ven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1.1 Travelers’ Diarrhea
XIFAXAN is indicated for the treatment of travelers’ diarrhea (TD) caused by noninvasive strains of Escherichia coli in adults and pediatric patients 12 years of age and older.
Limitations of Use
XIFAXAN should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli [see Warnings and Precautions (5.1), Clinical Pharmacology (12.4), Clinical Studies (14.1)].
1.2 Hepatic Encephalopathy
XIFAXAN is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.
In the trials of XIFAXAN for HE, 91% of the patients were using lactulose concomitantly. Differences in the treatment effect of those patients not using lactulose concomitantly could not be assessed.
XIFAXAN has not been studied in patients with MELD (Model for End-Stage Liver Disease) 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 [see Warnings and Precautions (5.4), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
1.3 Irritable Bowel Syndrome with Diarrhea
XIFAXAN is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
2 DOSAGE AND ADMINISTRATION
2.1 Dosage for Travelers’ Diarrhea
The recommended dose of XIFAXAN is one 200 mg tablet taken orally three times a day for 3 days.
2.2 Dosage for Hepatic Encephalopathy
The recommended dose of XIFAXAN is one 550 mg tablet taken orally two times a day.
2.3 Dosage for Irritable Bowel Syndrome with Diarrhea
The recommended dose of XIFAXAN is one 550 mg tablet taken orally three times a day for 14 days. Patients who experience a recurrence of symptoms can be retreated up to two times with the same dosage regimen.
2.4 Administration
XIFAXAN can be taken with or without food [see Clinical Pharmacology (12.3)].
3 DOSAGE FORMS AND STRENGTHS
XIFAXAN is a pink-colored biconvex tablet and is available in the following strengths:
•200 mg – a round tablet debossed with “Sx” on one side and plain on the other.
•550 mg – an oval tablet debossed with “rfx” on one side and plain on the other.
4 CONTRAINDICATIONS
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 [see Adverse Reactions (6.2)].
5 WARNINGS AND PRECAUTIONS
5.1 Travelers’ Diarrhea Not Caused by Escherichia coli
XIFAXAN was not found to be effective in patients with diarrhea complicated by fever and/or blood in the stool or diarrhea due to pathogens other than Escherichia coli.
Discontinue XIFAXAN if diarrhea symptoms get worse or persist more than 24 to 48 hours and alternative antibiotic therapy should be considered.
XIFAXAN is not effective in cases of travelers’ diarrhea due to Campylobacter jejuni. The effectiveness of XIFAXAN in travelers’ |
