Tolerability profile
Nonsystemic Xifaxan 550 mg has a safety and tolerability profile comparable to placebo
when used as directed1
*Most common adverse reactions occuring in ≥8% of patients taking Xifaxan 550 mg.1,2
†91% were using lactulose concomitantly.1
- No known clinically relevant drug-drug interactions3‡
- Xifaxan has not been shown to cause clinically relevant resistance when used as
directed4,5
‡The effect of rifaximin on CYP3A4 in patients
with impaired liver function who have elevated systemic exposure is not known.
Discover twice-daily dosing.
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.
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. Bass NM, Mullen KD, Sanyal A, et al. Rifaximin treatment
in hepatic encephalopathy. N Engl J Med. 2010;362(12):1071-1081 2.
Data on file, Salix Pharmaceuticals, Inc. 3. Xifaxan [precscribing
information]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2010. 4.
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.
5. Koo H, DuPont H. Current and future developments in travelers’
diarrhea therapy. Expert Rev Anti Infect Ther. 2006;4(3):417-427.