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- Title
Ganciclovir Population Pharmacokinetics in Neonates Following Intravenous Administration of Ganciclovir and Oral Administration of a Liquid Valganciclovir Formulation.
- Authors
Acosta, E. P.; Brundage, R. C.; King, J. R.; Sánchez, P. J.; Sood, S.; Agrawal, V.; Homans, J.; Jacobs, R. F.; Lang, D.; Romero, J. R.; Griffin, J.; Cloud, G.; Whitley, R.; Kimberlin, D. W.
- Abstract
Cytomegalovirus (CMV) is the most common viral congenital infection, producing both sensorineural hearing loss and mental retardation. Our objective was to assess the population pharmacokinetics of a research-grade oral valganciclovir solution in neonates with symptomatic congenital CMV disease. Twenty-four neonates received 6 weeks of antiviral therapy. Ganciclovir and valganciclovir were measured by liquid chromatography/tandem mass spectroscopy. NONMEM version VI beta was used for population analyses. All profiles were consistent with a one-compartment model. Postnatal age, body surface area, and gender did not improve the model fit after body weight was taken into account. The typical value of clearance (l/h), distribution volume (l), and bioavailability of ganciclovir were 0.146 × body weight (WT)1.68, 1.15 × WT, and 53.6%, respectively. Although these results cannot be extrapolated to extemporaneously compounded valganciclovir preparations, they provide the foundation on which a commercial-grade valganciclovir oral solution may be a viable option for administration to neonates.Clinical Pharmacology & Therapeutics (2007) 81, 867–872. doi:10.1038/sj.clpt.6100150; published online 28 March 2007
- Subjects
CYTOMEGALOVIRUSES; INTELLECTUAL disabilities; THERAPEUTICS; PHARMACOLOGY; CLINICAL medicine
- Publication
Clinical Pharmacology & Therapeutics, 2007, Vol 81, Issue 6, p867
- ISSN
0009-9236
- Publication type
Article
- DOI
10.1038/sj.clpt.6100150