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1.
J Pediatr ; 222: 236-239, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-32171562

RESUMEN

Lactation is contraindicated for women with sickle cell anemia receiving hydroxyurea therapy, despite sparse pharmacokinetics data. In 16 women who were lactating volunteers, we documented hydroxyurea transferred into breastmilk with a relative infant dosage of 3.4%, which is below the recommended 5%-10% safety threshold. Breastfeeding should be permitted for women taking daily oral hydroxyurea.


Asunto(s)
Anemia de Células Falciformes/tratamiento farmacológico , Hidroxiurea/farmacocinética , Lactancia/efectos de los fármacos , Leche Humana/metabolismo , Adulto , Anemia de Células Falciformes/metabolismo , Antineoplásicos/farmacocinética , Antidrepanocíticos , Femenino , Humanos , Leche Humana/efectos de los fármacos
3.
J Pediatr ; 167(6): 1214-20.e3, 2015 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-26364984

RESUMEN

OBJECTIVE: To characterize the population pharmacokinetics of oral methadone in neonates requiring pharmacologic treatment of neonatal abstinence syndrome and to develop a pharmacokinetic (PK) model toward an evidence-based treatment protocol. STUDY DESIGN: Based on a methadone dosing protocol, serum concentrations of methadone and its metabolites were assessed by high performance liquid chromatography-tandem mass spectrometry from dried blood spots. Population PK analysis was performed to determine the volume of distribution and clearance of oral methadone. Methadone plasma concentration-time profiles were simulated from the deduced PK model to optimize the dosing regimen. RESULTS: There was substantial interindividual variability in methadone concentrations. Blood concentrations of methadone were best described by a 1-compartment model with first-order absorption. The population mean estimates (coefficient of variation percentage) for oral clearance and volume of distribution were 8.94 (103%) L/h/70 kg and 177 (133%) L/70 kg, respectively. Optimized dosing strategies were developed based on the simulated PK profiles. We suggest a starting dose of 0.1 mg/kg per dose every 6 hours for most patients requiring pharmacologic treatment of neonatal abstinence syndrome followed by an expedited weaning phase. CONCLUSIONS: The proposed dosing regimen may reduce the cumulative dose of opioid and shorten the length of hospitalization. Future studies should aim to validate the simulated dosing schemes with clinical data and expand our understanding of the between-patient PK variability. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01754324.


Asunto(s)
Analgésicos Opioides/farmacocinética , Metadona/farmacocinética , Síndrome de Abstinencia Neonatal/tratamiento farmacológico , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/uso terapéutico , Cromatografía Liquida , Humanos , Recién Nacido , Espectrometría de Masas , Metadona/administración & dosificación , Metadona/uso terapéutico , Modelos Biológicos , Proyectos Piloto
7.
J Pediatr ; 159(1): 152-154.e3, 2011 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-21592494

RESUMEN

The pharmacokinetics of levetiracetam were determined prospectively in 18 neonates with seizures. Neonates were found to have lower clearance, higher volume of distribution, and a longer half-life as compared with older children and adults. Mild somnolence was the only adverse effect.


Asunto(s)
Anticonvulsivantes/farmacocinética , Piracetam/análogos & derivados , Convulsiones/tratamiento farmacológico , Anticonvulsivantes/uso terapéutico , Peso Corporal , Cromatografía Liquida , Creatinina/sangre , Femenino , Semivida , Humanos , Recién Nacido , Unidades de Cuidado Intensivo Neonatal , Levetiracetam , Masculino , Análisis Multivariante , Piracetam/farmacocinética , Piracetam/uso terapéutico , Estudios Prospectivos , Espectrometría de Masas en Tándem
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