Academic Journal
Single-Dose Pharmacokinetics of Famciclovir in Infants and Population Pharmacokinetic Analysis in Infants and Children
| العنوان: | Single-Dose Pharmacokinetics of Famciclovir in Infants and Population Pharmacokinetic Analysis in Infants and Children |
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| المؤلفون: | Blumer, Jeffrey, Rodriguez, Adib, Sánchez, Pablo J., Sallas, William, Kaiser, Guenther, Hamed, Kamal |
| المصدر: | Antimicrobial Agents and Chemotherapy ; volume 54, issue 5, page 2032-2041 ; ISSN 0066-4804 1098-6596 |
| بيانات النشر: | American Society for Microbiology |
| سنة النشر: | 2010 |
| الوصف: | A multicenter, open-label study evaluated the single-dose pharmacokinetics and safety of a pediatric oral famciclovir (prodrug of penciclovir) formulation in infants aged 1 to 12 months with suspicion or evidence of herpes simplex virus infection. Individualized single doses of famciclovir based on the infant's body weight ranged from 25 to 175 mg. Eighteen infants were enrolled (1 to <3 months old [ n = 8], 3 to <6 months old [ n = 5], and 6 to 12 months old [ n = 5]). Seventeen infants were included in the pharmacokinetic analysis; one infant experienced immediate emesis and was excluded. Mean C max and AUC 0-6 values of penciclovir in infants <6 months of age were ∼3- to 4-fold lower than those in the 6- to 12-month age group. Specifically, mean AUC 0-6 was 2.2 μg·h/ml in infants aged 1 to <3 months, 3.2 μg·h/ml in infants aged 3 to <6 months, and 8.8 μg·h/ml in infants aged 6 to 12 months. These data suggested that the dose administered to infants <6 months was less than optimal. Eight (44.4%) infants experienced at least one adverse event with gastrointestinal events reported most commonly. An updated pharmacokinetic analysis was conducted, which incorporated the data in infants from the present study and previously published data on children 1 to 12 years of age. An eight-step dosing regimen was derived that targeted exposure in infants and children 6 months to 12 years of age to match the penciclovir AUC seen in adults after a 500-mg dose of famciclovir. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1128/aac.01508-09 |
| DOI: | 10.1128/AAC.01508-09 |
| الاتاحة: | http://dx.doi.org/10.1128/aac.01508-09 https://journals.asm.org/doi/pdf/10.1128/AAC.01508-09 |
| Rights: | https://journals.asm.org/non-commercial-tdm-license |
| رقم الانضمام: | edsbas.836B2D2C |
| قاعدة البيانات: | BASE |
| DOI: | 10.1128/aac.01508-09 |
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