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Study of Preterm Infants with Different Gestational Age: Modifying Amikacin Sulphate Dosage Regimen

Authors: Chauhan, Bindiya; Jalalpure, Sunil S;

Study of Preterm Infants with Different Gestational Age: Modifying Amikacin Sulphate Dosage Regimen

Abstract

{"references": ["1. Sook HA, et al. Outcomes of a new dosage regimen of amikacin based on pharmacokinetic parameters of korean neonates. Am J Health-Syst Pharm. 2014;71:122-127.", "2. Engler D, et al. Use of amikacin in neonates and related ototoxicity. Prof Nurs Today. 2013;17(1):24-28.", "3. Cynthia FK, et al. Amikacin pharmacokinetics and suggested dosage modifications for the preterm infant. Anitmicrob Agents Chemother. 1990;34:265-268.", "4. Daniel JT, et al.Therapeutic drug monitoring of a m i n o g l y c o s i d e s i n n e o n a t e s . C l i n Pharmacokinet. 2009;48(2):71-88.", "5. Alison K, et al.Aminoglycoside toxicity in neonates: something to worry about? Expert Rev Anti Infect Ther. 2014;12(3):319\u2013331.", "6. Thomas EY. Therapeutic drug monitoring - the appropriate use of drug level measurement in the care of the neonate. Clin Perinatol. 2012;39:25- 31.", "7. Cathrine MTS, et al.Individualised dosing of amikacin in neonates: a pharmacokinetic/ pharmacodynamic analysis. Eur J Clin Pharmacol. 2009;65(7):705-713.", "8. Emanuele DM, et al. Do we still need the aminoglycosides? Int J Antimicrob Agents. . 2009;33:201-205.", "9. Johannes NA, Karel A. Pharmacokinetics of aminoglycosides in the newborn. Curr Pharm Des. 2012;18:3114-3118.", "10. Bartal C, et al. Pharmacokinetic dosing of aminoglycosides: a controlled trial. Am J Med. 2003;114(3):194-198.", "11. Siddiqi A, et al. Therapeutic drug monitoring of amikacin in preterm and term infants. Singapore Med J. 2009;50(5):486-489.", "12. Janko S, et al.Neonatal medicines research: challenges and opportunities. Expert Opin Drug Metab Toxicol. 2015;11(7):1041-1052.", "13. Karel A, John NA. Clinical pharmacology in neonates: small size, huge variability. Neonatology. 2014;105:344\u2013349.", "14. Reza M. Confounding issues in estimation of patient-specific pharmacokinetic parameters and dosage individualization of aminoglycosides. Curr Clin Pharmacol. 2012;7:28-35.", "15. Lesko LJ, Schmidt S. Individulization of drug therapy: history, present state, and opportunities for the future. Clin Pharmacol Ther. 2012;92(4):458-466.", "16. Gian MP. Clinical pharmacokinetics of aminoglycosides in the neonate: a review. Eur J Clin Pharmacol. 2009;65:419\u2013427.", "17. Ramon CM, et al. The Amikacin on premature newborn: schema of treatment defined by gestational and postnatal age. Rev Biomed. 2000;11:251-256.", "18. Waele JJD, Neve ND. Aminoglycosides for lifethreatening infections: a plea for an individualized approach using intensive therapeutic drug monitoring. Minerva Anestesiol. 2014;80(10):1135-1142.", "19. Chauhan B, Jalalpure S. Analysis of amikacin in human serum by UHPLC with fluorescence detector using chloro-formate reagent with glycine. Pharm Methods. 2016;7(2):99-103.", "20. Bateman DA, et al. Serum creatinine concentration in very-low-birth-weight infants from birth to 34\u201336 wk postmenstrual age. Pediatr Res. 2015;77(5):696-702.", "21. Karel A, et al. Limited predictability of amikacin clearance in extreme premature neonates at birth. Br J Clin Pharmacol. 2015;61:39\u201348.", "22. Venisse N, Boulamery A. Level of evidence for therapeutic drug monitoring of aminoglycosides. Therapie. 2011;66(1):39-44.", "23. Mark AT. Neonatal drug development. Early Hum Dev. 2011;87:763-768.", "24. Justin LS, Robert M. Newborns, one of the last therapeutic orphans to be adopted. JAMA Pediatr. 2014;168:106-108.", "25. Karel A. Tailored tools to improve pharmacotherapy in infants. Expert Opin Drug Metab Toxicol. 2014;10(8):1069-1078.", "26. Laughon MM, et al. Drug Labeling and Exposure in Neonates. JAMA Pediatr. 2014;168(2):130- 136."]}

The study was performed to determine the gestational age of preterm infants that requires amikacin therapeutic drug monitoring. A study was conducted in preterm infants on amikacin therapy with gestational age of 28 to 36 weeks. Therapeutic drug monitoring in preterm infants was performed based on their individual pharmacokinetics to avoid ototoxicity and nephrotoxicity. Its prerequisite, because of their immuno-compromised and challenging clinical conditions, to provide an effective and optimized dosage regimen. One compartment model was used to calculate pharmacokinetics and modulated amikacin dosage regimen based on obtained amikacin peak and trough concentration at 3rd dose. Amikacin inadequate level, especially high trough found in 60 % patients were optimized for therapeutic level by tailoring dosage regimen. Correlation between percentage modification of dose and dosing time interval with percentage changes of amikacin peak and trough concentration at modulated dose was studied.

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Keywords

dosing time interval, modulated dose, therapeutic drug monitoring (TDM), amikacin, preterm infants, pharmacokinetic

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