title: Fidaxomicin: a novel macrolide antibiotic for Clostridium difficile infection.
abstract: OBJECTIVE
  To review the chemistry, pharmacology, microbiology, pharmacodynamics, pharmacokinetics, clinical efficacy, tolerability, drug interactions, dosing, and administration of fidaxomicin (FDX).
  
  
  METHODS
  A search of PubMed using the terms "fidaxomicin," "OPT-80," "PAR-101," "OP-1118," "difimicin," "tiacumicin," and "lipiarmycin" was performed. All English-language articles from 1983 to November 2013 were reviewed for relevance. Bibliographies of all articles were reviewed as well as the manufacturer's Web site to further identify relevant information.
  
  
  METHODS
  All English-language articles from 1983 to November 2013 appearing in these searches were reviewed for relevance to this paper. In addition, their bibliographies were reviewed to identify any articles not identified in the searches.
  
  
  RESULTS
  FDX is the first macrolide antibiotic with a narrow spectrum of activity targeted against Clostridium difficile. It is administered orally without regard to food. The primary route of elimination is fecal excretion. Advanced age, hepatic dysfunction, or renal impairment do not alter its disposition. Phase III clinical trials have demonstrated that FDX 200 mg twice daily for 10 days is noninferior to vancomycin 125 mg four times daily for 10 days in the treatment of adults with C. difficile infection and is associated with lower recurrence rates. FDX has a favorable side effect profile and a low potential for drug interactions.
  
  
  CONCLUSIONS
  FDX has been shown to be safe and effective in the treatment of adults with C. difficile infection. Further research and pharmacoeconomic studies are needed to clarify and refine its role in the treatment of patients at high risk for recurrence.
authors.affiliation: Lloyd L. Gregory School of Pharmacy, Palm Beach Atlantic University, West Palm Beach, Florida, USA.
authors.forename: Elias B
authors.initials: EB
authors.lastname: Chahine
authors.forename: Allana J
authors.initials: AJ
authors.lastname: Sucher
authors.forename: Karelee
authors.initials: K
authors.lastname: Mantei
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000617:Aminoglycosides / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016360:Clostridioides difficile / Q000187:drug effects*; D004347:Drug Interactions; D004761:Enterocolitis, Pseudomembranous / Q000188:drug therapy* / Q000378:metabolism / Q000382:microbiology / Q000517:prevention & control; D000077732:Fidaxomicin; D006801:Humans; D066237:Intestinal Elimination; D018942:Macrolides / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D019384:Nucleic Acid Synthesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D012008:Recurrence; D014018:Tissue Distribution
chemical_list: D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D018942:Macrolides; D019384:Nucleic Acid Synthesis Inhibitors; D000077732:Fidaxomicin