Pharmacokinetics of Posaconazole Oral Suspension in Children Dosed According to Body Surface Area.
Pediatr Infect Dis J
; 35(2): 183-8, 2016 Feb.
Article
em En
| MEDLINE
| ID: mdl-26544987
ABSTRACT
BACKGROUND:
Antifungal prophylaxis remains challenging in immunocompromised children as no clear consensus has yet been reached about which drug to be used. Posaconazole has a broad spectrum of activity, a favorable safety profile and excellent prophylactic activity in adults. However, a lack of pharmacokinetic studies in pediatric patients hampers routine implementation. This study investigates the pharmacokinetics of a newly introduced posaconazole dosing regimen based on the body surface area in pediatric hematologic patients.METHODS:
In this prospective pharmacokinetic study, 8 blood samples were taken during 1 dosing interval at steady state in children aged 13 years or younger with hematologic malignancy, who were treated prophylactically with posaconazole oral suspension at a dose of 120 mg/m 3 times daily. Posaconazole plasma concentrations were determined using high-performance liquid chromatography fluorescence detection.RESULTS:
One hundred twelve samples were taken from 14 patients with a mean age of 6.7 ± 2.8 years. A median posaconazole daily dose of 100.0 mg (77.3-100.0) 3 times daily (tid), corresponding to a median of 117.9 mg/m (112.2-120.4) tid, resulted in mean trough posaconazole plasma concentrations of 0.85 ± 0.56 mg/L. Pharmacokinetic analysis revealed a clearance of 0.8 L/(h kg) (0.5-1.4). No invasive fungal infections or adverse events were encountered during treatment.CONCLUSIONS:
Posaconazole is a promising antifungal agent to be used prophylactically in hematologic patients aged 13 years or younger. Administering posaconazole oral suspension in a dosage of 120 mg/m tid results in adequate posaconazole plasma exposure, without significant adverse events.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Suspensões
/
Triazóis
/
Antifúngicos
Tipo de estudo:
Observational_studies
/
Risk_factors_studies
Limite:
Adolescent
/
Child
/
Child, preschool
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
Pediatr Infect Dis J
Assunto da revista:
DOENCAS TRANSMISSIVEIS
/
PEDIATRIA
Ano de publicação:
2016
Tipo de documento:
Article
País de afiliação:
Bélgica