45737
document
Clonidine clearance matures rapidly during the early postnatal period : a population pharmacokinetic analysis in newborns with neonatal abstinence syndrome . The population pharmacokinetic ( PK ) profile of oral clonidine was characterized in newborns with neonatal abstinence syndrome , and significant covariates affecting its PK parameters were identified . Plasma clonidine concentration data were obtained from a clinical trial in which 36 newborns , aged 1 to 25 days ( postnatal age , PNA ) and weighing 2.1 to 3.9 kg , were enrolled to take multiple oral doses of clonidine . The population PK model of clonidine was developed by NONMEM , and significant covariates were identified , followed by nonparametric bootstraps ( 2000 replicates ) and simulation experiments . A 1-compartment open linear PK model was chosen to describe plasma concentrations of clonidine , and body weight and PNA were significant covariates for apparent clearance ( CL/F ) as follows : CL/F ( L/h ) = 15.2 × [ body weight ( kg ) /70 ] ( 0.75 ) × [ PNA ( day ) ( 0.441 ) / ( 4.06 ( 0.441 ) + PNA ( day ) ( 0.441 ) ) ] . Furthermore , CL/F of clonidine increased rapidly with PNA during the first month of life after body weight was adjusted . Any optimal dosage regimen for clonidine in term neonates should be based on infant 's age and body weight , and 1.5 µg/kg every 4 hours is proposed starting the second week of life based on the simulation results .
45738
Intervention_Pharmacological
Clonidine
45739
Intervention_Pharmacological
oral clonidine
45740
Intervention_Pharmacological
clonidine
45741
Intervention_Pharmacological
clonidine
45742
Intervention_Pharmacological
clonidine
45743
Outcome_Physical
Clonidine clearance
45744
Outcome_Physical
pharmacokinetic ( PK ) profile
45745
Outcome_Other
Plasma clonidine concentration data
45746
Outcome_Other
PK model of clonidine
45747
Outcome_Other
plasma concentrations of clonidine
45748
Outcome_Physical
body weight and PNA
45749
Outcome_Other
apparent clearance
45750
Participant_Age
newborns
45751
Participant_Condition
neonatal abstinence syndrome
45752
Participant_Age
newborns
45753
Participant_Condition
neonatal abstinence syndrome
45754
Participant_Sample-size
36
45755
Participant_Age
newborns
45756
Participant_Age
1 to 25 days