Neonatal Intensive Care UnitChildren's Hospital


Disclaimer to the On-line Edition
This Manual has been designed for use in the NICU at London Health Sciences Centre (LHSC), London, Ontario, Canada, and represents clinical practice at this institution. The information contained within the Manual may not be applicable to other centres. If users of this Manual are not familiar with a drug, it is recommended that the official monograph be consulted before it is prescribed and administered. Any user of this information is advised that the contributors, Editor and LHSC are not responsible for any errors or omissions, and / or any consequences arising from the use of the information in this Manual.



  • medical management of patent ductus arteriosus


  • a nonsteroidal anti-inflammatory drug (NSAID), indomethacin is an inhibitor of prostaglandin synthesis; it acts on the cyclo-oxygenase pathway
  • the inhibition of prostaglandin E1 synthesis results in constriction of smooth muscle around the ductus
  • absorption of oral indomethacin in neonates is poor (approx. 20%)
  • highly protein bound, but apparently no displacement of bilirubin from albumin occurs at normal serum concentrations
  • in premature neonates the clearance of indomethacin increases with increasing postnatal age
  • in a small number of neonates the mean half life has been reported to be 20-28 hours during the first week of life, and 12-19 hours after the first week
  • indomethacin is more effective early in the infant's course

Side Effects

  • renal dysfunction, as manifested by oliguria, increase in BUN and serum creatinine, and a fall in Glomerular Filtration Rate (GFR); these appear to be reversible
  • GI: bleeding, gastric ulceration, possible reduction in blood flow, association with development of NEC
  • abnormal platelet aggregation
  • hyponatremia (due to suppression of urine volume), hyperkalemia, hypoglycemia


  • infants with proven or suspected infection that is untreated
  • infants who are bleeding
  • thrombocytopenia, coagulation defects, proven or suspected NEC, significant impairment of renal function, known hepatic disease, significant hyperbilirubinemia (>170 umol/L), congenital heart disease
  • evolving intraventricular hemorrhage


  • before administration of the drug the following studies must be done: bilirubin, electrolytes, BUN, creatinine, urinalysis, urine specific gravity, WBC, Hgb, Hct, platelets
  • continue to monitor urine specific gravity, serum Na, infant's weight, and accurate intake and output
  • decrease fluid intake before this medication is given


  • vial containing 1 mg of sterile, lyophilized powder
  • add 2 mL of sterile water for injection to prepare a 0.5 mg/ mL solution


  • 0.2 mg/kg IV q24h
  • a course of therapy is from 1 to 3 doses
  • a 2nd course of 1 to 3 doses may be given
  • administer by IV infusion OVER AT LEAST 20 MINUTES (cerebral blood flow appears to be decreased when indomethacin is given quickly; this does not appear to occur when it is administered over at least 20 minutes)
  • may be given by an RN; a physician does not have to be present in the unit


  1. McEvoy G K (ed): AHFS Drug Information, American Society of Hospital Pharmacists, 1991.
  2. Roberts, RJ: Drug Therapy in Infants, W.B. Saunders, Toronto, 1984.
  3. Colditz P, Murphy D, Rolfe P and Wilkinson AR: Effect of infusion rate of indomethacin on cerebrovascular responses in preterm neonates, Arch Dis Child 1989; 64:8-12.
  4. Krogh CME et al (ed): Compendium of Pharmaceuticals and Specialties, Canadian Pharmaceutical Association, 1992.
  5. Gomella TL (Ed): Neonatology - Management, Procedures, On-Call Problems, Diseases, Drugs, 1992, Appleton and Lange, Norwalk, Connecticut.
  6. Bhatt DR, Furman GI, Reber DJ et al: Neonatal Drug Formulary, 1990-1991, 2nd Edition, Fontana, California 92334.

Last Uploaded: Thursday, 26-May-2011 00:53:40 EDT