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Pharmacokinetics of fluconazole in very low birth weight infants during the first two weeks of life
Abstract
OBJECTIVE: To find a dose of fluconazole for very low birth weight infants during an outbreak of Candida parapsilosis. METHODS: Twelve premature infants (mean gestational age, 27.4 weeks; mean birth weight, 912 gm) receiving fluconazole prophylactically from the first day of life were enrolled in an open phase I-II pharmacokinetics, safety, and tolerance trial. Up to 5 doses of 6 mg/kg were administered intravenously every 72 hours during the first 2 weeks of life. Pharmacokinetic characteristics of fluconazole were determined after the first, third, and fifth doses. RESULTS: The mean peak and trough concentrations after the 3 doses were 5.5 and 2.6 micrograms/ml, 12.8 and 4.3 micrograms/ml, and 10.0 and 2.9 micrograms/ml (p = 0.0002 and p = 0.07), respectively. The mean fluconazole half-lives were 88.6 hours (n = 7), 67.5 hours (n = 9), and 55.2 hours (n = 4; p = 0.3). The mean total clearance corrected for weight (CL/kg) was 0.18 ml/min/kg (n = 7), 0.33 ml/min/kg (n = 7), and 0.52 ml/min/kg (n = 4; p = 0.02), and the mean volume of distribution 1.18 L/kg (n = 7), 1.84 L/kg (n = 7), and 2.25 L/kg (n = 4; p = 0.05). Weight-corrected clearance increased with postnatal age (r = 0.61; p = 0.007). CONCLUSIONS: With the used fluconazole dose (6 mg/kg every 3 days), the mean serum peak and trough concentrations increased during the first week but decreased during the second week. After the first week we suggest a dose of 6 mg/kg every 2 days, or even daily.
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“The pharmacokinetics of fluconazole vary with age [89][90][91][92].”
From Guidelines for Treatment of Candidiasis (2004) · cites this paper as [91]
In the citing paper
“the pharmacological properties of fluconazole vary with neonatal age, making the choice of dosage somewhat difficult [86,90,91].”
From Guidelines for Treatment of Candidiasis (2004) · cites this paper as [91]
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Pappas, P. G., Kauffman, C. A., Andes, D. R., Clancy, C. J., Marr, K. A., Ostrosky-Zeichner, L., Reboli, A. C., Schuster, M. G., Vazquez, J. A., Walsh, T. J., et al. (2016) · Clinical Infectious Diseases · doi:10.1093/cid/civ933 · Cited by 4,200
“Thus, a daily fluconazole dose of 12 mg/kg is necessary for neonates and children [102–105].”
BackgroundPappas, P. G., Kauffman, C. A., Andes, D., Benjamin, D. K., Calandra, T. F., Edwards, J. E., Filler, S. G., Fisher, J. F., Kullberg, B.-J., Zeichner, L. O., et al. (2009) · Clinical Infectious Diseases · doi:10.1086/596757 · Cited by 3,191
“of distribution and longer half-life [63, 64]; it has been recently”
BackgroundGuidelines for Treatment of Candidiasis
Pappas, P. G., Rex, J. H., Sobel, J. D., Filler, S. G., Dismukes, W. E., Walsh, T. J., & Edwards, J. E. (2004) · Clinical Infectious Diseases · doi:10.1086/380796 · Cited by 1,440
“In particular, the pharmacological properties of fluconazole vary with neonatal age, making the choice of dosage somewhat difficult [86, 90, 91].”
BackgroundPractice Guidelines for the Treatment of Candidiasis
Rex, J. H., Walsh, T. J., Sobel, J. D., Filler, S. G., Pappas, P. G., Dismukes, W. E., & Edwards, J. E. (2000) · Clinical Infectious Diseases · doi:10.1086/313749 · Cited by 927
“In particular, the pharmacology of fluconazole varies with neonatal age, making rational dosing somewhat difficult [31, 35, 36].”
BackgroundFluconazole prophylaxis against fungal colonization and infection in preterm infants.
Kaufman, D., Boyle, R., Hazen, K. C., Patrie, J. T., Robinson, M., & Donowitz, L. G. (2001) · New England Journal of Medicine · doi:10.1056/nejmoa010494 · Cited by 523
Metadata
- Authors
- Saxén, H., Hoppu, K., & Pohjavuori, M.
- Affiliations
- University of Helsinki (FI)
- Corresponding author
- Hoppu, Kalle
- ORCID
- Hoppu, Kalle
- Venue
- Clinical Pharmacology and Therapeutics
- Publisher
- Wiley
- Published
- 1993
- Volume
- 54
- Issue
- 3
- Pages
- 269-277
- ISSN
- 0009-9236 (ISSN-L)
- 1532-6535
- OpenAlex
- W1969659982
- Cited by
- 127
- References
- 0
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 1 · 2022: 1 · 2021: 5 · 2020: 4 · 2019: 4 · 2018: 1 · 2017: 3 · 2016: 6 · 2015: 3 · 2014: 6 · 2013: 6 · 2012: 4
- FWCI
- 2.72
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Pharmacology & Therapeutics (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 › Pharmacology (medical) › Antibiotics Pharmacokinetics and Efficacy
- Keywords
- fluconazole, pharmacokinetics, very low birth weight infants, preterm infants, Candida parapsilosis, antifungal prophylaxis, intravenous administration, drug clearance, volume of distribution, half-life, postnatal age
- MeSH terms
- Candidiasis, Female, Half-Life, Humans, Infant, Low Birth Weight, Infant, Newborn, Infant, Premature, Infant, Premature, Diseases, Male, Pilot Projects, Fluconazole
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