To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN (rifaximin) and other antibacterial drugs, XIFAXAN (rifaximin) when used to treat infection should be used only to treat or prevent infections that are proven 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.

Travelers'Diarrhea

XIFAXAN (rifaximin) 200 mg is indicated for the treatment of patients ( ≥ 12 years of age) with travelers' diarrhea caused by noninvasive strains of Escherichia coli [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY and Clinical Studies].

Limitations of Use

XIFAXAN (rifaximin) 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.

Hepatic Encephalopathy

XIFAXAN (rifaximin) 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 (rifaximin) 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 (rifaximin) has not been studied in patients with MELD (Model for End101 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, Use in Specific Populations, CLINICAL PHARMACOLOGY].

Dosage for Travelers' Diarrhea:

The recommended dose of XIFAXAN (rifaximin) is one 200 mg tablet taken orally three times a day for 3 days. XIFAXAN (rifaximin) can be administered orally, with or without food [see CLINICAL PHARMACOLOGY].

Dosage for Hepatic Encephalopathy

The recommended dose of XIFAXAN (rifaximin) is one 550 mg tablet taken orally two times a day, with or without food [see CLINICAL PHARMACOLOGY].

Dosage Forms And Strengths

XIFAXAN (rifaximin) is pink-colored biconvex tablets and is available in the following strengths:

• 200 mg – a round tablet debossed with “Sx” on one side.
• 550 mg – an oval tablet debossed with “rfx” on one side.

Storage And Handling

The 200 mg tablet is a pink-colored, round, biconvex tablet with “Sx” debossed on one side. It is available in the following presentations:

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

The 550 mg tablet is a pink-colored, oval, biconvex tablet with “rfx” debossed on one side. It is available in the following presentations:

NDC 65649-303-02, bottles of 60 tablets
NDC 65649-303-03, carton of 60 tablets, Unit Dose

Storage

Store XIFAXAN (rifaximin) Tablets at 20–25°C (68–77°F); excursions permitted to 15–30°C (59-86°F). See USP Controlled Room Temperature.

Manufactured for: Salix Pharmaceuticals, Inc., Morrisville, NC 27560, under license from Alfa Wassermann S.p.A. Web site: www.Salix.com, E-mail: customer.service@salix.com, 1700 Perimeter Park Drive, Morrisville, NC 27560, Tel.866-669-SLXP (7597).

Last reviewed on RxList: 4/19/2010
This monograph has been modified to include the generic and brand name in many instances.