Document Detail


Safety and pharmacokinetics of multiple-dose anidulafungin in infants and neonates.
MedLine Citation:
PMID:  21412233     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Candida infections are common and often fatal in infants and neonates. Anidulafungin has excellent activity against Candida species, but the pharmacokinetics (PK) and safety of the drug in infants and neonates are unknown. The object of our study was to determine the PK and safety of anidulafungin in infants and neonates at risk for invasive candidiasis. Intravenous anidulafungin (1.5 mg/kg/day maintenance dose) was administered to 15 infants and neonates over 3 to 5 days. Plasma samples were collected after the first dose and again after the third to fifth doses. The pharmacokinetic parameters of the drug were determined by noncompartmental analysis. Safety was assessed using National Cancer Institute common toxicity criteria. The study showed that drug exposure levels were similar between neonates and infants; the median areas under the concentration-time curve (range) was 75 (30-109) µg·h/ml and 98 (55-278) µg·h/ml (P = 0.12) for neonates and infants, respectively. No drug-related serious adverse events were observed. The study results indicate that neonates and infants receiving 1.5 mg/kg/day have anidulafungin exposure levels similar to those in children receiving similar weight-based dosing and in adult patients receiving 100 mg/day.
Authors:
M Cohen-Wolkowiez; D K Benjamin; L Piper; I M Cheifetz; C Moran; P Liu; J Aram; A D M Kashuba; E Capparelli; T J Walsh; W W Hope; P B Smith
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Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2011-03-16
Journal Detail:
Title:  Clinical pharmacology and therapeutics     Volume:  89     ISSN:  1532-6535     ISO Abbreviation:  Clin. Pharmacol. Ther.     Publication Date:  2011 May 
Date Detail:
Created Date:  2011-04-22     Completed Date:  2011-06-21     Revised Date:  2014-09-08    
Medline Journal Info:
Nlm Unique ID:  0372741     Medline TA:  Clin Pharmacol Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  702-7     Citation Subset:  AIM; IM    
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MeSH Terms
Descriptor/Qualifier:
Age Factors
Antifungal Agents / administration & dosage,  adverse effects*,  pharmacokinetics*
Area Under Curve
Candida / drug effects
Candidiasis, Invasive / metabolism,  prevention & control
Dose-Response Relationship, Drug
Echinocandins / administration & dosage,  adverse effects*,  pharmacokinetics*
Female
Humans
Infant
Infant, Newborn
Male
Grant Support
ID/Acronym/Agency:
1K23HD060040-01/HD/NICHD NIH HHS; 1K23HD064814-01/HD/NICHD NIH HHS; 1K24HD058735-01/HD/NICHD NIH HHS; 1R01FD003519-01/FD/FDA HHS; 1R01HD057956-02/HD/NICHD NIH HHS; 1U10-HD45962-06/HD/NICHD NIH HHS; K23 HD064814/HD/NICHD NIH HHS; K23 HD064814-01/HD/NICHD NIH HHS; K24 HD058735/HD/NICHD NIH HHS; P30AI37260/AI/NIAID NIH HHS; R34AI087065/AI/NIAID NIH HHS
Chemical
Reg. No./Substance:
0/Antifungal Agents; 0/Echinocandins; 9HLM53094I/anidulafungin
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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