The pharmacokinetics and toxicity of once-daily tobramycin therapy in children with cystic fibrosis

Bragonier, R.; Brown, Nesbitt D.

doi:10.1093/jac/42.1.103

Cited by 41 publications

(43 citation statements)

References 9 publications

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“…Four studies reported at least one episode of ototoxicity, with a frequency of 8-14%. 45,49,53,55 In one study the side effect was not clinically significant55; the other three studies did not comment on clinical significance. 45,49,53 The overall frequency of ototoxicity in the eight studies was 3.5% (9/254), with it occurring in 4.1% (7/171) and 2.4% (2/83) of patients treated with ODD and traditional regimen, respectively.…”

Section: Ototoxicitymentioning

confidence: 94%

“…6,11,[44][45][46][47][48][49][50][51][52][53][54][55][56] This regimen also was investigated in neonates up to 1 month of age but is not discussed here due to the decreased renal function in that patient population. Infectious processes included neutropenic fever, suspected or confirmed gramnegative infections, cystic fibrosis, and suspected or confirmed surgical infections.…”

Section: Efficacy In Childrenmentioning

confidence: 99%

“…44,45,[47][48][49][50][51][52][53][54][55] Most of them defined nephrotoxicity as a percentage increase in serum creatinine concentration over baseline or a percentage decrease in creatinine clearance from baseline. In addition to creatinine clearance monitoring, 24-hour proteinuria, lysozymuria, and B2 microglobulinuria were measured to determine nephrotoxicity.…”

Section: Nephrotoxicitymentioning

confidence: 99%

“…44,45,48,49,[52][53][54][55] Overall, 57% (171/300) and 56% (83/147) of patients receiving ODD and traditionally dosed aminoglycosides, respectively, were assessed with an audiometric examination. Four studies reported at least one episode of ototoxicity, with a frequency of 8-14%.…”

Section: Ototoxicitymentioning

confidence: 99%

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Clinical Issues Surrounding Once‐Daily Aminoglycoside Dosing in Children

2003

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Aminoglycoside antibiotics are first‐line treatment for many infectious diseases in the pediatric population and are effective in adults. The traditional dosing interval in children is every 8–12 hours. Studies in adults reported equivalent efficacy and equal or less toxicity with once‐daily regimens. Despite many studies in the adult population, this approach has yet to become standard practice in most pediatric hospitals. Reasons for lack of acceptance of this strategy in children include rapid aminoglycoside clearance, unknown duration of postantibiotic effect, safety concerns, and limited clinical and efficacy data.

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Section: Ototoxicitymentioning

confidence: 94%

Section: Efficacy In Childrenmentioning

confidence: 99%

Section: Nephrotoxicitymentioning

confidence: 99%

Section: Ototoxicitymentioning

confidence: 99%

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Clinical Issues Surrounding Once‐Daily Aminoglycoside Dosing in Children

2003

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“…day -1 of tobramycin [102] and netilmicin [120] has been associated with symptoms of dizziness after the antibiotic infusion. However, surprisingly few side-effects have been reported in high dose aminoglycoside therapy [89,121,122]. Nevertheless, it is necessary to monitor ototoxicity and renal function and adjust the dosage interval accordingly, early in therapy [64].…”

Section: Intravenous Antipseudomonal Antibiotic Therapy In Cystic Fibmentioning

confidence: 99%

Antibiotic therapy against Pseudomonas aeruginosa in cystic fibrosis: a European consensus

Döring¹,

Conway²,

Heijerman³

et al. 2000

Eur Respir J

559

478

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Cystic fibrosis (CF) is the most common lethal hereditary disorder with autosomal recessive heredity in caucasians. The majority of CF patients suffer from chronic respiratory infection with the opportunistic bacterial pathogen Pseudomonas aeruginosa. No consensus among clinicians has been reached so far concerning antibiotic treatment against P. aeruginosa in CF patients.Consensus answers to 24 important questions in this context, based on current evidence, are presented, given by a panel of 34 European experts. Questions addressed and answered are: The diagnosis of P. aeruginosa lung colonization in CF; The impact of P. aeruginosa on the clinical state of CF patients; The assessment of P. aeruginosa susceptibility against antibiotics and the importance of these results for the clinician; The use of monotherapy versus combination therapy; The development of microbial resistance; The achievement of optimal airway concentrations; The effects of subinhibitory concentrations of antibiotics on P. aeruginosa; Statements on the pharmacokinetics of antibiotics in CF patients; Recommendations for doses and dosing intervals and length of treatment regimens; and Toxic side effects due to repeated antibiotic therapy was addressed.The expert panel answered further questions on the use of fluoroquinolones in children with CF, on the administration of nebulized antibiotics and whether prevention of P. aeruginosa lung colonization is possible in CF using antibiotic therapy.Problems of antibiotic therapy at home and in the hospital were addressed, a consensus statement on regular maintenance treatment, or treatment on demand, was given and different routes of administration of antibiotics were recommended for different clinical situations.Finally, the factors which determine the choice of the antibiotic, the dosage, and the duration of the treatment in cystic fibrosis patients were addressed and the design of future antibiotic studies in the context of Pseudomonas aeruginosa lung infection in cystic fibrosis patients were recommended. Eur Respir J 2000; 16: 749±767.

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Optimization of anti‐pseudomonal antibiotics for cystic fibrosis pulmonary exacerbations: V. Aminoglycosides

Young

Zobell

Stockmann

et al. 2013

Pediatric Pulmonology

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Intravenous (IV) anti-pseudomonal aminoglycosides (i.e., amikacin and tobramycin) have been shown to be tolerable and effective in the treatment of acute pulmonary exacerbations (APEs) in both pediatric and adult patients with cystic fibrosis. The aim of this review is to provide an evidence-based summary of pharmacokinetic/pharmacodynamic, tolerability, and efficacy studies utilizing IV amikacin, gentamicin, and tobramycin in the treatment of APE and to highlight areas where further investigation is needed. The Cystic Fibrosis Foundation Pulmonary Guidelines recommend that once-daily administration of aminoglycosides is preferred over three times per day in the treatment of an APE. The literature supports dosing ranges for amikacin and tobramycin of 30-35 and 7-15 mg/kg/day, respectively, given once daily, with subsequent doses determined by therapeutic drug concentration monitoring. The literature does not support the routine use of gentamicin in the treatment of APE due to a lack of studies showing efficacy and evidence indicating an increased risk of nephrotoxicity. Further studies are needed to determine the optimal dosing strategy of amikacin in the treatment of an APE, and to further identify risk factors and determinants that influence the development of P. aeruginosa resistance with once-daily administration of tobramycin.

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The pharmacokinetics and toxicity of once-daily tobramycin therapy in children with cystic fibrosis

Cited by 41 publications

References 9 publications

Clinical Issues Surrounding Once‐Daily Aminoglycoside Dosing in Children

Clinical Issues Surrounding Once‐Daily Aminoglycoside Dosing in Children

Antibiotic therapy against Pseudomonas aeruginosa in cystic fibrosis: a European consensus

Optimization of anti‐pseudomonal antibiotics for cystic fibrosis pulmonary exacerbations: V. Aminoglycosides

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