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

Other HE treatment options

Nonabsorbable disaccharides

Lactulose has been considered the standard of treatment for HE, with clinical studies showing about 50% of patients experiencing improvement.1,2

Antibiotics

Several antibiotics that have activity in the small bowel, although not all approved for HE, have been shown to reduce symptoms of encephalopathy.4

Learn more about Xifaxan 550 mg.

See how Xifaxan 550 mg may reduce hospitalizations.

Xifaxan550 Frequently Asked Questions Watch a Video on Gut Flora and Hepatic Encephalopathy Sign up for Xifaxan550 Updates
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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. Muñoz SJ. Hepatic encephalopathy. Med Clin North Am. 2008;92(4):795-812. 2. Als-Nielsen B, Gluud LL, Gluud C. Non-absorbable disaccharides for hepatic encephalopathy: systematic review of randomised trials. Br Med J. 2004;328(7447):1046. 3. Bajaj JS, Sanyal AJ, Bell D, Gilles H, Heuman DM. Predictors of the recurrence of hepatic encephalopathy in lactulose-treated patients. Aliment Pharmacol Ther. 2010; 31(9):1012-1017. 4. Blei AT, Cordoba J, Practice Parameters Committee of the American College of Gastroenterology. Practice guidelines: hepatic encephalopathy. Am J Gastroenterol. 2001;96(7):1968-1976.

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