Neonatal Drug Therapy Manual

Acetaminophen

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Updated February 21, 2024 - 6:38pm

Alternate Name(s): 
Tylenol, Tempra
Classification: 
Analgesic, antipyretic
Original Date: 
June 1996
Revised Date: 
January 2023
Indications: 
  • Relief of pain or elevated temperature.
  • Closure of patent ductus arteriosus (PDA)  when usual medication management with Ibuprofen or Indomethacin is ineffective or contraindicated.
  • Post-operative pain care
Administration: 
  • PO
  • PR*
  • IV intermittent infusion: over 15 minutes.
Dosage: 
  • General relief of pain, and for elevated temperature:
    • PO: 10 - 15 mg/kg/dose Q4 - 6h PRN
    • PR: 20 mg/kg/dose Q4 - 6h PRN                                                                   
    • Recommended maximum daily dose = 60 mg/kg/day ​for < 37 weeks CGA; 75 mg/kg/day > 37 weeks CGA
  • Closure of patent ductus arteriosus (PDA) when usual medication management with Ibuprofen or Indomethacin is ineffective or contraindicated
    • 15 mg/kg/dose PO/IV/PR Q6h x 3 to 7 days.

 

  • CHEO Post-operative Pain Management in the NICU Protocol (start dosing 30 minutes prior to procedure):
PO
CGA 28-32 weeks 10-12 mg/kg/dose Q 6-8h, max 40 mg/kg/day
CGA> 32-37 weeks 10-15 mg/kg/dose Q6h, max 60 mg/kg/day
CGA> 37 weeks 10-15 mg/kg/dose Q 4-6h, max 75 mg/kg/day
PR
CGA 30-33 weeks 20 mg/kg/dose Q12h, max 40 mg/kg/day
CGA 34-39 weeks 25 mg/kg/dose Q8h, max 75 mg/kg/day
CGA> 40 weeks- infant 30 mg /kg/dose Q6h, max 120 mg/kg/day
IV
CGA> 25-37 weeks 7.5-10 mg/kg/dose Q6-8h, (see PO for suggested cga max's).
CGA > 37 weeks 10-15 mg/kg/dose Q6-8h, max 60 mg/kg/day.
Side Effects: 
  •   Hematologic: neutropenia, thrombocytopenia, leukopenia
  • Hepatic: liver toxicity with excessive doses

“Pediatric Considerations: ACETAMINOPHEN INJECTION contains low molecular weight povidone (povidone K12) and there is limited data supporting its safe use in neonates and infants. Povidone is an inactive compound which is not metabolized prior to its renal elimination, probably primarily through glomerular filtration. Although the potential for povidone accumulation is unknown, there is a possibility in the neonates and very young children where the glomerular filtration is immature."

Parameters to Monitor: 
  • Assess for signs of pain,
  • Temperature
  • Liver function tests when given for PDA closure.
Reconstitution and Stability: 
  • Acetaminophen 10 mg/mL
    • Available as acetaminophen 10 mg/mL - prefilled syringe prepared by pharmacy
    • Final concentration: 10 mg/mL
Compatibility: 

- Solutions Compatible: D5W, 0.9%NaCl

- Y-site Compatible: clindamycin, dexamethasone, fentanyl, heparin, hydrocortisone, hydromorphone, lorazepam, midazolam, morphine, potassium chloride, SMOF, TPN, vancomycin

  • Incompatible: acyclovir, diazepam
Notes: 

* For PR doses that can't be given using suppositories, the oral drops (Sugar-Free oral drops) will be dispensed patient specific by pharmacy as the regular oral suspension should not be used. To note, some brands might have dyes in them (i.e. red dye).

  • Dosing recommendations should not be exceeded in the first few days of life, and the dose should be reduced in the presence of unconjugated hyperbilirubinaemia.
References: 

- Ohlsson A,　Shah PS. Paracetamol　(acetaminophen) for patent ductus arteriosus in preterm or low birth weight infants. Cochrane Database Syst Rev.　2018 Apr 6;4:CD010061.

- Bardanzellu F;　Neroni P. Paracetamol in Patent Ductus Arteriosus Treatment: Efficacious and Safe? BioMed Research International. 2017:1438038, 2017.

- American Society on Health-System Pharmacists (ASHP). Handbook on Injectable Drugs. 19th Edition. Bethesda: American Society of Health-System Pharmacists; 2017.

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

- Anderson BJ, Allegaert K. Intravenous neonatal paracetamol dosing: the magic of 10 days. Paediatr Anaesth. 2009 Apr;19(4):289-95. 

- Mian P, Knibbe CA, Tibboel D, Allegaert K. What is the dose of intravenous paracetamol for pain relief in neonates? Arch Dis Child. 2017 Jul;102(7):649-650. doi: 10.1136/archdischild-2017-312870.

- PEDIATRIC PHARMACOTHERAPY: A Monthly Newsletter for Health Care Professionals from the
University of Virginia Children’s Hospital. Volume 17 Number 4 April 2011. "Intravenous Acetaminophen Use in Infants and Children." Marcia L. Buck, Pharm.D., FCCP, FPPAG.

- Flint RB, Roofthooft DW, van Rongen A, van Lingen RA, van den Anker JN, van Dijk M, Allegaert K, Tibboel D, Knibbe CAJ, Simons SHP. Exposure to acetaminophen and all its metabolites upon 10, 15, and 20 mg/kg intravenous acetaminophen in very-preterm infants. Pediatr Res. 2017 Oct;82(4):678-684. doi: 10.1038/pr.2017.129.

- Palmer GM, Atkins M, Anderson BJ, Smith KR, Culnane TJ, McNally CM, Perkins EJ, Chalkiadis GA, Hunt RW. I.V. acetaminophen pharmacokinetics in neonates after multiple doses. Br J Anaesth. 2008 Oct;101(4):523-30. doi: 10.1093/bja/aen208.

-The British National Formulary Handbook

 

 

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