XIFAXAN SUMMARY
XIFAXAN™ (rifaximin) Tablets
(zuh FAX in)
XIFAXAN™ Tablets contain rifaximin, a semi-synthetic, non-systemic antibiotic.
XIFAXAN™ Tablets are indicated for the treatment of patients (>/=12 years of age) with travelers' diarrhea caused by noninvasive strains of Escherichia coli (see WARNINGS, Microbiology, and CLINICAL STUDIES).
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.
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NEWS HIGHLIGHTS
Published Studies Related to Xifaxan (Rifaximin)
A randomized, double-blind, placebo-controlled trial of rifaximin, a nonabsorbable antibiotic, in the treatment of tropical enteropathy. [2009.09]
OBJECTIVES: Tropical enteropathy is characterized by an increased urinary lactulose-to-mannitol (L:M) ratio on a site-specific sugar absorption test and is associated with increased intestinal permeability and decreased nutrient absorptive capacity. The etiology of tropical enteropathy is postulated to be intestinal bacterial overgrowth. This study tested the hypothesis that treatment with a nonabsorbable, broad-spectrum antibiotic, rifaximin, reduces the L:M ratio in rural Malawian children, among whom tropical enteropathy is common... CONCLUSIONS: Rifaximin had no effect on the tropical enteropathy of 3-5-year-old Malawian children, suggesting that small-bowel bacterial overgrowth is not an important etiological factor in this condition.
Antibiotic therapy in small intestinal bacterial overgrowth: rifaximin versus metronidazole. [2009.03]
BACKGROUND AND OBJECTIVES: Few controlled trials on antibiotic therapy for small intestinal bacterial overgrowth are available at present. Aim of the study was to assess efficacy, safety and tolerability of rifaximin with respect to metronidazole for the treatment of small intestinal bacterial overgrowth...
Rifaximin for maintenance therapy in antibiotic-dependent pouchitis. [2008.06.23]
BACKGROUND: Pouchitis is the most common long-term complication of in patients with restorative proctocolectomy and ileal pouch-anal anastomosis. Patients often develop antibiotic-dependent form of pouchitis requiring long-term antibiotic therapy for remission maintenance. Rifaximin, an oral, non-systemic, broad-spectrum antibiotic with a favorable safety profile, may be a promising candidate agent for maintenance therapy. This historical cohort open-label study investigated the efficacy and tolerability of rifaximin in maintaining symptomatic and endoscopic remission in patients with antibiotic-dependent pouchitis... CONCLUSION: Patients' response to rifaximin as a maintenance therapy appears to be favorable in this open-labeled trial of antibiotic-dependent pouchitis. Randomized, placebo-controlled trials with a longer follow-up are warranted.
Rifaximin for the treatment of active pouchitis: A randomized, double-blind, placebo-controlled pilot study. [2007.10]
Background: The efficacy of the nonabsorbable antibiotic rifaximin in patients with active acute or chronic pouchitis is unknown.Methods: We performed a placebo-controlled pilot trial to evaluate the efficacy and safety of rifaximin in patients with active pouchitis... A larger trial would be required to determine if rifaximin is effective for the treatment of active pouchitis.
Rifaximin for the treatment of active pouchitis: A randomized, double-blind, placebo-controlled pilot study. [2007.06.13]
Background: The efficacy of the nonabsorbable antibiotic rifaximin in patients with active acute or chronic pouchitis is unknown.Methods: We performed a placebo-controlled pilot trial to evaluate the efficacy and safety of rifaximin in patients with active pouchitis... A larger trial would be required to determine if rifaximin is effective for the treatment of active pouchitis.
Clinical Trials Related to Xifaxan (Rifaximin)
Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome [Completed]
This is placebo-controlled study of three rifaximin doses in patients with DIBS. Subjects
will be randomized to receive daily doses of placebo BID, rifaximin 275 mg BID, rifaximin 550
mg BID, or 1100 mg BID for 14 days. These four groups will subsequently receive an
additional two weeks of placebo for a total of 4 weeks of treatment. A fifth group of
subjects will receive rifaximin 550 mg BID for a period of 28 days. Subjects who successfully
respond to treatment at the end of the 28-day Treatment Phase will be followed in a
Post-treatment Phase that includes study visits during Weeks 6, 8, 12 and 16. Subjects who
relapse during the Post-treatment Phase will be discontinued from the study.
Induction of Clinical Response Using Rifaximin in Crohn's Disease [Recruiting]
Antibiotics have been used to treat Crohn's disease symptoms with the best studied
antibiotics being Cipro and Flagyl. Rifaximin is a poorly absorbed oral antibiotic that is
FDA approved for travelers' diarrhea. It works by inhibiting bacterial reproduction. It is
very poorly absorbed and over 97% of the drug taken orally is excreted in the feces.
The purpose of this study is to evaluate the potential benefits and safety of Rifaximin for
the treatment of moderate to severe symptoms of Crohn's Disease.
Rifaximin for Preventing Acute Graft Versus Host Disease (AGVHD) [Recruiting]
Acute graft versus host disease is a frequent and often life threatening complication of
allogeneic blood and marrow transplantation. The bacteria that normally reside in the
intestine play a critical role in its development. Injury to the lining of the bowel that
results from the high dose chemotherapy or radiation that transplant patients receive during
the week preceding the transplant allows the bacteria to invade the intestines and spread to
nearby lymph nodes. This, in turn, causes inflammation which has been shown to promote
GVHD. Both pre-clinical and clinical research has demonstrated that oral antibiotics can
prevent graft versus host disease by inhibiting these gut bacteria. Rifaximin has several
features that suggest it could be effective in preventing GVHD. Rifaximin prophylaxis might
also provide an added benefit by protecting highly immunocompromised transplant patients
from severe bacterial infections. This pilot trial will allow the investigators to determine
the feasibility of using Rifaximin for prevention of GVHD and infection in patients
undergoing allogeneic blood and marrow transplantation. The preliminary results will be
used to plan a more definitive trial.
Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's Disease [Recruiting]
This study aims to determine which of 3 doses of a non-absorbable antibiotic Rifaximin is
most effective in treating active moderate Crohn's disease. Rifaximin tablets are already
marketed in some European countries and the USA to treat traveller's diarrhoea. A new
gastro-resistant form of Rifaximin called Rifaximin-Extended Intestinal Release (EIR) will
be used in this study. These tablets dissolve in the stomach,releasing gastro-resistant
granules which pass into the intestines and deliver Rifaximin directly to the site of the
disease. Rifaximin is not absorbed, making it more effective and greatly reducing the
frequency of side effects.
A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) [Recruiting]
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