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Título : Pharmacokinetics and safety of caspofungin in neonates and infants less than 3 months of age
Creador: Sáez Llorens, Xavier
Nivel de acceso: Open access
Palabras clave : Antifúngicos - administración & dosificación
Antifúngicos -efectos adversos
Antifúngicos -sangre
Antifúngicos - farmacocinética
Body Surface Area
Candidiasis - quimioterapia
Ensayo Clínico
Esquema de Medicación
Equinocandinas - administración & dosificación
Equinocandinas - efectos adversos
Equinocandinas - sangre
Equinocandinas - farmacocinética
fiebre - inducido químicamente
Hipertensión - inducido químicamente
Hiperventilación - inducido químicamente
Lactante
Recién nacido
Infusiones Intravenosas
Antifungal Agents - administration & dosage
Antifungal Agents - adverse effects
Antifungal Agents - blood
Antifungal Agents - pharmacokinetics
Body Surface Area
Candidiasis - drug therapy
Clinical Trials
Drug Administration Schedule
Echinocandins - administration & dosage
Echinocandins - adverse effects
Echinocandins - blood
Echinocandins - pharmacokinetics
Fever - chemically induced Hypertension - chemically induced
Hyperventilation - chemically induced
Infant Infant, Newborn
Infusions, Intravenous
Descripción : Candida infections represent a major threat in neonatal intensive care units. This is the first prospective study to obtain caspofungin plasma levels and safety data for neonates and very young infants. Patients of <3 months of age receiving intravenous amphotericin B for documented or highly suspected candidiasis were enrolled in a single-dose (n = 6) or subsequent multiple-dose (n = 12) panel; all received caspofungin at 25 mg/m 2 once daily as a 1-hour infusion. Caspofungin plasma levels were measured by high-performance liquid chromatography and compared to historical data from adults. Patient chronological ages ranged from 1 to 11 weeks, and weights ranged from 0.68 to 3.8 kg. Gestational ages ranged from 24 to 41 weeks. Geometric mean (GM) peak (C 1 h) and trough (C 24 h) caspofungin levels were 8.2 and 1.8 μg/ml, respectively, on day 1, and 11.1 and 2.4 μ/ml, respectively, on day 4. GM ratios for C 1 h and C 24 h for neonates/infants relative to adults receiving caspofungin at 50 mg/day were 1.07 and 1.36, respectively, on day 1, and 1.18 and 1.21, respectively, on day 4. Clinical and laboratory adverse events occurred in 17 (94%) and 8 (44%) patients, respectively. Five patients (28%) had serious adverse events, none of which were considered drug related. Caspofungin at 25 mg/m 2 once daily was well tolerated in this group of neonates/infants of <3 months of age and appears to provide relatively similar plasma exposure to that obtained in adults receiving 50 mg/day. However, the small number of patients studied precludes any definitive recommendations about caspofungin dosing for this group comprising a broad range of ages and weights. Copyright © 2009, American Society for Microbiology. All Rights Reserved.
Colaborador(es) u otros Autores: Macias M
Maiya P
Pineros J
Jafri HS
Chatterjee A
Ruiz G
Raghavan J
Bradshaw SK
Kartsonis NA
Sun P
Strohmaier KM
Fallon M
Bi S
Stone JA
Chow JW
Fecha de publicación : 2009
Tipo de publicación: Artículo
Formato: pdf
Identificador del Recurso : 10.1128/AAC.00868-08
Fuente: Antimicrobial Agents and Chemotherapy 53(3):869 - 875
URI : http://repositorio.pediatria.gob.mx:8180/handle/20.500.12103/2684
Idioma: eng
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