Pharmacokinetics, outcome of treatment, and toxic effects of amphotericin B and 5-fluorocytosine in neonates
Abstract
To determine the pharmacokinetics of amphotericin B and 5-fluorocytosine in neonates, we measured serum concentrations at first dose and after 5 days of therapy by high-performance liquid chromatography in 13 neonates (mean birth weight 1.2 +/- 0.8 kg). The dose of amphotericin B was serially increased from 0.1 to 0.5 mg/kg/day in 10 infants but was decreased from 0.8 to 1.0 to 0.5 mg/kg/day in three infants. Amphotericin B concentrations were not detectable in infants receiving 0.1 mg/kg/day. Amphotericin B cerebrospinal fluid concentrations were 40% to 90% of serum values obtained simultaneously. Serum concentrations after oral administration of 5-fluorocytosine (dose 25 to 100 mg/kg/day) were detectable in all infants. We found extreme interindividual variability for the half-life, volume of distribution, and clearance for both drugs. Four infants had minimal elimination for both drugs between doses, a finding that correlates with rises in serum creatinine (greater than 0.4 mg/dl, 40 mumol/L) and blood urea nitrogen (greater than 10 mg/dl, 3.6 mmol/L). We recommend that the dose of amphotericin B given on the first day of treatment be greater than the usual testing dose of 0.1 mg/kg/day. We also recommend an initial 24-hour dosing interval for amphotericin B and 5-fluorocytosine. Serum drug concentrations may need to be monitored in high-risk, low birth weight infants.
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Because clearance of flucytosine is directly proportional to glomerular filtration rate, infants with very low birth weight may accumulate high plasma concentrations because of immature renal function.
“Because clearance of flucytosine is directly proportional to glomerular filtration rate, infants with very low birth weight may accumulate high plasma concentrations because of immature renal function [88].”
From Guidelines for Treatment of Candidiasis (2004) · cites this paper as [88]
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- Authors
- Baley, J. E., Meyers, C., Kliegman, R. M., Jacobs, M. R., & Blumer, J. L.
- Affiliations
- Rainbow Babies & Children's Hospital (US)
- Corresponding author
- Baley, Jill E.
- ORCID
- Jacobs, Michael R.
- Venue
- The Journal of Pediatrics
- Publisher
- Elsevier BV
- Published
- 1990-05
- Volume
- 116
- Issue
- 5
- Pages
- 791-797
- ISSN
- 0022-3476 (ISSN-L)
- OpenAlex
- W2019367173
- Cited by
- 184
- References
- 25
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 4 · 2023: 1 · 2022: 2 · 2021: 1 · 2020: 8 · 2019: 3 · 2018: 5 · 2017: 4 · 2016: 3 · 2015: 8 · 2014: 12 · 2013: 12 · 2012: 8
- FWCI
- 2.16
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Pediatrics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Antifungal resistance and susceptibility
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Health Sciences › Medicine › Epidemiology › Fungal Infections and Studies
- Keywords
- amphotericin B, 5-fluorocytosine, neonates, pharmacokinetics, serum drug concentration, cerebrospinal fluid drug concentration, interindividual variability, drug elimination, renal function, low birth weight infants, antifungal therapy, dosing interval, therapeutic drug monitoring
- MeSH terms
- Amphotericin B, Candidiasis, Flucytosine, Gestational Age, Humans, Infant, Low Birth Weight, Infant, Newborn, Infant, Premature, Kidney, Mycoses, Prognosis
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