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Cited by 80Antifungal resistance and susceptibilityAntibiotics Pharmacokinetics and EfficacyFungal Infections and Studies

Concentrations in plasma and safety of 7 days of intravenous itraconazole followed by 2 weeks of oral itraconazole solution in patients in intensive care units

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Vandewoude, K, Vogelaers, D, Decruyenaere, J, Jaqmin, P, De Beule, K, Van Peer, A, Woestenborghs, R, Groen, K +1 more·1997·Antimicrobial Agents and Chemotherapy
DOI 10.1128/aac.41.12.2714PMC PMC164194
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Abstract

Pharmacokinetics and safety of a hydroxy-beta-propyl solution of itraconazole were assessed in 16 patients in an intensive care unit. On the first 2 days, four 1-h infusions of 200 mg were given at 0, 8, 24, and 32 h. From day 3 to 7, inclusive, a single 1-h infusion of 200 mg of itraconazole was given daily. The intravenous (i.v.) treatment was directly followed by repeated administrations of an oral solution of itraconazole at a dosage of either 200 mg once daily or 200 mg twice daily (b.i.d.). During i.v. treatment, steady-state concentrations of itraconazole and hydroxy-itraconazole in plasma were reached within 48 and 96 h, respectively. At the end of i.v. treatment, mean (+/- standard deviation) itraconazole and hydroxy-itraconazole trough concentrations in plasma were 0.344 +/- 0.140 and 0.605 +/- 0.205 microg/ml, respectively. After the 2-week oral follow-up of 200 mg once daily the mean trough concentration had decreased to 0.245 microg/ml, whereas after 200 mg b.i.d. it increased to 0.369 microg/ml. Diarrhea during oral treatment appeared to be dose related and may be due to the solvent hydroxypropyl-beta-cyclodextrin. More severe laboratory abnormalities were noted during the i.v. than the oral treatment phase, probably related to more severe illness in that period of intensive care, but none proved clinically important. These results suggest that plasma itraconazole levels above 0.250 microg/ml may be achieved and maintained with the 1-week i.v. schedule followed by b.i.d. oral administration, whereas the once-daily oral follow-up seems to be a suboptimal treatment.

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  • The intravenous itraconazole formulation was licensed on the basis of evidence that its dosing regimen achieves adequate blood levels more rapidly and with less patient-to-patient variability than do oral preparations of the drug.

    “and was licensed on the basis of evidence that this dosing regimen achieves adequate blood levels more rapidly and with less patient-to-patient variability than do oral preparations of the drug [41][42][43][44].”

    From Guidelines for Treatment of Candidiasis (2004) · cites this paper as [42]

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Authors
Vandewoude, K., Vogelaers, D., Decruyenaere, J., Jaqmin, P., De Beule, K., Van Peer, A., Woestenborghs, R., Groen, K., & Colardyn, F.
Affiliations
  • Ghent University Hospital (BE)
  • Department of Intensive Care, Universitair Ziekenhuis Gent, Belgium.
ORCID
Venue
Antimicrobial Agents and Chemotherapy
Publisher
American Society for Microbiology
Published
1997-12
Volume
41
Issue
12
Pages
2714-2718
ISSN
  • 0066-4804 (ISSN-L)
  • 1098-6596
DOI
10.1128/aac.41.12.2714
PMC
PMC164194
OpenAlex
W2114500604
Cited by
79
References
16
Citations by year
2024: 1 · 2023: 1 · 2022: 1 · 2021: 3 · 2019: 1 · 2017: 2 · 2016: 1 · 2015: 2 · 2014: 2 · 2013: 1
FWCI
2.93
Type
journal article
Language
en
Open access
Licence
journals.asm.org/non-commercial-tdm-license (tdm)
Locations
  • Antimicrobial Agents and Chemotherapy (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • Ghent University Academic Bibliography (Ghent University) (submittedVersion)
Topics
  • Health Sciences › Medicine › Infectious Diseases › Antifungal resistance and susceptibility
  • Health Sciences › Medicine › Pharmacology › Antibiotics Pharmacokinetics and Efficacy
  • Health Sciences › Medicine › Epidemiology › Fungal Infections and Studies
Keywords
itraconazole, pharmacokinetics, plasma drug concentration, intravenous to oral switch, intensive care unit patients, antifungal therapy, diarrhea, hydroxypropyl-β-cyclodextrin, trough concentration, dosing regimen
MeSH terms
2-Hydroxypropyl-beta-cyclodextrin, Adolescent, Adult, Antifungal Agents, Cyclodextrins, Drug Administration Schedule, Female, Humans, Infusions, Intravenous, Intensive Care Units, Male, Middle Aged, Mycoses, Solutions, Itraconazole, beta-Cyclodextrins

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