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Tolerability profile

Nonsystemic Xifaxan 550 mg offers safety and tolerability when used as directed1

*Most common adverse reactions occuring in ≥8% of patients taking Xifaxan 550 mg.

• No known clinically relevant drug-drug interactions.1†
• Xifaxan has not been shown to cause clinically relevant resistance when used as directed.3,4

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

Discover twice-daily dosing.

Explore gut flora and its role in HE.

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.

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

References: 1. Xifaxan [prescribing information]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2010. 2. Data on file, Salix Pharmaceuticals, Inc. 3. De Leo C, Eftimiadi C, Schito GC. Rapid disappearance from the intestinal tract of bacteria resistant to rifaximin. Drugs Exp Clin Res. 1986;12:979-981. 4. Koo H, DuPont H. Current and future developments in travelers’ diarrhea therapy. Expert Rev Anti Infect Ther. 2006;4(3):417-427.