Safety of inhaled (TOBI(R)) and intravenous tobramycin in young children with cystic fibrosis

Hennig, Stefanie, McKay, Karen, Vidmar, Suzanna, O'Brien, Katie, Stacey, Sonya, Cheney, Joyce and Wainwright, Claire E. (2014) Safety of inhaled (TOBI(R)) and intravenous tobramycin in young children with cystic fibrosis. Journal of Cystic Fibrosis, 13 4: 428-434. doi:10.1016/j.jcf.2014.01.014

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Author Hennig, Stefanie
McKay, Karen
Vidmar, Suzanna
O'Brien, Katie
Stacey, Sonya
Cheney, Joyce
Wainwright, Claire E.
Title Safety of inhaled (TOBI(R)) and intravenous tobramycin in young children with cystic fibrosis
Formatted title
Safety of inhaled (TOBI®) and intravenous tobramycin in young children with cystic fibrosis
Journal name Journal of Cystic Fibrosis   Check publisher's open access policy
ISSN 1569-1993
1873-5010
Publication date 2014-02-22
Year available 2014
Sub-type Article (original research)
DOI 10.1016/j.jcf.2014.01.014
Open Access Status DOI
Volume 13
Issue 4
Start page 428
End page 434
Total pages 7
Place of publication Amsterdam, Netherlands
Publisher Elsevier
Language eng
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.
Formatted 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.
Keyword Aminoglycoside
Tobramycin solution for inhalation
Paediatrics
Cystic fibrosis
Adverse events
Q-Index Code C1
Q-Index Status Confirmed Code
Grant ID 9937868
Institutional Status UQ
Additional Notes Available online 22 February 2014

 
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Created: Tue, 28 Jan 2014, 17:48:13 EST by Dr Stefanie Hennig on behalf of School of Pharmacy