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rifaximin (Xifaxan, Fatroximin, Normix)
Tradename: Xifaxam
Indications:
1) traveler's diarrhea (noninvasive Escherichia coli)
2) irritable bowel syndrome (IBS) [3,6], FDA-approved [7]
3) reduces recurrence of overt hepatic encephalopathy in patients with advanced liver disease [4]
4) small intestinal bacterial overgrowth
Dosage:
1) 200 mg TID for 3 days (with or without food) [1]
2) 200 mg QD-TID for 2 weeks [2]
3) 550 mg TID for 2 weeks (IBS) [6]
4) hepatic encephalopathy: 550 mg BID [9]
Tabs: 200 mg, 550 mg
Pharmacokinetics:
1) not absorbed systemically (< 0.4%)
2) induces cyt P450 3A4, but drug is absorbed
Adverse effects:
- headache
- peripheral edema
- nausea, constipation
- dizziness, fatigue, insomnia
- urinary tract infection
- anemia
- pruritus
- ascites
- elevated serum ALT [9]
Drug interactions:
- warfarin (dosage adjustment may be needed to maintain target INR) [9]
Mechanism of action:
- inhibits bacterial RNA synthesis by binding to beta-subunit of bacterial DNA-dependent RNA polymerase
Notes:
- cost (2010) for prevention of hepatic encephalopathy about $1200/month [5]
Interactions
drug interactions
General
antiprotozoal agent
rifamycin (rifamycin SV, Rifocin, Aemcolo)
Properties
MISC-INFO: pregnancy-category C
Database Correlations
PUBCHEM cid=72111
References
- Prescriber's Letter 11(7):38 2004
Detail-Document#: 200706
(subscription needed) http://www.prescribersletter.com
- Journal Watch 25(13):103, 2005
DuPont HL, Jiang ZD, Okhuysen PC, Ericsson CD, de la Cabada FJ,
Ke S, DuPont MW, Martinez-Sandoval F.
A randomized, double-blind, placebo-controlled trial of
rifaximin to prevent travelers' diarrhea.
Ann Intern Med. 2005 May 17;142(10):805-12. Summary for
patients in: Ann Intern Med. 2005 May 17;142(10):I30.
PMID: 15897530
- Pimentel M, Park S, Mirocha J, Kane SV, Kong Y.
The effect of a nonabsorbed oral antibiotic (rifaximin) on
the symptoms of the irritable bowel syndrome: a randomized
trial.
Ann Intern Med. 2006 Oct 17;145(8):557-63.
Summary for patients in: Ann Intern Med. 2006,145(8):I24.
PMID: 17043337
- Drossman DA.
Treatment for bacterial overgrowth in the irritable bowel
syndrome.
Ann Intern Med. 2006 Oct 17;145(8):626-8. (No abstract)
PMID: 17043344
- FDA NEWS RELEASE, March 24, 2010
FDA Approves New Use of Xifaxan for Patients with Liver Disease
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm206104.htm
- Bass NM, Mullen KD, Sanyal A et al
Rifaximin treatment in hepatic encephalopathy.
N Engl J Med. 2010 Mar 25;362(12):1071-81
PMID: 20335583
- Prescriber's Letter 17(6): 2010
Rifaximin (Xifaxan) for Hepatic Encephalopathy
Detail-Document#: 260608
(subscription needed) http://www.prescribersletter.com
- Sidhu SS et al.
Rifaximin improves psychometric performance and health-related
quality of life in patients with minimal hepatic encephalopathy
(The RIME Trial).
Am J Gastroenterol 2011 Feb; 106:307.
PMID: 21157444
- Bajaj JS et al.
Rifaximin improves driving simulator performance in a
randomized trial of patients with minimal hepatic
encephalopathy.
Gastroenterology 2011 Feb; 140:478.
PMID: 20849805
- Pimentel M et al
Rifaximin Therapy for Patients with Irritable Bowel Syndrome
without Constipation
N Engl J Med. 2011 Jan 6;364(1):22-32.
PMID: 21208106
http://www.nejm.org/doi/full/10.1056/NEJMoa1004409
- Tack J
Antibiotic Therapy for the Irritable Bowel Syndrome
N Engl J Med. 2011 Jan 6;364(1):81-2.
PMID: 21208112
http://www.nejm.org/doi/full/10.1056/NEJMe1011211
- FDA News Release. May 27, 2015
FDA approves two therapies to treat IBS-D
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm448328.htm
- NEJM Knowledge+ Gastroenterology
- HIGHLIGHTS OF PRESCRIBING INFORMATION
XIFAXAN (rifaximin) tablets, for oral use
https://shared.salix.com/globalassets/pi/xifaxan550-pi.pdf