"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
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To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN 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.
XIFAXAN 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 PHARMACOLOGYand Clinical Studies].
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.
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. 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, Use in Specific Populations, CLINICAL PHARMACOLOGY].
DOSAGE AND ADMINISTRATION
Dosage For Travelers' Diarrhea
The recommended dose of XIFAXAN is one 200 mg tablet taken orally three times a day for 3 days. XIFAXAN can be administered orally, with or without food [see CLINICAL PHARMACOLOGY].
Dosage For Hepatic Encephalopathy
The recommended dose of XIFAXAN is one 550 mg tablet taken orally two times a day, with or without food [see CLINICAL PHARMACOLOGY].
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.
- 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
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
NDC 65649-303-03, carton of 60 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.
Manufactured for: Salix Pharmaceuticals, Inc. Raleigh, NC 27615. Revised: March 2014
Last reviewed on RxList: 3/28/2014
This monograph has been modified to include the generic and brand name in many instances.
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