overt hepatic encephalopathy recurrence Xifaxan 550 mg (rifaximin) head and bulb

Gut flora and overt HE

Gut flora is thought to play a role in overt HE

Gut flora may play an important role in HE in several ways:

Toxin Production
Gut flora produces the toxins that pass into the liver and cross into the blood-brain barrier, causing HE. These toxins include ammonia, manganese, and benzodiazepines.1,2
Overgrowth
Overgrowth of gut flora in the large intestine can result in bacterial translocation into the small intestine.3,4
In addition, overgrowth of gut flora can also slow intestinal motility.4,5
Inflammation
Imbalance of gut flora in the small and large intestines may contribute to the inflammatory component of cirrhosis, worsening the condition and leading to overt HE.4,6

Xifaxan 550 mg targets gut flora for effective overt HE management

Studies have shown Xifaxan is active against gut flora bacteria. In overt HE, Xifaxan is thought to have an effect on the gastrointestinal flora.7

To continue exploring gut flora and its role in overt HE, along with information about Xifaxan 550 mg for reduction in risk of overt HE recurrence, watch the video below.

Gut flora hepatic encephalopathy video

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Learn more about Xifaxan 550 mg.

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IMPORTANT SAFETY INFORMATION

XIFAXAN 550 mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥18 years of age. In the trials of XIFAXAN for HE, 91% of the patients were using lactulose concomitantly. XIFAXAN has not been studied in patients with MELD scores >25, and only 8.6% of patients in the controlled trial had MELD scores over 19. 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).

XIFAXAN is 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.

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.

The most common adverse reactions occurring in >8% of patients in the clinical study were edema peripheral (15%), nausea (14%), dizziness (13%), fatigue (12%), ascites (11%), muscle spasms (9%), pruritus (9%), and abdominal pain (9%).

Xifaxan550 is not available for sale outside the U.S.
Xifaxan550 is licensed by Alfa Wassermann S.p.A. to Salix Pharmaceuticals, Inc.

Complete Prescribing Information.PDF

You are encouraged to report negative side effects to the FDA. Visit www.fda.gov/safety/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
E-mail: Salix@medcomsol.com

References: 1. Dasarathy S, Mullen KD. Benzodiazepines in hepatic encephalopathy: sleeping with the enemy. Gut. 1998;42:764-765. 2. Butterworth, R. Hepatic encephalopathy—a serious complication of alcoholic liver disease. NIAAA Web site. http://pubs.niaaa.nih.gov/publications/arh27-2/143-145.htm. Accessed March 5, 2010. 3. Almeida J, Galhenage S, Yu J, Kurtovic J, Riordan SM. Gut flora and bacterial translocation in chronic liver disease. World J Gastroenterol. 2006;12:1493-1502. 4. Pande C, Kumar A, Sarin SK. Small-intestinal bacterial overgrowth in cirrhosis is related to the severity of liver disease. Aliment Pharmacol Ther. 2009;29:1273-1281. 5. Madrid AM, Cumsille F, Defilippi C. Altered small bowel motility in patients with liver cirrhosis depends on severity of liver disease. Dig Dis Sci. 1997;42:738-742. 6. Riordan SM, Skinner N, Nagree A, et al. Peripheral blood mononuclear cell expression of toll-like receptors and relation to cytokine levels in cirrhosis. Hepatology. 2003;37:1154-1164. 7. Xifaxan [prescribing information]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2010.

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