Evaluation of teicoplanin concentrations and safety analysis in neonates

Int J Antimicrob Agents. 2014 Nov;44(5):458-62. doi: 10.1016/j.ijantimicag.2014.07.005. Epub 2014 Aug 20.

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.

Keywords: Neonates; Safety analysis; Teicoplanin; Therapeutic drug monitoring.

MeSH terms

  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Bacterial Agents / adverse effects*
  • Anti-Bacterial Agents / pharmacokinetics
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Drug-Related Side Effects and Adverse Reactions / pathology
  • Female
  • Humans
  • Incidence
  • Infant, Newborn
  • Liver Failure / chemically induced
  • Male
  • Renal Insufficiency / chemically induced
  • Serum / chemistry*
  • Teicoplanin / administration & dosage*
  • Teicoplanin / adverse effects*
  • Teicoplanin / pharmacokinetics
  • Thrombocytopenia / chemically induced

Substances

  • Anti-Bacterial Agents
  • Teicoplanin