Developmental pharmacokinetics of propylene glycol in preterm and term neonates

British Journal of Clinical Pharmacology

Volumn 75, Issue 1, 2013, Pages 162-171

  De Cock, Roosmarijn F W ^a   Knibbe, Catherijne A J ^a,b   Kulo, Aida ^c,d   De Hoon, Jan ^c   Verbesselt, Rene ^c   Danhof, Meindert ^a   Allegaert, Karel ^c  

^a LEIDEN UNIVERSITY   (Netherlands)

^b ST ANTONIUS HOSPITAL   (Netherlands)

^c UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^d UNIVERSITY OF SARAJEVO   (Bosnia and Herzegovina)

Author keywords

Neonates; Population pharmacokinetics; Propylene glycol; Toxicity

Indexed keywords

PARACETAMOL; PHENOBARBITAL; PROPYLENE GLYCOL;

ALLOMETRY; ARTICLE; BIRTH WEIGHT; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; GESTATIONAL AGE; HUMAN; MAJOR CLINICAL STUDY; NEWBORN; PERINATAL PERIOD; PLASMA CONCENTRATION-TIME CURVE; PREMATURITY; PRIORITY JOURNAL;

ACETAMINOPHEN; BIRTH WEIGHT; FEMALE; GESTATIONAL AGE; HUMANS; INFANT, NEWBORN; INFANT, PREMATURE; MODELS, BIOLOGICAL; PHENOBARBITAL; PREGNANCY; PROPYLENE GLYCOL;

EID: 84871178017     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2012.04312.x     Document Type: Article

References (28)

1. Allegaert K, Vanhaesebrouck S, Kulo A, Cosaert K, Verbesselt R, Debeer A, de Hoon J. Prospective assessment of short-term propylene glycol tolerance in neonates. Arch Dis Child 2010; 95: 1054-8.
2. Zar T, Graeber C, Perazella MA. Recognition, treatment, and prevention of propylene glycol toxicity. Semin Dial 2007; 20: 217-9.
3. Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med 2009; 10: 256-9.
4. 'Inactive' ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics Committee on Drugs. Pediatrics 1997; 99: 268-78.
5. Speth PA, Vree TB, Neilen NF, de Mulder PH, Newell DR, Gore ME, de Pauw BE. Propylene glycol pharmacokinetics and effects after intravenous infusion in humans. Ther Drug Monit 1987; 9: 255-8.
6. Wilson KC, Reardon C, Theodore AC, Farber HW. Propylene glycol toxicity: a severe iatrogenic illness in ICU patients receiving IV benzodiazepines: a case series and prospective, observational pilot study. Chest 2005; 128: 1674-81.
7. CBG-MEB. Medicinal products: allergy information. Accessed September 9, 2011.
8. Yu DK, Elmquist WF, Sawchuk RJ. Pharmacokinetics of propylene glycol in humans during multiple dosing regimens. J Pharm Sci 1985; 74: 876-9.
9. Fligner CL, Jack R, Twiggs GA, Raisys VA. Hyperosmolality induced by propylene glycol. A complication of silver sulfadiazine therapy. JAMA 1985; 253: 1606-9.
10. Nahata MC. Safety of 'inert' additives or excipients in paediatric medicines. Arch Dis Child Fetal Neonatal Ed 2009; 94: F392-3.
11. European Medicines Agency (EMA). Guidelines medicinal products for human use; safety, environment and information. Accessed September 9, 2011.
12. Chicella M, Jansen P, Parthiban A, Marlowe KF, Bencsath FA, Krueger KP, Boerth R. Propylene glycol accumulation associated with continuous infusion of lorazepam in pediatric intensive care patients. Crit Care Med 2002; 30: 2752-6.
13. Glasgow AM, Boeckx RL, Miller MK, MacDonald MG, August GP, Goodman SI. Hyperosmolality in small infants due to propylene glycol. Pediatrics 1983; 72: 353-5.
14. MacDonald MG, Fletcher AB, Johnson EL, Boeckx RL, Getson PR, Miller MK. The potential toxicity to neonates of multivitamin preparations used in parenteral nutrition. JPEN J Parenter Enteral Nutr 1987; 11: 169-71.
15. Whittaker A, Currie AE, Turner MA, Field DJ, Mulla H, Pandya HC. Toxic additives in medication for preterm infants. Arch Dis Child Fetal Neonatal Ed 2009; 94: F236-40.
16. Food and Drug Administration. Drug safety communication: serious health problems seen in premature babies given Kaletra (lopinavir/ritonavir) oral solution. Accessed September 9, 2011.
17. Boxwell D, Cao K, Lewis L, Marcus K, Nikhar B. Kaletra oral solution toxicity in neonates - lopinavir, ethanol, and/or propylene glycol? 18th Conference on Retroviruses and Opportunistic Infections (2011) 2011.
18. Yaffe SJ, Aranda JV, eds. Neonatal and Pediatric Pharmacology: Therapeutic Principles in Practice, 4th edn. Philadelphia, PA: Lippincott Williams and Wilkins, Wolters Kluwer, 2010.
19. Kulo A, Allegaert K, de Hoon J, Verbesselt R. Determination of propylene glycol in low volume plasma and urine samples of neonates by LC with photodiode array detection. Chromatographia 2011; 95: 1054-8.
20. Krekels EH, van Hasselt JG, Tibboel D, Danhof M, Knibbe CA. Systematic evaluation of the descriptive and predictive performance of paediatric morphine population models. Pharm Res 2011; 28: 797-811.
21. Montgomery DC, Peck EA. Introduction to Linear Regression Analysis. New York: Wiley, 1982; 301-02.
22. Karlsson MO, Savic RM. Diagnosing model diagnostics. Clin Pharmacol Ther 2007; 82: 17-20.
23. Comets E, Brendel K, Mentre F. Computing normalised prediction distribution errors to evaluate nonlinear mixed-effect models: the npde add-on package for R. Comput Methods Programs Biomed 2008; 90: 154-66.
24. Brendel K, Comets E, Laffont C, Laveille C, Mentre F. Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide. Pharm Res 2006; 23: 2036-49.
25. Yahwak JA, Riker RR, Fraser GL, Subak-Sharpe S. Determination of a lorazepam dose threshold for using the osmol gap to monitor for propylene glycol toxicity. Pharmacotherapy 2008; 28: 984-91.
26. Feldman W, Drummond KN. Serum and urine osmolality in normal full-term infants. Can Med Assoc J 1969; 101: 73-4.
27. Giacoia GP, Miranda R, West KI. Measured vs calculated plasma osmolality in infants with very low birth weights. Am J Dis Child 1992; 146: 712-7.
28. De Cock RF, Allegaert K, Schreuder MF, Sherwin CM, de Hoog M, van den Anker JN, Danhof M, Knibbe CA. Maturation of the glomerular filtration rate in neonates, as reflected by amikacin clearance. Clin Pharmacokinet 2012; 51: 105-17.