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PEDIATRICS |
From the Departments of Pharmacology (Dr. Sharma, Dr. Garg) and Pediatrics (Dr. Narang), Postgraduate Institute of Medical Education & Research, Chandigarh, India.
Patent ductus arteriosus (PDA) is a frequent complication in premature
infants. So far, intravenous indomethacin is the standard mode of medical
therapy in such patients but carries a risk of frequently occurring side
effects. Ibuprofen, another nonsteroidal anti-inflammatory drug, has also been
shown to be efficacious in closing ductus with lesser adverse effects after
parenteral administration. However, limited data are available on the
pharmacokinetics of intravenous ibuprofen in this population. Nonavailability
of parenteral preparation and lack of information regarding pharmacokinetic
disposition of ibuprofen in this subgroup of the population led the authors to
conduct this pharmacokinetic study with oral ibuprofen. Twenty premature
infants with a gestational age of 30.45 ± 0.33 weeks and a birth weight
of 1262.5 ± 55.4 g (values given as mean ± SEM) admitted to the
neonatal unit were enrolled in this study. Ibuprofen was administered in a
single oral dose of 10 mg/kg between 4 and 72 hours postnatally, and blood
samples were collected through an indwelling vascular catheter at time 0 and
1, 2, 4, 8, 12, and 24 hours. Ibuprofen plasma concentrations were assayed by
high-performance liquid chromatography. There was a large interindividual
variability observed for plasma concentrations, elimination half-life (t
1/2) (15.72 ± 3.76 h), and area under the plasma
concentration-time curve (AUC 0-
) (402.60 79.67 µ g
• h/mL) in these babies. Variables such as gestational age, birth weight,
and sex did not affect ibuprofen pharmacokinetics significantly (p > 0.05).
Moreover, no correlation could be found between elimination half-life and
gestational age (r = 0.02). Ibuprofen pharmacokinetics showed a wide
variability in premature infants. The results of the present study warrant
revising the oral dosage schedule to achieve comparable plasma concentrations
of ibuprofen associated with successful closure of ductus, as reported in
earlier studies.
Key Words: Oral ibuprofen • pediatrics • pharmacokinetics • patent ductus arteriosus • premature infants
Address for reprints: Dr. S. K. Garg, Department of Pharmacology, PGIMER, Chandigarh, India 160012.
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