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Xifaxan (Rifaximin) - Summary

 
 



XIFAXAN SUMMARY

XIFAXAN tablets contain rifaximin, a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin SV. Rifaximin is a structural analog of rifampin.

        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.

Travelers’ Diarrhea

        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 (5), Clinical Pharmacology (12.4) and Clinical   Studies   (14.1)].

         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.

Hepatic Encephalopathy

        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 (8.7), Clinical Pharmacology].


See all Xifaxan indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Xifaxan (Rifaximin)

FDA approves two therapies to treat IBS-D
Source: Irritable-Bowel Syndrome News From Medical News Today [2015.05.28]
The U.S. Food and Drug Administration has approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with...

Salix's TARGET 3 study examines the safety and efficacy of repeat treatment with Rifaximin for IBS with diarrhea
Source: Irritable-Bowel Syndrome News From Medical News Today [2014.10.23]
Salix Pharmaceuticals, Ltd. has announced that Dr. Anthony Lembo of Beth Israel Deaconess Medical Center will present the results of TARGET 3 in a late-breaking podium presentation at the American...

more news >>

Published Studies Related to Xifaxan (Rifaximin)

Safety and tolerability of rifaximin for the treatment of irritable bowel syndrome without constipation: a pooled analysis of randomised, double-blind, placebo-controlled trials. [2014]
events (AEs) in phase 2b and phase 3 non-C IBS trials... CONCLUSIONS: The safety and tolerability profile of rifaximin during treatment

[Role of rifaximin in the treatment of colonic diverticular disease]. [Article in Italian] [2012]
Diverticular disease of the colon is the fifth most important gastrointestinal disease in terms of direct and indirect healthcare costs in western countries. Although most patients with colonic diverticula remain asymptomatic for their whole life, in 20-25% of cases will develop symptoms.No definitive conclusion can be drawn regard a possible role of rifaximin for preventing diverticulitis.

Double-blind randomized controlled trial of rifaximin for persistent symptoms in patients with celiac disease. [2011.10]
BACKGROUND: Small intestinal bacterial overgrowth (SIBO) is one cause of a poor response to a gluten-free diet (GFD) and persistent symptoms in celiac disease. Rifaximin has been reported to improve symptoms in non-controlled trials. AIMS: To determine the effect of rifaximin on gastrointestinal symptoms and lactulose-hydrogen breath tests in patients with poorly responsive celiac disease... CONCLUSIONS: Rifaximin does not improve patients' reporting of gastrointestinal symptoms and hydrogen breath tests do not reliably identify who will respond to antibiotic therapy.

Rifaximin: new therapeutic indication and future directions. [2011.07]
BACKGROUND: Rifaximin is a nonabsorbable oral antibiotic that acts locally in the gastrointestinal tract with minimal systemic adverse effects. Rifaximin received new labeling for reduction in the risk of the recurrence of overt hepatic encephalopathy (HE) in patients with advanced liver disease in March of 2010. OBJECTIVE: This article reviews the pharmacology, pharmacokinetics, and pharmacodynamics of rifaximin. The efficacy and safety of rifaximin in reducing the risk of the recurrence of overt HE in patients with advanced liver disease, the new US Food and Drug Administration-approved indication, is the focus of this review. Emerging data on the use of rifaximin in irritable bowel syndrome (IBS) and Clostridium difficile infection (CDI) are also evaluated... CONCLUSIONS: Rifaximin can be an effective option for reduction in the risk of the recurrence of HE in patients with advanced liver disease. Studies suggest that rifaximin provides relief of global symptoms of diarrhea-predominant IBS and bloating. Use of rifaximin in CDI requires further study. Copyright (c) 2011 Elsevier HS Journals, Inc. All rights reserved.

Efficacy of levofloxacin and rifaximin based quadruple therapy in Helicobacter pylori associated gastroduodenal disease: a double-blind, randomized controlled trial. [2011.06]
The aim of this study was to evaluate the efficacy of levofloxacin and rifaximin based quadruple regimen as first-line treatment for Helicobacter pylori infection. A prospectively randomized, double-blinded, parallel group, comparative study was performed...

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Reports of Suspected Xifaxan (Rifaximin) Side Effects

Renal Failure (5)Colitis Ischaemic (3)Staphylococcal Infection (3)Pancreatitis (3)Enterococcal Infection (2)Hepatic Failure (2)Headache (2)Fall (2)Bacterial Prostatitis (2)Oedema Peripheral (2)more >>


Page last updated: 2015-05-28

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