Neonatal Drug Therapy Manual

Ibuprofen

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.

Updated January 26, 2022 - 6:00pm

Alternate Name(s): 
NeoProfen, Pedea (IV form is Special Access Program), Advil, Motrin
Classification: 
Non-Steroidal Anti-Inflammatory
Original Date: 
February 2010
Revised Date: 
February 2021
Indications: 
  • First line treatment of hemodynamically significant patent ductus arteriosus (HS-PDA) in preterm infants less than 29 weeks gestation
  • Treatment of HS-PDA in infants born at or > 29 weeks gestation
Administration: 
  • IV intermittent infusion: over 15 minutes
  • PO
Dosage: 
  • IV/PO  (A maximum of two courses can be administered )
    • 1st course:
      • Initial dose: 10 mg/kg x 1
      • Second and third doses: 5 mg/kg given 24 and 48 hours after first dose respectively
    • 2nd course:
      • Initial dose: 20 mg/kg x 1
      • Second and third doses: 10 mg/kg given 24 and 48 hours after first dose respectively
  • High dose ibuprofen (20 mg/kg x 1 followed by 10 mg/kg given at 24 and 48 hours) can be used initially if the first course of treatment is started during the second week of life.
Side Effects: 
  • CNS: intraventricular hemorrhage, periventricular leukomalacia
  • CVS: hypertension, edema, body fluid retention
  • Endocrine and Metabolic: dilutional hyponatremia, hyper-/hypoglycemia, hyperkalemia
  • GI: abdominal distension, GI bleed, necrotizing enterocolitis, perforation
  • Hematologic:  can inhibit platelet aggregation and may prolong bleeding time, neutropenia
  • Renal: oliguria, fluid retention, hematuria, serum creatinine increase
  • Respiratory: bronchopulmonary dysplasia, pulmonary hemorrhage
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: 

IV:

  • Ibuprofen 10 mg/mL (NeoProfen - Ibuprofen Lysine)
    • Add 2 mL (20 mg) to 3 mL of D5W
    • Final concentration: 4 mg/mL

PO:

  • Oral: Ibuprofen oral suspension
Compatibility: 

- Incompatible: Do not mix with any other drugs or TPN

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 (urine output less than 1 mL/kg/hr over 8 hours, and/or serum Cr > 160 umol/L)
    • Known or suspected NEC
    • Hyperbilirubinemia (relative contraindication)
References: 

- Ohlsson A, Walia R, Shah SS. Ibuprofen for the treatment of patent ductus arteriosus in preterm or low birth weight (or both) infants. Cochrane Database Syst Rev. 2020 11;2:CD003481.

- Mitra S et el. Association of Placebo, Indomethacin, Ibuprofen, and Acetaminophen With Closure of Hemodynamically Significant Patent Ductus Arteriosus in Preterm Infants: A Systematic Review and Meta-analysis. JAMA. 2018 Mar 27;319(12):1221-

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

-  Dani C, Vangi V et al. High-Dose Ibuprofen for Patent Ductus Arteriosus in Extremely Preterm Infants: A Randomized Controlled Study (2011). Clinical Pharmacology & Therapeutics, 91 (4): 590-6

-  Pourarian Sh, Pishva N, Madani A, Rastegari M. Comparison of oral ibuprofen and indomethacin on closure of patent ductus arteriosus in preterm infants.  Eastern Mediterranean Health Journal 2008;14:360-5

-  Salama H, Alsisi A, Al-Rifai H, Shaddad A, Samawal L, Habboub L, Masoud A.  A randomised controlled trial on the use of oral ibuprofen to close patent ductus arteriosus in premature infants.  Journal of Neonatal-Perinatal Medicine 2008;1:153-8

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

-  Volonte M.G., Valora P.D., Cingolani A, Ferrara M. Stability of ibuprofen in injection solutions. Am J Health-Syst Pharm 2005; 62: 630-3

The information contained on this website is provided for informational purposes only, as a guide to assist physicians, nurses and other healthcare providers in deciding on the appropriate care required for a particular patient. At all times, physicians, nurses and other healthcare providers must exercise their independent clinical judgment, based on their knowledge, training and experience, taking into account the specific facts and circumstances of each patient, when deciding on the appropriate course of investigation and/or treatment to recommend in a particular clinical situation.

CHEO has made every effort to ensure that the information contained on this website is as current and accurate as possible. However, changes can occur due to ongoing research and the constant influx of new information. Where possible, hospitals and healthcare practitioners should verify the information before acting on it.

Reliance on any information in this website is at the user's own risk. CHEO is not responsible or liable for any harm, loss or other consequences from the use or misuse of the information on this website.