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A Retrospective Analysis of Vancomycin Pharmacokinetics in Korean Neonates
J. Kor. Soc. Health-syst. Pharm. 2019;36:201-211
Published online May 31, 2019;  https://doi.org/10.32429/jkshp.2019.36.2.003
© 2019 Korean Society of Health-System Pharmacists

Hyun Jung Shina, Hye Jung Baea,†, Moon Jin Kima, Ae Hee Junga, Sun Hoi Junga, Hyeon Joo Hahna, Yun Hee Joa, Yoon Sook Choa and Seung Han Shinb

Department of Pharmacya, Department of Pediatricsb, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Koreaa,b
Correspondence to: 배혜정 Tel:02-2072-3420 E-mail:baehj021004@hanmail.net
Received January 28, 2019; Revised February 13, 2019; Accepted March 15, 2019.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background : Vancomycin is commonly used in neonatal intensive care units (NICU) for the treatment of gram-positive bacterial infections. The aims of this study were to determine the pharmacokinetic parameters of vancomycin in Korean neonates and to assess the percentage of neonates who reached a therapeutic level (trough concentrations of 10 to 20 mg/L) with empirical vancomycin dosing according to the Neofax®.
Methods : This retrospective study reviewed data from 81 neonates admitted to the NICU. The elimination rate constant (Ke), half-life (T1/2), clearance (CL), and the extrapolated trough and peak levels were calculated using first-order pharmacokinetics and a one-compartment model.
Results : Only 21% of the patients achieved therapeutic trough levels (10 to 20 mg/L) with initial dosing according to the Neofax®. Vancomycin clearance was significantly correlated with postmenstrual age (PMA), postnatal age (PNA), weight, and serum creatinine (SCr) level. The recommended dosing regimen in neonates <27 weeks PMA was 10~15 mg/kg q12hr. For neonates in the 27 to 30 week PMA range, the recommended regimen was 15 mg/kg q12hr or 10 mg/kg q8hr for PNA 0~14 days, 10~13 mg/kg q8hr for PNA >14 days with SCr <0.6 mg/dL, and 10~15 mg/kg q12hr for PNA >14 days with SCr 0.6 to <1.5 mg/dL. For neonates in the 30 to 37 week PMA range, the recommended regimen was 10~13 mg/kg q8hr for PNA 0~14 days, 13 mg/kg q8hr or 10 mg/kg q6hr for PNA >14 days with SCr <0.6 mg/dL, and 15 mg/kg q12hr or 10 mg/kg q8hr for PNA >14 days with SCr 0.6 to <1.5 mg/dL. For neonates in the 37 to 44 week PMA range, the recommended regimen was 10~13 mg/kg q8hr for PNA 0~7 days, 13~15 mg/kg q6hr for PNA >7 days with SCr <0.6 mg/dL, and 13 mg/kg q8hr or 10 mg/kg q6hr for PNA >7 days with SCr 0.6 to <1.5 mg/dL. Sixty-three percent (51/81) of the neonates reached a therapeutic level with the new dosing regimen.
Conclusions : The Neofax® vancomycin initial dosing regimen is insufficient for Korean neonates. Further studies are needed to validate the new dosing regimen suitable for achieving target therapeutic levels in Korean neonates.
Keywords : Vancomycin, Infant, Newborn, Pharmacokinetics