OVERVIEW

PRODUCT INFORMATION

CHEMICAL FORMULA AND STRUCTURE

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DRUG	CAS REGISTRY NO	MOLECULAR FORMULA	STRUCTURE
Rifamycin	6998-60-3	C37-H47-N-O12

ANNOTATED BIBLIOGRAPHY

References updated: 11 April 2019

• Zimmerman HJ. Hepatic injury from antimicrobial agents. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999, pp. 598.

  (Expert review of hepatotoxicity published in 1999; rifampin is discussed but not rifamycin or rifaximin).
• Verma S, Kaplowitz N. Hepatotoxicity of antituberculosis drugs. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2013, pp. 483-504.

  (Review of hepatotoxicity of antituberculosis drugs; rifampin can induce microsomal CYP enzymes as well as inhibit bilirubin update or excretion; rifamycin is not discussed).
• https://www​.accessdata​.fda.gov/scripts/cder/daf/

  (FDA Drug Approvals website that has product labels [package inserts], letters of approval and full FDA scientific review of the new drug application for safety and efficacy; mentions that serum enzyme elevations were uncommon during rifamycin therapy and no more frequent that with placebo or a comparator therapy [ciprofloxacin]; two subjects developed elevations in serum bilirubin with concurrent increases in ALT and AST, but in both instances the abnormalities were not thought to be due to rifamycin).
• DuPont HL, Jiang ZD, Okhuysen PC, Ericsson CD, de la Cabada FJ, Ke S, DuPont MW, et al. A randomized, double-blind, placebo-controlled trial of rifaximin to prevent travelers' diarrhea. Ann Intern Med 2005; 142: 805-12. [PubMed: 15897530]

  (In a trial in 210 adult US student-travelers to Mexico randomized to take rifaximin or placebo for 2 weeks, there was a decrease in diarrheal illness with rifaximin [15% vs 54%]; there were no "clinically significant" patterns of laboratory abnormalities found).
• Steffen R, Hill DR, DuPont HL. Traveler's diarrhea: a clinical review. JAMA 2015; 313 (1): 71-80. [PubMed: 25562268]

  (Review of the incidence, etiology and management of travelers’ diarrhea; rates vary from 10-40% largely dependent upon the destination and duration of exposure, as well as where meals are purchased; causes include enterotoxigenic E. coli, noroviruses, Salmonella, Shigella and Campylobacter species; prevention depends on dietary precautions; prophylaxis and treatments include bismuth subsalicylate, ciprofloxacin and rifaximin; complications may include bloody diarrhea, post-infectious irritable bowel syndrome, reactive arthritis, and Guillain-Barre syndrome).
• DuPont HL, Petersen A, Zhao J, Mundt A, Jiang ZD, Miller S, Flores J, et al. Targeting of rifamycin SV to the colon for treatment of travelers' diarrhea: a randomized, double-blind, placebo-controlled phase 3 study. J Travel Med 2014; 21: 369-76. [PubMed: 25345982]

  (Among 264 patients with travelers’ diarrhea treated with a 3-day course of rifamycin or placebo, the duration of diarrhea was shorter [46 vs 68 hours] and clinical cure rate higher [81% vs 57%] with rifamycin, while advance event rates were lower [30% vs 38.5%] and “no drug effects on renal or liver function test results were identified”).
• Jiang ZD, DuPont HL. Etiology of travellers' diarrhea. J Travel Med 2017; 24 (suppl_1): S13-S16. [PubMed: 28521001]

  (Review of 11 studies on the etiology of travelers’ diarrhea; overall bacterial pathogens were identified in 72-80% of cases, most commonly E. coli and for non-bacterial cases, norovirus in 3-10%).
• Steffen R, Jiang ZD, Gracias Garcia ML, Araujo P, Stiess M, Nacak T, GreinwaldR, DuPont HL. Rifamycin SV-MMX® for treatment of travelers' diarrhea: equally effective as ciprofloxacin and not associated with the acquisition of multi-drug resistant bacteria. J Travel Med 2018; 25 (1). [PMC free article: PMC6331114] [PubMed: 30462260]

  (Among 835 travelers with diarrhea treated with rifamycin [400 mg twice daily] or ciprofloxacin [500 mg twice daily] for 3 days, time to cure was similar [43 vs 37 hours] as were adverse event rates [8.1% vs 7.5%] and no serious adverse events occurred).
• Rifamycin (Aemcolo) for treatment of travelers' diarrhea. Med Lett Drugs Ther 2019; 61 (1567): 39-40. [PubMed: 30845098]

  (Concise review of the mechanism of action, clinical efficacy, safety and costs of rifamycin shortly after its approval as therapy of travelers' diarrhea in the US, does not mention ALT elevations or hepatotoxicity).