title: Cethromycin: a new ketolide antibiotic.
abstract: OBJECTIVE
  To review the pharmacology, chemistry, microbiology, in vitro susceptibility, mechanism of resistance, pharmacokinetics, pharmacodynamics, clinical efficacy, safety, drug interactions, dosage, and administration of cethromycin, a new ketolide antibiotic.
  
  
  METHODS
  Literature was obtained through searching PubMed (1950-October 2012), International Pharmaceutical Abstracts (1970-October 2012), and a bibliographic review of published articles. Search terms included cethromycin, ABT-773, ketolide antibiotic, and community-acquired pneumonia.
  
  
  METHODS
  All available in vitro and preclinical studies, as well as Phase 1, 2, and 3 clinical studies published in English were evaluated to summarize the pharmacology, chemistry, microbiology, efficacy, and safety of cethromycin in the treatment of respiratory tract infections.
  
  
  RESULTS
  Cethromycin, a new ketolide, has a similar mechanism of action to telithromycin with an apparently better safety profile. Cethromycin displays in vitro activity against selected gram-positive, gram-negative, and atypical bacteria. The proposed indication of cethromycin is treatment of mild to moderate community-acquired bacterial pneumonia in patients aged 18 years or older. Based on clinical studies, the recommended dose is 300 mg orally once a day without regard to meals. Cethromycin has an orphan drug designation for tularemia, plague, and anthrax prophylaxis. The Food and Drug Administration denied approval for the treatment of community-acquired pneumonia in 2009; a recent noninferiority trial showed comparable efficacy between cethromycin and clarithromycin. Preliminary data on adverse effects suggest that cethromycin is safe and gastrointestinal adverse effects appear to be dose-related.
  
  
  CONCLUSIONS
  Cethromycin appears to be a promising ketolide for the treatment of mild to moderate community-acquired pneumonia. It was denied approval by the FDA in 2009 pending more evidence to show its efficacy, with more recent studies showing its noninferiority to antibiotics for the same indication.
authors: College of Pharmacy, University of Florida, FL, USA. Hanine.mansour@lau.edu.lb
authors: Hanine
authors: H
authors: Mansour
authors: Elias B
authors: EB
authors: Chahine
authors: Lamis R
authors: LR
authors: Karaoui
authors: Rania M
authors: RM
authors: El-Lababidi
mesh_terms: D000818:Animals; D000900:Anti-Bacterial Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D017714:Community-Acquired Infections / Q000188:drug therapy; D004347:Drug Interactions; D024881:Drug Resistance, Bacterial; D006801:Humans; D048628:Ketolides / Q000494:pharmacology / Q000627:therapeutic use*; D008826:Microbial Sensitivity Tests
chemical_list: D000900:Anti-Bacterial Agents; D048628:Ketolides; C405499:cethromycin