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Serum indomethacin concentrations after intravenous administration to preterm infants with patent ductus arteriosus
Insights
Intravenous indomethacin effectively closes the patent ductus arteriosus (PDA) in preterm infants, achieving therapeutic serum concentrations. Repeated dosing may be necessary to maintain efficacy and manage potential side effects.
Area of Science:
- Neonatal Medicine
- Pediatric Pharmacology
Background:
- Patent ductus arteriosus (PDA) is a common condition in preterm infants.
- Indomethacin is a frequently used medication to treat PDA.
Purpose of the Study:
- To evaluate the efficacy and pharmacokinetics of intravenous indomethacin for PDA closure in preterm infants.
- To assess the safety profile of this treatment regimen.
Main Methods:
- Six preterm infants with PDA received intravenous indomethacin (0.2 mg/kg).
- Auscultatory and echocardiographic assessments were used to determine duct closure.
- Serum indomethacin concentrations and half-life were measured.
- Adverse events were monitored.
Main Results:
- Duct closure occurred in 2 infants, partial closure in 2, and no effect in 2.
- Mean serum indomethacin concentrations peaked shortly after injection and declined over 24 hours.
- The mean serum half-life was 20 hours.
- Common side effects included hyponatremia, decreased urinary output, and weight gain. One infant experienced thrombocytopenia and gastrointestinal hemorrhage.
Conclusions:
- Intravenous indomethacin at 0.2 mg/kg achieves adequate serum concentrations in preterm infants.
- A repeated dosing schedule (0.2 mg/kg at 6 hours, 0.1 mg/kg at 24 hours) is recommended to maintain therapeutic levels.
- Careful monitoring for side effects is essential.
Abstract:
Six preterm infants with PDA received 14 treatments with indomethacin 0.2 mg/kg intravenously. Auscultatory and echocardiographic assessment indicated closure of the duct in 2, partial closure in 2, and no effect in 2 infants. The mean serum concentration of indomethacin was: 15 min after the first injection 1 314 ng/ml, after 1 hour 970 ng/ml, after 6 hours 718 ng/ml, and after 24 hours 388 ng/ml. The mean half-life of indomethacin in the serum was 20 hours (range 9-50 hours). Side effects in all infants were hyponatraemia, decreased urinary output, decreased urinary sodium excretion, and weight gain. One infant had transient thrombocytopenia and gastrointestinal haemorrhage. By intravenous administration of indomethacin in a dose of 0.2 mg/kg to preterm infants a sufficiently high serum concentration is obtained shortly after the injection. To maintain a high serum concentration for a longer period it is recommended to give a second dose of 0.2 mg/kg after 6 hours and if necessary a third dose of 0.1 mg/kg 24 hours after the first dose.