What is the recommended dose of paracetamol (acetaminophen) for pediatric patients of different ages and weights?

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Paracetamol (Acetaminophen) Dosing for Children

The recommended dose of paracetamol for children is 10-15 mg/kg per dose, given every 4-6 hours, with a maximum daily dose of 60 mg/kg/day (not to exceed 5 doses in 24 hours). 1, 2

Standard Dosing by Weight

Weight-based dosing is more accurate than age-based dosing and should be prioritized. 1, 3

  • Standard single dose: 10-15 mg/kg per dose 1, 4, 5
  • Dosing interval: Every 4-6 hours 1, 2
  • Maximum daily dose: 60 mg/kg/day 1, 6
  • Maximum number of doses: Not to exceed 5 doses in 24 hours 2

The 15 mg/kg dose is more effective than 10 mg/kg doses and shows equivalent efficacy to NSAIDs while maintaining excellent tolerability. 5

Age-Based Dosing (When Weight Unknown)

When weight is unavailable, the FDA-approved age-based dosing can be used: 2

  • Ages 2 to under 4 years: 5 mL (160 mg) every 4 hours
  • Ages 4 to under 6 years: 7.5 mL (240 mg) every 4 hours
  • Ages 6 to under 12 years: 10.15 mL (325 mg) every 4 hours
  • Ages 12 years and over: 20.3 mL (650 mg) every 4-6 hours (not to exceed 6 doses in 24 hours)
  • Under 2 years: Consult a doctor 2

Special Populations

Infants Under 3 Months

  • Paracetamol is the only recommended analgesic in this age group 1
  • Dose: 15 mg/kg if weight is less than 10 kg 1
  • Limited evidence exists for neonates; 30 mg/kg/day achieves therapeutic concentrations, though further studies are needed 7
  • For infants 1-3 months, 60-65 mg/kg/day is suggested, though pharmacokinetic data may favor higher doses 7

Post-Vaccination Fever

  • Can be given at time of vaccination and every 4 hours for 24 hours 1

Children with History of Febrile Seizures

  • Prophylactic dose of 15 mg/kg every 4 hours for 24 hours can reduce fever risk, though it does not prevent febrile seizures themselves 1

Route of Administration

Oral syrup is strongly preferred over rectal suppositories due to more rapid and consistent absorption. 1

Rectal Administration

  • Should be used cautiously due to erratic absorption 1
  • Consider only when child is actively vomiting or in perioperative situations where oral intake is restricted 1
  • Risk of inadequate analgesia or accumulation with repeated dosing 1

Critical Safety Considerations

Maximum Dose Limits

  • Never exceed 60 mg/kg/day or 5 doses in 24 hours 1, 2
  • Single ingestions exceeding 10 times the recommended dose are potentially toxic 6
  • Chronic exposures greater than 140 mg/kg/day for several days carry risk of serious hepatotoxicity 6

Common Prescribing Errors

  • Many dosing schedules recommend inadequate amounts (≤10 mg/kg), which are less effective than NSAIDs 4, 5
  • 17% of prescriptions may exceed 95 mg/kg/day, though actual administration is lower due to pharmacy and nursing oversight 7
  • Prescriptions should clearly state: daily dose, number of divided doses, and child's weight 3

Pain Management Context

  • Paracetamol is appropriate for mild-to-moderate pain 1
  • Should not be used alone for severe pain; consider as adjunct only 1
  • Provides significant additive analgesic effect when combined with opiates for severe pain 6

Clinical Efficacy

When dosed at 15 mg/kg, paracetamol is: 5

  • Significantly more effective than placebo
  • At least as effective as NSAIDs (ibuprofen, ketoprofen)
  • Shows lower risk of adverse events compared to NSAIDs with repetitive dosing
  • Has tolerability profile similar to placebo for short-term use

References

Guideline

Pediatric Acetaminophen and Ibuprofen Dosing Guidelines

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

[Amoxicillin and paracetamol dosing in children: playing safe].

Nederlands tijdschrift voor geneeskunde, 2016

Research

Pediatric dosing of acetaminophen.

Pediatric pharmacology (New York, N.Y.), 1983

Research

Paracetamol efficacy and safety in children: the first 40 years.

American journal of therapeutics, 2000

Research

Paracetamol prescribing habits in a children's hospital.

The New Zealand medical journal, 1996

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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