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

Twice-daily dosing

Xifaxan 550 mg—one 550 mg tablet taken twice daily1

Xifaxan 550 mg — twice daily

*The effect of rifaximin on CYP3A4 in patients with impaired liver function who have elevated systemic exposure is not known.

Learn more about long-term safety in patients with HE.

Learn how Xifaxan 550 mg reduces risk of overt HE recurrence.

Xifaxan550 Frequently Asked Questions Learn About the Hepatic Encephalopathy Living Program Read the NEJM article, Rifaximin Treatment in HE
Xifaxan 550 mg (rifaximin) quarter-circle

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%).

Complete Prescribing Information.PDF

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

Reference: 1. Xifaxan [prescribing information]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2010.

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