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Página de Inicio arrow Artículos Científicos arrow Safety and Pharmacokinetics of Repeat-Dose Micafungin in Young Infants
Safety and Pharmacokinetics of Repeat-Dose Micafungin in Young Infants Imprimir E-Mail
Clinical Pharmacology & Therapeutics (2009); advance online publication 4 November 2009. doi:10.1038/clpt.2009.200

Safety and Pharmacokinetics of Repeat-Dose Micafungin in Young Infants

D K Benjamin Jr1, P B Smith1, A Arrieta2, L Castro3, P J Sánchez4, D Kaufman5, L J Arnold6, L L Kovanda6, T Sawamoto6, D N Buell6, W W Hope7 and T J Walsh8


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Abstract
Given the risk of central nervous system infection, relatively high weight-based echinocandin dosages may be required for the successful treatment of invasive candidiasis and candidemia in young infants. This open-label study assessed the safety and pharmacokinetics (PK) of micafungin in 13 young infants (>48 h and <120 days of life) with suspected candidemia or invasive candidiasis. Infants of body weight 1,000 and <1,000 g received 7 and 10 mg/kg/day, respectively, for a minimum of 4–5 days. In the 7-mg/kg/day group, the mean baseline weight and gestational age were 2,101 g and 30 weeks, respectively; in the 10-mg/kg/day group, they were 688 g and 25 weeks, respectively. The median pharmacokinetic values for the 7- and 10-mg/kg/day groups, respectively, were as follows: area under the concentration–time curve from 0 to 24 h (AUC0–24), 258.1 and 291.2 gh/ml; clearance at steady state adjusted for body weight, 0.45 and 0.57 ml/min/kg; maximum plasma concentration, 23.3 and 24.9  g/ml; and volume of distribution at steady state adjusted for body weight, 341.4 and 542.8 ml/kg. No deaths or discontinuations from treatment occurred. These data suggest that micafungin dosages of 7 and 10 mg/kg/day are well tolerated and provide exposure levels that have been shown (in animal models) to be adequate for central nervous system coverage.
 
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