Frequently Asked Questions
This information is intended for U.S. Healthcare Professionals only.
How do XIFAXAN® (rifaximin) Tablets work?
Rifaximin acts by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase resulting in inhibition of bacterial RNA synthesis.
back to top
What is the dose of XIFAXAN Tablets?
XIFAXAN® Tablets can be administered orally with or without food. For travelers’ diarrhea, the recommended dose is one 200 mg tablet taken three times a day for 3 days.
back to top
How is XIFAXAN supplied?
XIFAXAN Tablets are available as circular, pink-colored, biconvex tablets containing 200 mg rifaximin, debossed with "Sx" on one side.
NDC 65649-301-03 Bottles of 30 tablets
NDC 65649-301-41 Bottles of 100 tablets
NDC 65649-301-05 Carton of 100 Tablets, Unit Dose
Store XIFAXAN Tablets at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.
back to top
How should XIFAXAN be stored?
Store XIFAXAN Tablets at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.
back to top
Who should not take XIFAXAN?
XIFAXAN Tablets 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.
XIFAXAN Tablets are contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN Tablets.
back to top
Can XIFAXAN be used in pregnancy?
Pregnancy category C: XIFAXAN Tablets should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
back to top
What are the most common adverse events for XIFAXAN?
The safety of XIFAXAN Tablets 200 mg taken three times a day (TID) was evaluated in 320 patients in two placebo-controlled clinical trials with 95% of patients receiving at least three days of treatment with XIFAXAN Tablets. All adverse events for XIFAXAN Tablets 200 mg TID that occurred at a frequency > 2% in the two placebo-controlled trials combined are provided in the table listed below. (These include adverse events that may be attributable to the underlying disease.)
All Adverse Events With an Incidence >2% Among Patients Receiving XIFAXAN® Tablets, 600 mg/day, in Placebo-Controlled Studies
| MedDRA Preferred Term |
Number (%) of Patients |
XIFAXAN Tablets, 600mg/day
(N = 320) |
Placebo
N = 228 |
Flatulence
Headache
Abdominal Pain NOS
Rectal Tenesmus
Defecation Urgency
Nausea
Constipation
Pyrexia
Vomiting NOS
|
36 (11.3%)
31 (9.7%)
23 (7.2%)
23 (7.2%)
19 (5.9%)
17 (5.3%)
12 (3.8%)
10 (3.1%)
7 (2.2%)
|
45 (19.7%)
21 (9.2%)
23 (10.1%)
20 (8.8%)
21 (9.2%)
19 (8.3%)
8 (3.5%)
10 (4.4%)
4 (1.8%)
|
back to top
SAFETY CONSIDERATIONS
Xifaxan® (rifaximin) Tablets are indicated for the treatment of patients (≥12 years of age) with travelers’ diarrhea caused by noninvasive strains of
Escherichia coli. 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. Xifaxan should be
discontinued if diarrhea symptoms get worse or persist more than 24-48 hours and alternative antibiotic therapy should be considered. Escherichia coli has been shown to develop resistance to rifaximin in vitro. However, the clinical significance of such an effect has not been studied.
In clinical trials, Xifaxan was generally well tolerated. The most common side effects (vs. placebo) were flatulence 11.3% (vs. 19.7%), headache 9.7% (vs. 9.2%), abdominal pain 7.2% (vs. 10.1%), rectal tenesmus 7.2%
(vs. 8.8%), defecation urgency 5.9% (vs. 9.2%) and nausea 5.3% (vs. 8.3%).
For complete Prescribing Information, please click here.
For product information, adverse event reports, and product complaint reports please call:
Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: