- Indomethacin may mask the usual signs and symptoms of infection; use extreme caution in the presence of existing controlled infection
- Discontinue the drug if clinical signs/symptoms consistent with liver disease develop in the neonates or if systemic manifestations occur
- Indomethacin injections may inhibit platelet aggregation and prolong bleeding time in some patients; closely monitor neonates for signs of bleeding
- Minor GI bleeding, noticed on chemical detection of blood in the stool, have been commonly reported during therapy in neonates
- Intraventricular hemorrhage may occur in neonates due to inhibition of platelet aggregation
- Therapy may cause marked reduction in urine output along with increased BUN and creatinine, and reductions in GFR and creatinine clearance; these effects disappear on discontinuation of therapy in most neonates
- Indomethacin for injection may precipitate renal insufficiency, including acute renal failure in neonates with other conditions that may adversely affect renal function
- In preterm infants, IV indomethacin may significantly reduce water excretion resulting in severe hyponatremia; monitor renal function and serum electrolytes during therapy
- Carefully inject the drug to avoid extravascular injection or leakage as the solution may be irritating to the tissue
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Fluid retention
- Sepsis
- Dehydration
Pregnancy Category: Not indicated in pregnancy
Breastfeeding: Acceptable in nursing mothers because of low levels of indomethacin in breastmilk and therapeutic administration directly to infants; but an alternate drug may be preferred if more information is available about the safe use of that agent while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 9 March 2011).
