title: Evaluation of teicoplanin concentrations and safety analysis in neonates.
abstract: The aims of this study were (i) to evaluate the relationship between teicoplanin (TEIC) dosage and subsequent trough concentration, (ii) to investigate factors that affect TEIC serum concentration fluctuations and (iii) to examine the association between serum concentration of TEIC and adverse reactions in neonates. A total of 37 eligible neonates (<28 days of age) treated with TEIC from 2008-2012 were included in this study. The median trough concentration in the loading dose regimen of >12-16 mg/kg on Day 1, followed by >6-8 mg/kg every 24 h (q24 h) was 19.6 μg/mL on Day 3 or 4, and the median trough concentration in the maintenance dose regimen of >6-8 mg/kg q24 h was 18.5 μg/mL at steady-state. There were significant correlations between serum creatinine and concentration/dose (C/D) ratio (r=0.475, P=0.019), body weight and C/D ratio (r=-0.425, P=0.038) and corrected gestational age and C/D ratio (r=-0.482, P=0.017) after administering the loading dose. The incidence of hepatic dysfunction, renal impairment and thrombocytopenia was 14.8%, 20.0% and 14.8%, respectively. There was no significant difference in the incidence of adverse reactions between the trough concentration <20 μg/mL and ≥20 μg/mL groups. These data suggest that the recommended TEIC dosage for neonates is appropriate to achieve and maintain a trough concentration range of 15-30 μg/mL, and it is possible to set the target trough concentration at ≥20 μg/mL for deep-seated infections such as endocarditis, bone and joint infections, and osteomyelitis.
authors.affiliation: Department of Pharmacy, Kyushu University Hospital, Fukuoka, Japan.
authors.forename: Takaaki
authors.initials: T
authors.lastname: Yamada
authors.affiliation: Department of Pharmacy, Kyushu University Hospital, Fukuoka, Japan; Department of Clinical Pharmacy and Pharmaceutical Care, Graduate School of Pharmaceutical Sciences, Kyushu University, Fukuoka, Japan. Electronic address: t-kubota@pharm.med.kyushu-u.ac.jp.
authors.forename: Toshio
authors.initials: T
authors.lastname: Kubota
authors.affiliation: Department of Clinical Pharmacy and Pharmaceutical Care, Graduate School of Pharmaceutical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Masako
authors.initials: M
authors.lastname: Nakamura
authors.affiliation: Department of Pediatrics, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Ochiai
authors.affiliation: Department of Clinical Pharmacy and Pharmaceutical Care, Graduate School of Pharmaceutical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Mahoro
authors.initials: M
authors.lastname: Yonezawa
authors.affiliation: Department of Pharmacy, Kyushu University Hospital, Fukuoka, Japan.
authors.forename: Takahisa
authors.initials: T
authors.lastname: Yano
authors.affiliation: Department of Pharmacy, Kyushu University Hospital, Fukuoka, Japan.
authors.forename: Takehiro
authors.initials: T
authors.lastname: Kawashiri
authors.affiliation: Department of Pharmacy, Kyushu University Hospital, Fukuoka, Japan; Department of Clinical Pharmacology and Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Egashira
authors.affiliation: Department of Pediatrics, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Toshiro
authors.initials: T
authors.lastname: Hara
authors.affiliation: Department of Pharmacy, Kyushu University Hospital, Fukuoka, Japan; Department of Clinical Pharmacology and Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Satohiro
authors.initials: S
authors.lastname: Masuda
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects* / Q000493:pharmacokinetics; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D017093:Liver Failure / Q000139:chemically induced; D008297:Male; D051437:Renal Insufficiency / Q000139:chemically induced; D044967:Serum / Q000737:chemistry*; D017334:Teicoplanin / Q000008:administration & dosage* / Q000009:adverse effects* / Q000493:pharmacokinetics; D013921:Thrombocytopenia / Q000139:chemically induced
chemical_list: D000900:Anti-Bacterial Agents; D017334:Teicoplanin
keywords: Neonates; Safety analysis; Teicoplanin; Therapeutic drug monitoring