Neonatal Drug Therapy Manual

Acetaminophen

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): 
Tylenol, Tempra
Classification: 
Analgesic, antipyretic
Original Date: 
June 1996
Revised Date: 
March 2020
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.
Administration: 
  • PO
  • PR*
  • IV intermittent infusion: over 15 minutes.
Dosage: 
  • Relief of pain or elevated temperature.
    • PO: 10 - 15 mg/kg/dose Q4 - 6h PRN
    • PR: 20 mg/kg/dose Q4 - 6h PRN                                                                   
    • Maximum daily dose = 60 mg/kg/day

 

  • 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
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 doses administered rectally, the oral drops (Tempra oral drops) will be dispensed patient specific by pharmacy as the oral suspension should not be used.

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

 

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