Neonatal Drug Therapy Manual

Indomethacin

Disclaimer: Official controlled document is the CHEO and Ottawa Hospital online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
Indocid P.D.A. (IV form is Special Access Program)
Classification: 
Non-Steroidal Anti-Inflammatory
Original Date: 
March 1993
Revised Date: 
November 2019
Indications: 
  • Treatment of hemodynamically significant patent ductus arteriosus (HS-PDA) in infants born at or > 29 weeks gestation
Administration: 
  • IV intermittent infusion: over 20 - 30 minutes
Dosage: 

Patent Ductus Arteriosus, Treatment Dosage:

  • Course of 3 doses given Q12h

 

Age at First Dose

First Dose (mg/kg)

Second Dose (mg/kg)

Third Dose (mg/kg)

 

2 - 7 days

 

0.2

 

0.2

 

 

0.2

 

> 7 days

 

0.2

 

 

0.25

 

 

0.25

NOTE: Use 12-hour dosing if urine output > 1 mL/kg/hour since last dose; use 24 hour dosing interval if urine output is < 1 mL/kg/hour but > 0.6 mL/kg/hour; doses should be withheld if patient has oliguria (urine output < 0.6 mL/kg/hour) or anuria

Side Effects: 
  • CVS: hypertension, edema, body fluid retention
  • Endocrine and metabolic: hyperkalemia, dilutional hyponatremia, hyper-/hypoglycemia
  • GI: vomiting, abdominal distension, GI bleed, necrotizing enterocolitis, perforation
  • Hematologic: can inhibit platelet aggregation and may prolong bleeding time, neutropenia
  • Renal: increase in urea and serum creatinine, transient decrease urine output
Parameters to Monitor: 
  • Serum creatinine and urea, bilirubin, electrolytes, glucose, platelets prior to start of therapy then serially as required
  • Urine output
  • Abdominal distension
  • Signs of bleeding
Reconstitution and Stability: 
  • Indomethacin 1 mg
    • Add 2 mL of 0.9% NaCl. Take 2 mL (1 mg) and add to 8 mL of 0.9% NaCl
    • Final concentration: 0.1 mg/mL
Compatibility: 

- Solutions Compatible: D5W, NS

 

Incompatibility: D7.5W, D10W, TPN, do not mix with any other drugs

Notes: 
  • Contraindications:
    • Active bleeding, coagulation defect
    • Evolving severe intracranial hemorrhage (IVH) (Grades III or IV)
    • Thrombocytopenia (platelet count less than 50 x 109/L)
    • Significant impairment of renal function
    • Known or suspected NEC
    • Hyperbilirubinemia (relative contraindication)
References: 

- Brunner et al. Patent Ductus Arteriosus, Low Platelets, Cyclooxygenase Inhibitors, and Intraventricular Hemorrhage in Very Low Birth Weight Preterm Infants. J Pediatr, 25 Jan 2013 (access www.jpeds.com)

- Fowlie, P. W. and Davis, P.G. (2010), Cochrane Review: Prophylactic Intravenous Indomethacin for Preventing Mortality and Morbidity in Preterm Infants. Evid.-Based Child Health, 5: 416-471. doi: 10.1002/ebch.526

- Kelleher J et al.  Prophylactic Indomethacin and Intestinal Perforation in Extremely Low Birth Weight Infants. Pediatrics. 2014

- Barbara Schmidt, MD et al. Effects of Prophylactic Indomethacin in Extremely Low-Birth-Weight Infants With and Without Adequate Exposure to Antenatal Corticosteroids

- Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook 22th Edition. Hudson: Lexi-Comp Inc.; 2015

 

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