Pharmacokinetics and safety of extemporaneously compounded valacyclovir oral suspension in pediatric patients from 1 month through 11 years of age

Clinical Infectious Diseases

Volumn 50, Issue 2, 2010, Pages 221-228

  Kimberlin, David W ^a   Jacobs, Richard F ^b   Weller, Stephen ^c   Van Walt, Jan Stefan Der ^e   Heitman, Catherine K ^c   Man, Choy Y ^c   Bradley, John S ^d  

^a University of Alabama at Birmingham   (United States)

^b ARKANSAS CHILDREN S HOSPITAL RESEARCH INSTITUTE   (United States)

^c GLAXOSMITHKLINE   (United States)

^d RADY CHILDREN'S HOSPITAL   (United States)

^e UNIVERSITY OF CAPE TOWN   (South Africa)

Author keywords

[No Author keywords available]

Indexed keywords

ACICLOVIR; VALACICLOVIR;

AGE DISTRIBUTION; ANTIVIRAL THERAPY; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CHILD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE INCREASE; DRUG ELIMINATION; DRUG FORMULATION; DRUG HALF LIFE; DRUG MONITORING; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; GROUPS BY AGE; HEMOLYTIC UREMIC SYNDROME; HERPES VIRUS INFECTION; HERPES ZOSTER; HOSPITALIZED CHILD; HUMAN; INFANT; INFECTION RISK; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; PRESCHOOL CHILD; PRIORITY JOURNAL; SCHOOL CHILD; SINGLE DRUG DOSE; SUSPENSION; THROMBOTIC THROMBOCYTOPENIC PURPURA; UNSPECIFIED SIDE EFFECT;

ACYCLOVIR; ADMINISTRATION, ORAL; ANTIVIRAL AGENTS; CHILD; CHILD, PRESCHOOL; FEMALE; HERPESVIRIDAE INFECTIONS; HUMANS; INFANT; MALE; SUSPENSIONS; VALINE;

EID: 73649143915     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/649212     Document Type: Article

References (39)

1. Xu F, Lee FK, Morrow RA, et al. Seroprevalence of herpes simplex virus type 1 in children in the United States. J Pediatr 2007; 151(4):374-377. (Pubitemid 47432656)
2. Xu F, Sternberg MR, Kottiri BJ, et al. Trends in herpes simplex virus type 1 and type 2 seroprevalence in the United States. JAMA 2006; 296(8):964-973. (Pubitemid 44285373)
3. Galil K, Brown C, Lin F, Seward J. Hospitalizations for varicella in the United States, 1988 to 1999. Pediatr Infect Dis J 2002; 21(10);931-935.
4. Davis MM, Patel MS, Gebremariam A. Decline in varicella-related hospitalizations and expenditures for children and adults after introduction of varicella vaccine in the United States. Pediatrics 2004; 114(3):786-792. (Pubitemid 41529540)
5. Vazquez M, LaRussa PS, Gershon AA, Steinberg SP, Freudigman K, Shapiro ED. The effectiveness of the varicella vaccine in clinical practice. N Engl J Med 2001; 344(13):955-960.
6. Lopez AS, Guris D, Zimmerman L, et al. One dose of varicella vaccine does not prevent school outbreaks; is it time for a second dose? Pediatrics 2006; 117(6);e1070-e1077.
7. Kimberlin DW, Lin CY, Jacobs RF, et al. Safety and efficacy of highdose intravenous acyclovir in the management of neonatal herpes simplex virus infections. Pediatrics 2001; 108(2);230-238.
8. Whitley RJ, Alford CA, Hirsch MS, et al. Vidarabine versus acyclovir therapy in herpes simplex encephalitis. N Engl J Med 1986; 314(3);144-149.
9. Whitley RJ, Gnann JW Jr, Hinthorn D, et al; the NIAID Collaborative Antiviral Study Group. Disseminated herpes zoster in the immunocompromised host; a comparative trial of acyclovir and vidarabine. J Infect Dis 1992; 165(3);450-455.
10. Whitley R, Arvin A, Prober C, et al. A controlled trial comparing vidarabine with acyclovir in neonatal herpes simplex virus infection. N Engl J Med 1991; 324(7);444-449.
11. Nyerges G, Meszner Z, Gyarmati E, Kerpel-Fronius S. Acyclovir prevents dissemination of varicella in immunocompromised children. J Infect Dis 1988; 157(2);309-313.
12. Prober CG, Kirk LE, Kceney RE. Acyclovir therapy of chickenpox in immunosuppressed children; a collaborative study. J Pediatr 1982; 101(4):622-625.
13. Balfour HH Jr, Bean B, Laskin OL, et al. Acyclovir halts progression of herpes zoster in immunocompromised patients. N Engl J Med 1983; 308(24):1448-1453.
14. Spmance SL, Stewart JC, Rowe NH, McKeough MB, Wenerstrom G, Freeman DJ. Treatment of recurrent herpes simplex labialis with oral acyclovir. J Infect Dis 1990; 161(2):185-190. (Pubitemid 20056644)
15. Aoki FY, Law BJ, Hammond GW, et al. Acyclovir (ACV) suspension for treatment of acute herpes simplex virus (HSV) gingivostomatitis in children: a placebo (PL) controlled, double blind trial. In: Program and abstracts of the 33rd Interscience Conference on Antimicrobial Agents and Chemotherapy. 1993. Abstract 1530.
16. Balfour HH Jr, Rotbart HA, Feldman S, et al. Acyclovir treatment of varicella in otherwise healthy adolescents. J Pediatr 1992; 120(4 pt 1):627-633.
17. Dunkle LM, Arvin AM, Whitley RJ, et al. A controlled trial of acyclovir for chickenpox in normal children. N Engl J Med 1991; 325(22):1539-1544.
18. Wood MJ, Ogan PH, McKendrick MW, Care CD, McGill JI, Webb EM. Efficacy of oral acyclovir treatment of acute herpes zoster. Am J Med 1988; 85(2A):79-83. (Pubitemid 18220478)
19. McGill J, MacDonald DR, Fall C, McKendrick GD, Copplestone A. Intravenous acyclovir in acute herpes zoster infection. J Infect 1983; 6(2):157-161.
20. Lai L, Xu Z, Zhou J, Lee KD, Amidon GL. Molecular basis of prodrug activation by human valacyclovirase, an alpha-amino acid ester hydrolase. J Biol Chem 2008; 283(14):9318-9327.
21. Kimberlin DW. Antiviral agents. In: Long SS, Pickering LK, Prober CG, eds. Principles and practice of pediatric infectious diseases. 3rd ed. Philadelphia, PA: Churchill Livingstone Elsevier, 2008:1470-1488.
22. Schwartz GJ, Brion LP, Spitzer A. The use of plasma creatinine concentration for estimating glomerular filtration rate in infants, children, and adolescents. Pediatr Clin North Am 1987; 34(3):571-590. (Pubitemid 17080631)
23. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Published October 2000. http://www.tsghirb.ndmctsgh.edu.tw/doc/21DeclarationOfHelsinki.pdf. Accessed 3 December 2009.
24. Valacyclovir package insert, http://us.gsk.com/products/assets/us- valtrex.pdf. Published 2008. Accessed 3 December 2009.
25. Rowland M, Tozer TN. Clinical pharmacokinetics: concepts and applications. Philadelphia, PA: Lea & Febiger, 1980:222-225.
26. Weiler S, Blum MR, Doucette M, et al. Pharmacokinetics of the acyclovir pro-drug valaciclovir after escalating single- and multiple-dose administration to normal volunteers. Clin Pharmacol Ther 1993; 54(6):595-605. (Pubitemid 24028442)
27. Blum MR, Liao SH, de Miranda P. Overview of acyclovir pharmacokinetic disposition in adults and children. Am J Med 1982; 73(1A):186-192. (Pubitemid 12067782)
28. Eksborg S, Pal N, Kalin M, Palm C, Soderhall S. Pharmacokinetics of acyclovir in immunocompromised children with leukopenia and mucositis after chemotherapy: can intravenous acyclovir be substituted by oral valacyclovir? Med Pediatr Oncol 2002; 38(4):240-246.
29. Bomgaars L, Thompson P, Berg S, Serabe B, Aleksic A, Blaney S. Valacyclovir and acyclovir pharmacokinetics in immunocompromised children. Pediatr Blood Cancer 2008; 51(4):504-508.
30. Nadal D, Leverger G, Sokal EM, et al. An investigation of the steadystate pharmacokinetics of oral valacyclovir in immunocompromised children. J Infect Dis 2002; 186(suppl 1):S123-S130. (Pubitemid 35178859)
31. Kimberlin DW, Acosta EP, Sanchez PJ, et al. Pharmacokinetic and pharmacodynamic assessment of oral valganciclovir in the treatment of symptomatic congenital cytomegalovirus disease. J Infect Dis 2008; 197(6):836-845.
32. Shen H, Smith DE, Brosius FC III. Developmental expression of PEPT1 and PEPT2 in rat small intestine, colon, and kidney. Pediatr Res 2001; 49(6):789-795. (Pubitemid 32522055)
33. Balimane PV, Tamai I, Guo A, et al. Direct evidence for peptide transporter (PepTl )-mediated uptake of a nonpcptide prodrug, valacyclovir. Biochem Biophys Res Commun 1998; 250(2):246-251. (Pubitemid 28463863)
34. Cao X, Gibbs ST, Fang L, et al. Why is it challenging to predict intestinal drug absorption and oral bioavailability in human using rat model. Pharm Res 2006; 23(8):1675-1686. (Pubitemid 44200529)
35. Spruance SL, Hamill ML, Hoge WS, Davis LG, Mills J. Acyclovir prevents reactivation of herpes simplex labialis in skiers. JAMA 1988; 260(11):1597-1599. (Pubitemid 18209565)
36. Gold D, Corey L. Acyclovir prophylaxis for herpes simplex virus infection. Antimicrob Agents Chemother 1987; 31(3):361-367. (Pubitemid 17027121)
37. Spruance SL, Freeman DJ, Stewart JC, et al. The natural history of ultraviolet radiation-induced herpes simplex labialis and response to therapy with peroral and topical formulations of acyclovir. J Infect Dis 1991; 163(4):728-734.
38. Kimberlin D, Powell D, Gruber W, et al. Administration of oral acyclovir suppressive therapy after neonatal herpes simplex virus disease limited to the skin, eyes and mouth: results of a phase I/II trial. Pediatr Infect Dis J 1996; 15(3):247-254.
39. Fonseca-Aten M, Messina AF, Jafri HS, Sanchez PJ. Herpes simplex virus encephalitis during suppressive therapy with acyclovir in a premature infant. Pediatrics 2005; 115(3):804-809. (Pubitemid 43373049)