Use of antibacterial agents in the neonate: 50 years of experience with vancomycin administration

Seminars in Fetal and Neonatal Medicine

Volumn 18, Issue 1, 2013, Pages 28-34

  Jacqz Aigrain, Evelyne ^a,b,c   Zhao, Wei ^b,c   Sharland, Mike ^d   van den Anker, John N ^e  

^a UNIVERSITÉ PARIS DESCARTES   (France)

^b HÔPITAL ROBERT DEBRÉ   (France)

^c INSERM   (France)

^d ST GEORGE S HOSPITAL   (United Kingdom)

^e GEORGE WASHINGTON UNIVERSITY   (United States)

Author keywords

Antibiotics; Neonates; Nephrotoxicity; Ototoxicity; Pharmacokinetics; Vancomycin

Indexed keywords

VANCOMYCIN;

CHILL; CLINICAL PRACTICE; CONTINUOUS INFUSION; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG FORMULATION; DRUG MONITORING; DRUG SAFETY; EOSINOPHILIA; HUMAN; NEPHROTOXICITY; NEUTROPENIA; NEWBORN SEPSIS; OTOTOXICITY; REVIEW; THROMBOCYTOPENIA; THROMBOPHLEBITIS; TREATMENT INDICATION;

ANTI-BACTERIAL AGENTS; DRUG MONITORING; HUMANS; INFANT, NEWBORN; INTENSIVE CARE UNITS, NEONATAL; MICROBIAL SENSITIVITY TESTS; SEPSIS; VANCOMYCIN;

EID: 84871931726     PISSN: 1744165X     EISSN: 18780946     Source Type: Journal    
DOI: 10.1016/j.siny.2012.10.003     Document Type: Review

References (62)

1. Conroy S., McIntyre J. The use of unlicensed and off-label medicines in the neonate. Semin Fetal Neonatal Med 2005, 10:115-122.
2. Pandolfini C., Bonati M. A literature review on off-label drug use in children. Eur J Pediatr 2005, 164:552-558.
3. Dawson P.M. Vancomycin and gentamicin in neonates: hindsight, current controversies, and forethought. J Perinat Neonatal Nurs 2002, 16:54-72.
4. Rubin L.G., Sánchez P.J., Siegel J., Levine G., Saiman L., Jarvis W.R. Evaluation and treatment of neonates with suspected late-onset sepsis: a survey of neonatologists' practices. Pediatrics 2002, 110:e42. Pediatric Prevention Network.
5. European Medicines Agency Revised priority list for studies into off-patent paediatric medicinal products (EMA/98717/2012) 2009, EMA, London. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500004017.pdf.
6. Cohen-Wolkowiez M., Moran C., Benjamin D.K., et al. Early and late onset sepsis in late preterm infants. Pediatr Infect Dis J 2009, 28:1052-1057.
7. Koenig J.M., Keenan W.J. Group B streptococcus and early-onset sepsis in the era of maternal prophylaxis. Pediatr Clin North Am 2009, 56:689.
8. Tudela C.M., Stewart R.D., Roberts S.W., et al. Intrapartum evidence of early-onset group B streptococcus. Obstet Gynecol 2012, 119:626-629.
9. Stoll B.J., Gordon T., Korones S.B., et al. Late-onset sepsis in very low birth weight neonates: a report from the National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr 1996, 129:63-71.
10. Stoll B.J., Hansen N., Fanaroff A.A., et al. Changes in pathogens causing early-onset sepsis in very-low-birth-weight infants. N Engl J Med 2002, 347:240-247.
11. Downey L.C., Smith P.B., Benjamin D.K. Risk factors and prevention of late onset sepsis in premature infants. Early Hum Dev 2010, 86:7-12.
12. Edmond K., Zaidi A. New approaches to preventing, diagnosing, and treating neonatal sepsis. PLoS Med 2010, 7:e1000213.
13. Gordon A., Jeffery H.E. Antibiotic regimens for suspected late onset sepsis in newborn infants. Cochrane Database Syst Rev 2005, 3:CD004501.
14. Mtitimila E.I., Cooke R.W. Antibiotic regimens for suspected early neonatal sepsis. Cochrane Database Syst Rev 2004, 4:CD004495.
15. Reynolds P.E. Structure, biochemistry and mechanism of action of glycopeptide antibiotics. Eur J Clin Microbiol Infect Dis 1989, 8:943-950.
16. Sun H., Maderazo E.G., Krusell A.R. Serum protein-binding characteristics of vancomycin. Antimicrob Agents Chemother 1993, 37:1132-1136.
17. Lundstrom T.S., Sobel J.D. Antibiotics for gram-positive bacterial infections: vancomycin, quinupristin-dalfopristin, linezolid, and daptomycin. Infect Dis Clin North Am 2004, 18:651-668.
18. Rybak M.J., Albrecht L.M., Berman J.R., Warbasse L.H., Svensson C.K. Vancomycin pharmacokinetics in burn patients and intravenous drug abusers. Antimicrob Agents Chemother 1990, 34:792-795.
19. Golper T.A., Noonan H.M., Elzinga L., et al. Vancomycin pharmacokinetics, renal handling, and nonrenal clearances in normal human subjects. Clin Pharmacol Ther 1988, 43:565-570.
20. de Hoog M., Mouton J.W., van den Anker J.N. Vancomycin: pharmacokinetics and administration regimens in neonates. Clin Pharmacokinet 2004, 43:417-440.
21. Baxter Healthcare Corp. Label information. Vancomycin hydrochloride injection solution. Deerfield, IL: Baxter Healthcare Corp. ; February 2012. http://www.medlibrary.com.
22. Wysocki M., Delatour F., Faurisson F., et al. Continuous versus intermittent infusion of vancomycin in severe staphylococcal infections: prospective multicenter randomized study. Antimicrob Agents Chemother 2001, 45:2460-2467.
23. Wysocki M., Delatour F., Faurisson F., et al. Continuous versus intermittent infusion of vancomycin in severe staphylococcal infections: prospective multicenter randomized study. Antimicrob Agents Chemother 2009, 53:1863-1867.
24. Pea F., Furlanut M., Negri C., et al. Prospectively validated dosing nomograms for maximizing the pharmacodynamics of vancomycin administered by continuous infusion in critically ill patients. Antimicrob Agents Chemother 2001, 45:2460-2467.
25. Cataldo M.A., Tacconelli E., Grilli E., Pea F., Petrosillo N. Continuous versus intermittent infusion of vancomycin for the treatment of gram-positive infections: systematic review and meta-analysis. J Antimicrob Chemother 2012, 67:17-24.
26. Plan O., Cambonie G., Barbotte E., et al. Continuous-infusion vancomycin therapy for preterm neonates with suspected or documented gram-positive infections: a new dosage schedule. Arch Dis Child Fetal Neonatal Ed 2008, 93:418-421.
27. Pawlotsky F., Thomas A., Kergueris M.F., Debillon T., Roze J.C. Constant rate infusion of vancomycin in premature neonates: a new dosage schedule. Br J Clin Pharmacol 1998, 46:163-167.
28. Oudin C., Vialet R., Boulamery A., Martin C., Simon N. Vancomycin prescription in neonates and young infants: toward a simplified dosage. Arch Dis Child Fetal Neonatal Ed 2011, 96:365-370.
29. World Health Organization Marketing authorization of pharmaceutical products with special reference to multisource (generic) products: a manual for a drug regulatory authority 1999, WHO, Geneva. http://apps.who.int/prequal/info_general/documents/WHO_DMP_RGS_98_5_R.pdf.
30. Jong G.W. In vivo inferiority of generic product compared with branded vancomycin: a paradigm shift. Ther Drug Monit 2012, 34:2-3.
31. Vesga O., Agudelo M., Salazar B.E., Rodriguez C.A., Zuluaga A.F. Generic vancomycin products fail in vivo despite being pharmaceutical equivalents of the innovator. Antimicrob Agents Chemother 2010, 54:3271-3279.
32. Rodriguez C.A., Agudelo M., Zuluaga A.F., Vesga O. Generic vancomycin enriches resistant subpopulations of Staphylococcus aureus after exposure in a neutropenic mouse thigh infection model. Antimicrob Agents Chemother 2012, 56:243-247.
33. Zuluaga A.F., Agudelo M., Cardeño J.J., Rodriguez C.A., Vesga O. Determination of therapeutic equivalence of generic products of gentamicin in the neutropenic mouse thigh infection model. PLoS One 2010, 5:e10744.
34. Rodriguez C.A., Agudelo M., Zuluaga A.F., Vesga O. In vitro and in vivo comparison of the anti-staphylococcal efficacy of generic products and the innovator of oxacillin. BMC Infect Dis 2010, 10:153.
35. Bellanti F., Della Pasqua O. Modelling and simulation as research tools in paediatric drug development. Eur J Clin Pharmacol 2011, 67:75-86.
36. Marsot A., Boulamery A., Bruguerolle B., Simon N. Vancomycin: a review of population pharmacokinetic analyses. Clin Pharmacokinet 2012, 51:1-13.
37. Brendel K., Dartois C., Comets E., et al. Are population pharmacokinetic and/or pharmacodynamic models adequately evaluated? A survey of the literature from 2002 to 2004. Clin Pharmacokinet 2007, 46:221-234.
38. Allegaert K., Anderson B.J., van den Anker J.N., Vanhaesebrouck S., de Zegher F. Renal drug clearance in preterm neonates: relation to prenatal growth. Ther Drug Monit 2007, 29:284-291.
39. Kimura T., Sunakawa K., Matsuura N., Kubo H., Shimada S., Yago K. Population pharmacokinetics of arbekacin, vancomycin, and panipenem in neonates. Antimicrob Agents Chemother 2004, 48:1159-1167.
40. Lo Y.L., van Hasselt J.G., Heng S.C., Lim C.T., Lee T.C., Charles B.G. Population pharmacokinetics of vancomycin in premature Malaysian neonates: identification of predictors for dosing determination. Antimicrob Agents Chemother 2010, 54:2626-2632.
41. Marqués-Miñana M.R., Saadeddin A., Peris J.E. Population pharmacokinetic analysis of vancomycin in neonates. A new proposal of initial dosage guideline. Br J Clin Pharmacol 2010, 70:713-720.
42. Grimsley C., Thomson A.H. Pharmacokinetics and dose requirements of vancomycin in neonates. Arch Dis Child Fetal Neonatal Ed 1999, 81:F221-F227.
43. Capparelli E.V., Lane J.R., Romanowski G.L., et al. The influences of renal function and maturation on vancomycin elimination in newborns and infants. J Clin Pharmacol 2001, 41:927-934.
44. Zhao W, Kaguelidou F, Biran V, et al. External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical settings. Br J Clin Pharmacol [Epub ahead of print]. http://dx.doi.org.10.1111/j.1365-2125.2012.04406.x.
45. United States Food and Drug Administration. Guidance for industry: exposure-response relationships - study design, data analysis, and regulatory applications. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072109.pdf.
46. European Medicines Agency. Points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (Doc. Ref. CPMP/EWP/2655/99). http://www.ema.europa.eu/docs/en_GB/document_library/Scientificguideline/2009/09/WC500003420.pdf.
47. European Medicines Agency. Note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 1). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003417.pdf.
48. Moise-Broder P.A., Forrest A., Birmingham M.C., Schentag J.J. Pharmacodynamics of vancomycin and other antimicrobials in patients with Staphylococcus aureus lower respiratory tract infections. Clin Pharmacokinet 2004, 43:925-942.
49. Ho P.L., Lo P.Y., Chow K.H., et al. Vancomycin MIC creep in MRSA isolates from 1997 to 2008 in a healthcare region in Hong Kong. J Infect 2010, 60:140-145.
50. Mohr J.F., Murray B.E. Point: vancomycin is not obsolete for the treatment of infection caused by methicillin-resistant Staphylococcus aureus. Clin Infect Dis 2007, 44:1536-1542.
51. Frymoyer A., Hersh A.L., Coralic Z., Benet L.Z., Joseph Guglielmo B. Prediction of vancomycin pharmacodynamics in children with invasive methicillin-resistant Staphylococcus aureus infections: a Monte Carlo simulation. Clin Ther 2010, 32:534-542.
52. Rybak M.J., Lomaestro B.M., Rotschafer J.C., et al. Therapeutic monitoring of vancomycin in adults: summary of consensus recommendations from the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Pharmacotherapy 2009, 29:1275-1279.
53. Rodvold K.A., Everett J.A., Pryka R.D., Kraus D.M. Pharmacokinetics and administration regimens of vancomycin in neonates, infants and children. Clin Pharmacokinet 1997, 33:32-51.
54. Elyasi S., Khalili H., Dashti-Khavidaki S., Mohammadpour A. Vancomycin-induced nephrotoxicity: mechanism, incidence, risk factors and special populations. A literature review. Eur J Clin Pharmacol 2012, 68:1243-1255.
55. Bailie G.R., Neal D. Vancomycin ototoxicity and nephrotoxicity. A review. Med Toxicol Adverse Drug Exp 1988, 3:376-386.
56. McKamy S., Hernandez E., Jahng M., Moriwaki T., Deveikis A., Le J. Incidence and risk factors influencing the development of vancomycin nephrotoxicity in children. J Pediatr 2011, 158:422-426.
57. Odio C., McCracken G.H., Nelson J.D. Nephrotoxicity associated with vancomycin-aminoglycoside therapy in four children. J Pediatr 1984, 105:491-493.
58. Goren M.P., Baker D.K., Shenep J.L. Vancomycin does not enhance amikacin-induced tubular nephrotoxicity in children. Pediatr Infect Dis J 1989, 8:278-282.
59. Linder N., Edwards R., MeClead R., Mortensen M.E., Walson P., Koren G. Safety of vancomycin with or without gentamicin in neonates. Neonatal Network 1993, 12:27-30.
60. Schaad U.B., Nelson J.D., McCracken G.H. Pharmacology and efficacy of vancomycin for staphylococcal infections in children. Rev Infect Dis 1981, 3:S282-S288.
61. Burkhart K.K., Metcalf S., Shurnas E., et al. Exchange transfusion and multidose activated charcoal following vancomycin overdose. J Toxicol Clin Toxicol 1992, 30:285-294.
62. de Hoog M., van Zanten B.A., Hop W.C., Overbosch E., Weisglas-Kuperus N., van den Anker J.N. Newborn hearing screening: tobramycin and vancomycin are not risk factors for hearing loss. J Pediatr 2003, 142:41-46.