Taking Xifaxan550 for overt HE
What should you expect while taking Xifaxan550?
In the scientific study of Xifaxan 550 mg, researchers kept track of the side effects happening to adults taking Xifaxan 550 mg compared to those who didn't take Xifaxan 550 mg.
The researchers found that patients with overt hepatic encephalopathy (HE) who took Xifaxan 550 mg had similar side effects as the group who didn't take Xifaxan 550 mg. The most common side effects occurring in >8% of patients in the study were edema peripheral (15%), nausea (14%), dizziness (13%), fatigue (12%), ascites (11%), muscle spasms (9%), pruritus (9%), and abdominal pain (9%). Talk to your doctor about potential side effects you may experience while taking Xifaxan 550 mg.
When should you take Xifaxan550?
Xifaxan 550 mg should be taken 2 times a day, 1 pill each time. Xifaxan 550 mg can be taken with or without food. Getting on a schedule is a great way to ensure that medicine gets taken as the doctor ordered.
Can you take other medicines while taking Xifaxan550?
As with all medications, you should talk to your doctor about the medications you are currently taking before you begin treatment with Xifaxan 550 mg.
Learn about hepatic encephalopathy
Discover the importance of treating overt HE
Explore resources for adults living with overt HE and
their caregivers
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
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