Titre du document / Document title

Pharmacokinetics of intravenously administered azithromycin in pediatric patients

Auteur(s) / Author(s)

JACOBS Richard F. ^{(1 2)} ; MAPLES Holly D. ^{(1 2)} ; ARANDA Jacob V. ^{(2 3)} ; ESPINOZA Gabriela M. ⁽⁴⁾ ; KNIRSCH Charles ⁽⁴⁾ ; CHANDRA Richa ⁽⁵⁾ ; FISHER Jeannine M. ⁽⁵⁾ ; KEARNS Gregory L. ^{(2 6)} ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Arkansas Children's Hospital, Little Rock, AR, ETATS-UNIS
⁽²⁾ Pediatric Pharmacology Research Unit Network, National Institute of Child Health and Human Disease, Bethesda, MD, ETATS-UNIS
⁽³⁾ Children's Hospital of Michigan, Detroit, MI, ETATS-UNIS
⁽⁴⁾ Pfizer, Inc., New York, NY, ETATS-UNIS
⁽⁵⁾ Groton Laboratories, Pfizer, Inc., Groton, CT, ETATS-UNIS
⁽⁶⁾ Children's Mercy Hospitals and Clinics, Kansas City, MO, ETATS-UNIS

Résumé / Abstract

Background: The objective of this study was to characterize the pharmacokinetics and tolerance of a single intravenous (IV) azithromycin dose in children. Methods: Subjects were stratified into 4 age groups: 0.5-2 years; >2-<6 years; 6-<12 years; and 12-<16 years. Each subject received a single 10 mg/kg dose (500 mg maximum) infused in 1 hour. Serial venous blood samples were obtained for a 168-hour period, and laboratory safety evaluations were performed immediately preceding azithromycin administration and at the conclusion of the study. Serum azithromycin concentrations were quantified with a validated high performance liquid chromatography method with mass spectrometric detection. Pharmacokinetic indices were calculated for each subject by noncompartmental techniques. Results: Thirty-two subjects (6.7 ± 5.0 years, 11 boys) participated. Mean serum concentration-time data were comparable for the 4 age groups. For all subjects with evaluable data, the mean area under the curve from 0 to 72 hours (AUC_0-72) was 8.2 μg.h/mL (n = 26), the maximum concentration (C_max) was 2.4 μg/mL and the elimination half-life (t_1/2) was 65.2 hours (n = 25). The AUC_0-72 and C_max were not associated with age. The dose was well-tolerated with no serious adverse events. Conclusion: The disposition of azithromycin after a single 10-mg/kg IV dose (maximum labeled adult dose of 500 mg) is comparable in pediatric patients between 0.5 and 16 years of age. These pharmacokinetic data can be used to guide dose selection for future therapeutic trials of IV azithromycin in pediatric patients.

Revue / Journal Title

The Pediatric infectious disease journal   ISSN 0891-3668   CODEN PIDJEV 

Source / Source

2005, vol. 24, n^o1, pp. 34-39 [6 page(s) (article)] (24 ref.)

Langue / Language

Anglais

Editeur / Publisher

Lippincott, Hagerstown, MD, ETATS-UNIS  (1987) (Revue)

Mots-clés anglais / English Keywords

Macrolide ; Human ; Antibiotic ; Antibacterial agent ; Pediatrics ; Child ; Intravenous administration ; Pharmacokinetics ; Azithromycin ; Infection ;

Mots-clés français / French Keywords

Macrolide ; Homme ; Antibiotique ; Antibactérien ; Pédiatrie ; Enfant ; Voie intraveineuse ; Pharmacocinétique ; Azithromycine ; Infection ;

Mots-clés espagnols / Spanish Keywords

Macrólido ; Hombre ; Antibiótico ; Antibacteriano ; Pediatría ; Niño ; Vía intravenosa ; Farmacocinética ; Azitromicina ; Infección ;

Mots-clés d'auteur / Author Keywords

azithromycin ; pharmacokinetics ; children ;

Localisation / Location

INIST-CNRS, Cote INIST : 20356, 35400012660586.0060