Frequently asked questions
What is overt hepatic encephalopathy?
Overt hepatic encephalopathy is a chronic condition that usually occurs in patients with liver disease. Buildup of ammonia and other toxins
normally filtered by the liver can cause a variety of mental and physical symptoms.
What are the symptoms of overt hepatic encephalopathy?
An overt episode of hepatic encephalopathy may result in hospitalization of the patient, or may present as more subtle symptoms, such as confusion/disorientation, asterixis, or day/night reversal.
What is Xifaxan 550 mg?
Xifaxan 550 mg is a nonsystemic antibiotic (works only in the gut) indicated to reduce the risk of overt hepatic encephalopathy recurrence in patients ≥18 years of age.
Learn more about how Xifaxan 550 mg works.
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What is the indication for Xifaxan 550 mg?
Xifaxan 550 mg is indicated for reduction in risk of overt hepatic encephalopathy recurrence in patients ≥18 years of age.
Learn more about the treatment of HE.
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What is the contraindication for Xifaxan 550 mg?
Xifaxan is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in Xifaxan.
See Important Safety Information for Xifaxan 550 mg.
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What is the dosing schedule for Xifaxan 550 mg?
The recommended dose of Xifaxan 550 mg for hepatic encephalopathy is one 550 mg tablet taken twice daily with or without food. Based on the results of clinical drug-drug interaction studies and in vitro induction and inhibition studies, no clinically relevant drug interactions are anticipated with Xifaxan 550 mg.*
*The effect of rifaximin on CYP3A4 in patients with impaired liver function who have elevated systemic exposure is not known.
Learn more about twice-daily dosing.
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What are the most common adverse reactions associated with Xifaxan 550 mg?
In clinical trials, Xifaxan 550 mg was generally well tolerated. 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%).
View the tolerability profile of Xifaxan 550 mg.
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Can I prescribe Xifaxan 550 mg to women who are pregnant?
Xifaxan has not been studied in women who are pregnant or nursing—Pregnancy Category C.
See Important Safety Information for Xifaxan 550 mg.
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Can I prescribe Xifaxan 550 mg to children?
Xifaxan 550 mg for hepatic encephalopathy is not approved for use in children under 18 years of age.
See Important Safety Information for Xifaxan 550 mg.
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Who should not take Xifaxan 550 mg?
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.
Xifaxan 550 mg has not been shown to cause interactions with other drugs. However, it is always important that you ask your patients about any other medications they may be taking before starting treatment with Xifaxan 550 mg.†
†The effect of rifaximin on CYP3A4 in patients with impaired liver function who have elevated systemic exposure is not known.
See Important Safety Information for 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.
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