Clonidine clearance matures rapidly during the early postnatal period: A population pharmacokinetic analysis in newborns with neonatal abstinence syndrome

Journal of Clinical Pharmacology

Volumn 51, Issue 4, 2011, Pages 502-511

  Xie, Hong Guang ^a,b   Cao, Ying Jun ^c   Gauda, Estelle B ^d   Agthe, Alexander G ^e   Hendrix, Craig W ^c   Lee, Howard ^a,b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b Washington Virginia Medical Center   (United States)

^c JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d DEPARTMENT OF PATHOLOGY   (United States)

^e UNIVERSITY OF MARYLAND MEDICAL CENTER   (United States)

Author keywords

Clonidine; Modeling; Neonatal abstinence syndrome; Neonate; Pediatrics; Population pharmacokinetics; Renal clearance

Indexed keywords

CLONIDINE; PLACEBO;

ARTICLE; BODY WEIGHT; CLINICAL ARTICLE; COMPARTMENT MODEL; COMPUTER MODEL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; GROUPS BY AGE; HUMAN; NEWBORN; PERINATAL PERIOD; POPULATION MODEL; RANDOMIZED CONTROLLED TRIAL; WITHDRAWAL SYNDROME;

ADMINISTRATION, ORAL; ADRENERGIC ALPHA-2 RECEPTOR AGONISTS; CLONIDINE; DOUBLE-BLIND METHOD; HUMANS; INFANT, NEWBORN; METABOLIC CLEARANCE RATE; MODELS, BIOLOGICAL; NEONATAL ABSTINENCE SYNDROME; PLACEBOS; PROSPECTIVE STUDIES;

EID: 79953790529     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270010370587     Document Type: Article

References (48)

1. Potts AL, Larsson P, Eksborg S, Warman G, Lonnqvist PA, Anderson BJ. Clonidine disposition in children; a population analysis. Paediatr Anaesth. 2007;17:924-933. (Pubitemid 47339712)
2. Rochette A, Troncin R, Raux O, et al. Clonidine added to bupivacaine in neonatal spinal anesthesia: a prospective comparison in 124 preterm and term infants. Paediatr Anaesth. 2005; 15:1072-1077. (Pubitemid 43965384)
3. Pohl-Schickinger A, Lemmer J, Hubler M, et al. Intravenous clonidine infusion in infants after cardiovascular surgery. Paediatr Anaesth. 2008;18:217-222. (Pubitemid 351159911)
4. Parker RK, Connelly NR, Lucas T, et al. Epidural clonidine added to a bupivacaine infusion increases analgesic duration in labor without adverse maternal or fetal effects. J Anesth. 2007;21:142-147. (Pubitemid 46692004)
5. Ecoffey C. Pediatric regional anesthesia-update. Curr Opin Anaesthesiol. 2007;20:232-235.
6. Bergendahl H, Lonnqvist PA, Eksborg S. Clonidine in paediatric anaesthesia: review of the literature and comparison with benzodiazepines for premedication. Acta Anaesthesiol Scand. 2006;50:135-143. (Pubitemid 43340842)
7. Arenas-Lopez S, Riphagen S, Tibby SM, et al. Use of oral clonidine for sedation in ventilated paediatric intensive care patients. Intensive Care Med. 2004;30:1625-1629. (Pubitemid 39094965)
8. Ivani G, Bergendahl HT, Lampugnani E, et al. Plasma levels of clonidine following epidural bolus injection in children. Acta Anaesthesiol Scand. 1998;42:306-311. (Pubitemid 28131379)
9. Bergendahl HT, Eksborg S, Lonnqvist PA. Low-dose intravenous clonidine in children: plasma concentrations and haemodynamic response. Acta Anaesthesiol Scand. 1997;41:381-384. (Pubitemid 27140310)
10. Lonnqvist PA, Bergendahl HT, Eksborg S. Pharmacokinetics of clonidine after rectal administration in children. Anesthesiology. 1994;81:1097-1101. (Pubitemid 24340365)
11. Almenrader N, Larsson P, Passariello M, et al. Absorption pharmacokinetics of clonidine nasal drops in children. Paediatr Anaesth. 2009;19:257-261.
12. Seger DL. Clonidine toxicity revisited. J Toxicol Clin Toxicol. 2002;40:145-155. (Pubitemid 34755580)
13. Bamshad MJ, Wasserman GS. Pediatric clonidine intoxications. Vet Hum Toxicol. 1990;32:220-223. (Pubitemid 20245065)
14. Hoder EL, Leckman JF, Poulsen J, et al. Clonidine treatment of neonatal narcotic abstinence syndrome. Psychiatry Res. 1984;13:243-251. (Pubitemid 15219740)
15. Hoder EL, Leckman JF, Ehrenkranz R, Kleber H, Cohen DJ, Poulsen JA. Clonidine in neonatal narcotic-abstinence syndrome. N Engl J Med. 1981;305:1284. (Pubitemid 12234855)
16. Gowing LR, Farrell M, Ali RL, White JM. Alpha2-adrenergic agonists in opioid withdrawal. Addiction. 2002;97:49-58.
17. Agthe AG, Kim GR, Mathias KB, et al. Clonidine as an adjunct therapy to opioids for neonatal abstinence syndrome: a randomized, controlled trial. Pediatrics. 2009;123:e849-e856.
18. Little PJ, Price RR, Hinton RK, Kuhn CM. Role of noradrenergic hyperactivity in neonatal opiate abstinence. Drug Alcohol Depend. 1996;41:47-54. (Pubitemid 26185294)
19. Hamburg M, Tallman JF. Chronic morphine administration increases the apparent number of alpha 2-adrenergic receptors in rat brain. Nature. 1981;291:493-495. (Pubitemid 11093666)
20. Bird SJ, Kuhar MJ. Iontophoretic application of opiates to the locus coeruleus. Brain Res. 1977;122:523-533. (Pubitemid 8055009)
21. Aghajanian GK. Tolerance of locus coeruleus neurones to morphine and suppression of withdrawal response by clonidine. Nature. 1978;276:186-188. (Pubitemid 9068251)
22. Gold MS, Pottash AL, Sweeney DR, Kleber HD. Clonidine detoxification: a fourteen-day protocol for rapid opiate withdrawal. NIDA Res Monogr. 1979;27:226-232.
23. Gold MS, Redmond DE Jr, Kleber HD. Clonidine blocks acute opiate-withdrawal symptoms. Lancet. 1978;2:599-602. (Pubitemid 9009208)
24. Gold MS, Redmond DE Jr, Donabedian RK. Prolactin secretion, a measurable central effect of opiate-receptor antagonists. Lancet. 1978;1:323-324. (Pubitemid 8273572)
25. Charney DS, Heninger GR, Sternberg DE. Assessment of alpha 2 adrenergic autoreceptor function in humans: effects of oral yohimbine. Life Sci. 1982;30:2033-2041. (Pubitemid 12030205)
26. Arndts D, Doevendans J, Kirsten R, Heintz B. New aspects of the pharmacokinetics and pharmacodynamics of clonidine in man. Eur J Clin Pharmacol. 1983;24:21-30. (Pubitemid 13181781)
27. Arndts D. New aspects of the clinical pharmacology of clonidine. Chest. 1983;83:397-400. (Pubitemid 13153337)
28. Davies DS, Wing AM, Reid JL, Neill DM, Tippett P, Dollery CT. Pharmacokinetics and concentration-effect relationships of intervenous and oral clonidine. Clin Pharmacol Ther. 1977;21:593-601. (Pubitemid 8098143)
29. MacGregor TR, Relihan GL, Keirns JJ. Pharmacokinetics of oral sustained release clonidine in humans. Arzneimittelforschung. 1985;35:440-446. (Pubitemid 15152712)
30. Hulter HN, Licht JH, Ilnicki LP, Singh S. Clinical efficacy and pharmacokinetics of clonidine in hemodialysis and renal insufficiency. J Lab Clin Med. 1979;94:223-231. (Pubitemid 10208508)
31. Lowenthal DT, Affrime MB, Meyer A, Kim KE, Falkner B, Sharif K. Pharmacokinetics and pharmacodynamics of clonidine in varying states of renal function. Chest. 1983;83:386-390. (Pubitemid 13153333)
32. Buchanan ML, Easterling TR, Carr DB, et al. Clonidine pharmacokinetics in pregnancy. Drug Metab Dispos. 2009;37:702-705.
33. Anderson BJ, Holford NH. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol. 2008;48:303-332. (Pubitemid 351738156)
34. Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology-drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;349:1157-1167. (Pubitemid 37122329)
35. American Academy of Pediatrics Committee on Drugs. Neonatal drug withdrawal. Pediatrics. 1998;101:1079-1088.
36. Anderson BJ, Holford NH. Mechanistic basis of using body size and maturation to predict clearance in humans. Drug Metab Pharmacokinet. 2009;24:25-36.
37. Lindbom L, Ribbing J, Jonsson EN. Perl-speaks-NONMEM (PsN) - a Perl module for NONMEM related programming. Comput Methods Programs Biomed. 2004;75:85-94. (Pubitemid 38798039)
38. Frisk-Holmberg M, Paalzow L, Edlund PO. Clonidine kinetics in man - evidence for dose dependency and changed pharmacokinetics during chronic therapy. Br J Clin Pharmacol. 1981;12:653-658. (Pubitemid 11027978)
39. Frisk-Holmberg M, Edlund PO, Paalzow L. Pharmacokinetics of clonidine and its relation to the hypotensive effect in patients. Br J Clin Pharmacol. 1978;6:227-232. (Pubitemid 8388919)
40. Sumiya K, Homma M, Watanabe M, et al. Sedation and plasma concentration of clonidine hydrochloride for pre-anesthetic medication in pediatric surgery. Biol Pharm Bull. 2003; 26:421-423. (Pubitemid 39663583)
41. Rajagopalan P, Gastonguay MR. Population pharmacokinetics of ciprofloxacin in pediatric patients. J Clin Pharmacol. 2003;43:698-710. (Pubitemid 36759147)
42. Tremoulet AH, Capparelli EV, Patel P, et al. Population pharmacokinetics of lamivudine in human immunodeficiency virusexposed and -infected infants. Antimicrob Agents Chemother. 2007;51:4297-4302. (Pubitemid 350209880)
43. King JR, Kimberlin DW, Aldrovandi GM, Acosta EP. Antiretroviral pharmacokinetics in the paediatric population: a review. Clin Pharmacokinet. 2002;41:1115-1133. (Pubitemid 35398689)
44. Hayton WL, Stoeckel K. Age-associated changes in ceftriaxone pharmacokinetics. Clin Pharmacokinet. 1986;11:76-86. (Pubitemid 16164531)
45. Koepsell H, Schmitt BM, Gorboulev V. Organic cation transporters. Rev Physiol Biochem Pharmacol. 2003;150:36-90.
46. Chen N, Aleksa K, Woodland C, Rieder M, Koren G. Ontogeny of drug elimination by the human kidney. Pediatr Nephrol. 2006;21:160-168. (Pubitemid 43115865)
47. Friis-Hansen B. Body water compartments in children: changes during growth and related changes in body composition. Pediatrics. 1961;28:169-181.
48. Hooker AC, Staatz CE, Karlsson MO. Conditional weighted residuals (CWRES): a model diagnostic for the FOCE method. Pharm Res. 2007;24:2187-2197. (Pubitemid 350060706)