Rifaximin

(Xifaxan®)

Xifaxan®

Drug updated on 9/4/2024

Dosage FormTablet (oral; 200 mg, 550 mg)
Drug ClassAntibacterials
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of travelers’ diarrhea (TD) caused by noninvasive strains of Escherichia coli in adult and pediatric patients 12 years of age and older.
  • Indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.
  • Indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

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Summary
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  • Xifaxan (rifaximin) is indicated for the treatment of travelers’ diarrhea (TD) caused by noninvasive strains of Escherichia coli in adult and pediatric patients 12 years of age and older, the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults, and the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
  • This summary is based on the review of 15 systematic review(s)/meta-analysis(es). [1-15]
  • Abdominal Bloating and FGID: Rifaximin showed a higher likelihood of improvement in bloating symptoms (44.6% vs. 34.6%, RR 1.22, 95% CI 1.11, 1.35, n=2401) and reduced the severity of bloating (SMD -0.3, 95% CI -0.51, -0.1, P=0.04).
  • Hepatic Encephalopathy (HE): Rifaximin reduced the incidence of HE in primary prevention (OR 0.66; 95% CI 0.45, 0.96; p=0.032), lowered the risk of recurrence in patients in remission (OR 0.38; 95% CI 0.28, 0.52; p<0.001), and improved clinical symptoms in MHE and OHE patients (OR 3.76; 95% CI 2.69, 5.25; p<0.001).
  • Alcohol-Associated Hepatitis (AAH): Rifaximin reduced infection rates (RR 0.331, 95% CI 0.159-0.689, P=0.003) but did not significantly impact 90-day and overall mortality.
  • Small Intestinal Bacterial Overgrowth (SIBO): Rifaximin was effective in eradicating SIBO with an overall eradication rate of 63% in per protocol analysis.
  • No significant increase in adverse events was observed with Rifaximin (OR: 0.96; 95% CI: 0.74, 1.24; p=0.749).
  • When compared with nonabsorbable disaccharides (NADs), Rifaximin showed no significant differences in adverse drug effects (OR=0.43, 95% CI=0.10-1.77, P=.24).
  • The Population Types and Subgroup Considerations section includes patients with liver disease at various stages of hepatic encephalopathy (HE), patients with irritable bowel syndrome (IBS) with gastrointestinal symptoms, patients with alcohol-associated hepatitis (AAH) with a focus on infection rates and mortality, and patients with small intestinal bacterial overgrowth (SIBO) with a dose-dependent eradication rate; subgroup analyses for HE include primary and secondary prevention, minimal HE, and combined therapy with lactulose.

Product Monograph / Prescribing Information

Document TitleYearSource
Xifaxan (rifaximin) Prescribing Information.2022Salix Pharmaceuticals, Bridgewater, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy of rifaximin in patients with abdominal bloating or distension: a systematic review and meta-analysis.2024Journal of Clinical Gastroenterology
Preventive and therapeutic effects of rifaximin on hepatic encephalopathy with differential application dosages and strategies: a network meta-analysis.2024BMC Gastroenterology
Systematic review and meta-analysis on the effects of lactulose and rifaximin on patient-reported outcomes in hepatic encephalopathy.2023The American Journal of Gastroenterology
Effectiveness of Rifaximin on the outcomes of irritable bowel syndrome: a systematic review and meta-analysis of randomized controlled trials. 2023Cureus
Efficacy and safety of Rifaximin in the prevention of recurrent episodes of hepatic encephalopathy: a systematic review and meta-analysis. 2023The Turkish Journal of Gastroenterology
Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis.2023The Cochrane Database of Systematic Reviews
Effectiveness of rifaximin on the outcomes of irritable bowel syndrome: a systematic review and meta-analysis of randomized controlled trials.2023Cureus
Efficacy and safety of rifaximin in the prevention of recurrent episodes of hepatic encephalopathy: a systematic review and meta-analysis.2023The Turkish Journal of Gastroenterology
Systematic review and meta-analysis on the effects of lactulose and rifaximin on patient-reported outcomes in hepatic encephalopathy.2023The American Journal of Gastroenterology
Role of rifaximin in the management of alcohol-associated hepatitis: a systematic review and meta-analysis.2023Journal of Gastroenterology and Hepatology
Combination therapy with rifaximin and lactulose in hepatic encephalopathy: a systematic review and meta-analysis.2022PLOS ONE
Is rifaximin better than nonabsorbable disaccharides in hepatic encephalopathy? A meta-analysis.2021Medicine
Efficacy of rifaximin in treating with small intestine bacterial overgrowth: a systematic review and meta-analysis. 2021Expert Review of Gastroenterology and Hepatology
Efficacy of pharmacological therapies in patients with IBS with diarrhoea or mixed stool pattern: systematic review and network meta-analysis.2020Gut
Combination of rifaximin and lactulose improves clinical efficacy and mortality in patients with hepatic encephalopathy.2018Drug Design, Development and Therapy

Clinical Practice Guidelines