Pharmacokinetics and Safety of Extemporaneously Compounded Valacyclovir Oral Suspension in Pediatric Patients from 1 Month through 11 Years of Age

Kimberlin, David W.; Jacobs, Richard F.; Weller, S; Walt, Jan-Stefan van der; Heitman, Catherine K.; Man, Choy; Bradley, John S.

doi:10.1086/649212

Cited by 48 publications

(15 citation statements)

References 38 publications

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“…An oral alternative that is well absorbed is the prodrug valaciclovir. Oral therapy is not recommended due to reduced clearance in this age group (<3 months) 9 and is currently not licensed for the treatment of varicella infection in children less than 12 years old. 4 Whilst there is no clear guidance on the best dosing regimen, the drug has been used at a dose of 30 mg/kg 3 times a day 10 after discussion with experts but only in exceptional cases.…”

Section: Based On These Results What Treatment Would You Recommend?mentioning

confidence: 99%

Rash in a neonate

Jackson

2011

Journal of Clinical Virology

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Section: Based On These Results What Treatment Would You Recommend?mentioning

confidence: 99%

Rash in a neonate

Jackson

2011

Journal of Clinical Virology

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“…[7] Its mechanism of action, antiviral spectrum, and resistance are the same as acyclovir, whereas its oral bioavailability is superior to acyclovir. With an oral bioavailability ∼3- to 5-fold greater than oral acyclovir, valacyclovir can be administered less frequently and can achieve the plasma acyclovir concentrations similar to those seen with intravenous acyclovir in adults.…”

Section: Discussionmentioning

confidence: 99%

“…With an oral bioavailability ∼3- to 5-fold greater than oral acyclovir, valacyclovir can be administered less frequently and can achieve the plasma acyclovir concentrations similar to those seen with intravenous acyclovir in adults. [7,8] Among children (3 months–11 years of age) with HSV infection, multicenter studies indicate that the 20 mg/kg dose of the formula of the oral valacyclovir can result in favorable acyclovir blood concentrations and is well tolerated. [7] There are few reports on the efficacy of valacyclovir in the treatment of EH.…”

Section: Discussionmentioning

confidence: 99%

“…[7,8] Among children (3 months–11 years of age) with HSV infection, multicenter studies indicate that the 20 mg/kg dose of the formula of the oral valacyclovir can result in favorable acyclovir blood concentrations and is well tolerated. [7] There are few reports on the efficacy of valacyclovir in the treatment of EH. In adults, Wollenberg et al [3] recommend a 7-day course of oral valacyclovir (500 mg by mouth 3 times daily) for EH treatment, which can be prolonged according to the clinical course.…”

Section: Discussionmentioning

confidence: 99%

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Oral treatment with valacyclovir for HSV-2-associated eczema herpeticum in a 9-month-old infant

Zhuang

Ran

et al. 2016

Medicine

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Background:Eczema herpeticum is a rare, severe, and disseminated infection of herpes simplex virus in the setting of eczematous skin diseases.Methods:We experienced a case of this disease in a 9-month-old infant characterized by a sudden onset of monomorphic vesicles on the head, right lower leg, and two hands. The infant has a 7-month history of atopic dermatitis and his condition was initially regarded as a complication of atopic dermatitis and bacterial infection. After treatment of cefoperazone and dexamethasone, the eruptions got worse. The diagnosis of eczema herpeticum was made according to the clinical features and further confirmed by the findings of herpes simplex virus type 2.Results:The infant was cured by oral treatment with valacyclovir.Conclusion:The case highlights that the awareness for the sign of eczema herpeticum when diagnosing children with a sudden onset of disseminated vesicles in the setting of chronic skin disease should be increased. Oral valacyclovir may be an effective and convenient treatment option for pediatric outpatients with eczema herpeticum.

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“…An extemporaneously compounded oral solution of valacyclovir has not been sufficiently studied in neonates and young infants to warrant its use instead of oral acyclovir for antiviral suppression. 25 …”

Section: Discussionmentioning

confidence: 99%

Oral Acyclovir Suppression and Neurodevelopment after Neonatal Herpes

et al. 2011

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BACKGROUND Poor neurodevelopmental outcomes and recurrences of cutaneous lesions remain unacceptably frequent among survivors of neonatal herpes simplex virus (HSV) disease. METHODS We enrolled neonates with HSV disease in two parallel, identical, double-blind, placebo-controlled studies. Neonates with central nervous system (CNS) involvement were enrolled in one study, and neonates with skin, eye, and mouth involvement only were enrolled in the other. After completing a regimen of 14 to 21 days of parenteral acyclovir, the infants were randomly assigned to immediate acyclovir suppression (300 mg per square meter of body-surface area per dose orally, three times daily for 6 months) or placebo. Cutaneous recurrences were treated with open-label episodic therapy. RESULTS A total of 74 neonates were enrolled — 45 with CNS involvement and 29 with skin, eye, and mouth disease. The Mental Development Index of the Bayley Scales of Infant Development (in which scores range from 50 to 150, with a mean of 100 and with higher scores indicating better neurodevelopmental outcomes) was assessed in 28 of the 45 infants with CNS involvement (62%) at 12 months of age. After adjustment for covariates, infants with CNS involvement who had been randomly assigned to acyclovir suppression had significantly higher mean Bayley mental-development scores at 12 months than did infants randomly assigned to placebo (88.24 vs. 68.12, P = 0.046). Overall, there was a trend toward more neutropenia in the acyclovir group than in the placebo group (P = 0.09). CONCLUSIONS Infants surviving neonatal HSV disease with CNS involvement had improved neurodevelopmental outcomes when they received suppressive therapy with oral acyclovir for 6 months. (Funded by the National Institute of Allergy and Infectious Diseases; CASG 103 and CASG 104 ClinicalTrials.gov numbers, NCT00031460 and NCT00031447, respectively.)

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Pharmacokinetics and Safety of Extemporaneously Compounded Valacyclovir Oral Suspension in Pediatric Patients from 1 Month through 11 Years of Age

Cited by 48 publications

References 38 publications

Rash in a neonate

Rash in a neonate

Oral treatment with valacyclovir for HSV-2-associated eczema herpeticum in a 9-month-old infant

Oral Acyclovir Suppression and Neurodevelopment after Neonatal Herpes

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