Pharmacokinetics and clinical efficacy of indomethacin in premature infants with patent ductus arteriosus
Regazzi, M.B.; Rondanelli, R.; Vidale, E.; Chirico, G.; Rondini, G.; Chiara, A.; Piccolo, A.
International Journal of Clinical Pharmacology Research 4(2): 109-112
1984
ISSN/ISBN: 0251-1649 PMID: 6469435 Document Number: 240818
Despite a conderable amount of investigation, controversy continues concerning the use of indomethacin in inducing the closure of patent ductus arteriosus [PDA]. This controversy may be attributable to differences in dosage, route of administration, postnatal age at treatment and the variable pharmacokinetics of the drug in premature infants. The pharmacokinetics and clinical efficacy of i.v. administered indomethacin in 5 premature infants with PDA were evaluated. There was considerable intersubject variability in the half life of elimination (63.1 .+-. 38 h). This variability was mainly due to clearance (0.0086 .+-. 0.0069 l/h per kg) rather than to distribution volume variability (0.54 .+-. 0.27 l/kg). A reduction of half life was observed after the second dose, probably due to a maturation process. A permanent closure of the ductus was obtained in 2 patients after the first dose and in 2 patients after the second dose. The side effects observed in the infants were transient and no long-term complication was attributable to this drug.