Document Detail


Ganciclovir population pharmacokinetics in neonates following intravenous administration of ganciclovir and oral administration of a liquid valganciclovir formulation.
MedLine Citation:
PMID:  17392728     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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 x body weight (WT)(1.68), 1.15 x 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.
Authors:
E P Acosta; R C Brundage; J R King; P J Sánchez; S Sood; V Agrawal; J Homans; R F Jacobs; D Lang; J R Romero; J Griffin; G Cloud; R Whitley; D W Kimberlin;
Related Documents :
6750008 - Serology of chlamydia trachomatis in infants.
6318288 - Group b coxsackievirus infections in infants younger than three months of age: a seriou...
1671878 - A hospital-based prospective study of perinatal infection with human immunodeficiency v...
169688 - Nosocomial and maternally acquired herpesvirus hominis infections. a report of four fat...
9252078 - Transmission of gbv-c/hgv from drug-addicted mothers to their babies.
17142518 - Preventable newborn readmissions since passage of the newborns' and mothers' health pro...
Publication Detail:
Type:  Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2007-03-28
Journal Detail:
Title:  Clinical pharmacology and therapeutics     Volume:  81     ISSN:  0009-9236     ISO Abbreviation:  Clin. Pharmacol. Ther.     Publication Date:  2007 Jun 
Date Detail:
Created Date:  2007-05-16     Completed Date:  2007-07-27     Revised Date:  2014-04-08    
Medline Journal Info:
Nlm Unique ID:  0372741     Medline TA:  Clin Pharmacol Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  867-72     Citation Subset:  AIM; IM    
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Antiviral Agents / blood,  pharmacokinetics*,  therapeutic use
Area Under Curve
Body Weight
Chromatography, High Pressure Liquid
Cytomegalovirus Infections / drug therapy*
Female
Ganciclovir / analogs & derivatives*,  blood,  pharmacokinetics*,  therapeutic use
Humans
Infant
Infant, Newborn
Infant, Newborn, Diseases / drug therapy
Injections, Intravenous
Male
Tandem Mass Spectrometry
Grant Support
ID/Acronym/Agency:
M01-RR00032/RR/NCRR NIH HHS; N01-AI-15113/AI/NIAID NIH HHS; N01-AI-30025/AI/NIAID NIH HHS; N01-AI-62554/AI/NIAID NIH HHS; N01-AI-65306/AI/NIAID NIH HHS
Chemical
Reg. No./Substance:
0/Antiviral Agents; 0/valganciclovir; P9G3CKZ4P5/Ganciclovir

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  Developing strategies to link basic cardiovascular sciences with clinical drug development: another ...
Next Document:  Effects of daily ingestion of cranberry juice on the pharmacokinetics of warfarin, tizanidine, and m...