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The pharmacokinetic and pharmacodynamic effects of indomethacin were studied in 18 prematures with patent ductus arteriosus, treated either enterally (group I, n = 7), or intravenously (group II, n = 11). A definitive closure assessed by echocardiography was observed in 13 cases (72%), and it was only transient in 4 cases (21%). Assisted ventilation was discontinued between 1 and 6 days following therapy in 14 cases. In most cases, indomethacin induced a significant reduction of diuresis but the plasma creatinine level increased above 15 mg/l in 3 cases only. The elimination half life of indomethacin (t 1/2 beta), of 40.3 +/- 12.2 hours in group I and 33.9 +/- 11.7 hours in group II, is increased as compared with adults. The difference of the surface under the curve (AUC O leads to 24 h, ng.ml-1.h-1) between the infants who presented complete or transient closure, suggests a relationship between the biodisponibility of the drug and the effect on patent ductus arteriosus. Treatment with indomethacin is an interesting alternative to surgical ligation in prematures with patent ductus arteriosus. Because of its side effects, especially on the kidneys, it is recommended to use this treatment only in intensive care units. The intravenous route seems to be better than the enteral route.