title: Safety of inhaled (Tobi®) and intravenous tobramycin in young children with cystic fibrosis.
abstract: BACKGROUND
  Use of inhaled tobramycin therapy for treatment of Pseudomonas aeruginosa infections in young children with cystic fibrosis (CF) is increasing. Safety data for pre-school children are sparse.
  
  
  METHODS
  The aim of this study was to assess the safety of tobramycin solution for inhalation (TOBI®-TSI) administered twice daily for 2 months/course concurrently to intravenous (IV) tobramycin during P. aeruginosa eradication therapy in children (0-5 years). Audiological assessment and estimation of glomerular filtration rate (GFR) was measured prior to any exposure and end of the study.
  
  
  RESULTS
  Data were available from 142 patients who were either never exposed to aminoglycosides (n=39), exposed to IV aminoglycosides only (n=36) or exposed to IV+TSI (n=67). Median exposure to TSI was 113 days [59, 119]. Comparison of effects on audiometry results and GFR, showed no detectable difference between the groups.
  
  
  CONCLUSIONS
  Use of TSI and IV tobramycin in pre-school children with CF was not associated with detectable renal toxicity or ototoxicity.
authors.affiliation: School of Pharmacy, The University of Queensland, Brisbane QLD 4072, Australia.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Hennig
authors.affiliation: Department of Respiratory Medicine, The Children's Hospital at Westmead, Westmead, NSW 2145, Australia; Discipline of Paediatrics and Child Health, The University of Sydney, Australia.
authors.forename: Karen
authors.initials: K
authors.lastname: McKay
authors.affiliation: Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Flemington Road Parkville, Melbourne, VIC 3052, Australia; Department of Paediatrics, University of Melbourne, Australia.
authors.forename: Suzanna
authors.initials: S
authors.lastname: Vidmar
authors.affiliation: Department of Audiology, The Children's Hospital at Westmead, Westmead, NSW 2145, Australia.
authors.forename: Katie
authors.initials: K
authors.lastname: O'Brien
authors.affiliation: Queensland Children's Medical Research Institute, The University of Queensland, Brisbane, QLD 4072, Australia; Pharmacy Department, Royal Children's Hospital, Herston 4029, Australia.
authors.forename: Sonya
authors.initials: S
authors.lastname: Stacey
authors.affiliation: Queensland Children's Respiratory Centre, Royal Children's Hospital, Herston, QLD 4029, Australia; Queensland Children's Medical Research Institute, The University of Queensland, Brisbane, QLD 4072, Australia.
authors.forename: Joyce
authors.initials: J
authors.lastname: Cheney
authors.affiliation: Department of Audiology, The Children's Hospital at Westmead, Westmead, NSW 2145, Australia; Queensland Children's Medical Research Institute, The University of Queensland, Brisbane, QLD 4072, Australia.
authors.forename: Claire E
authors.initials: CE
authors.lastname: Wainwright
mesh_terms: D000280:Administration, Inhalation; D061605:Administration, Intravenous; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D002675:Child, Preschool; D003550:Cystic Fibrosis / Q000150:complications*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011552:Pseudomonas Infections / Q000150:complications / Q000188:drug therapy*; D011550:Pseudomonas aeruginosa / Q000302:isolation & purification; D012189:Retrospective Studies; D014031:Tobramycin / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D014031:Tobramycin
keywords: Adverse events; Aminoglycoside; Cystic fibrosis; Paediatrics; Tobramycin solution for inhalation