What is the recommended dose of paracetamol (acetaminophen) for pediatric patients?

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Paracetamol (Acetaminophen) Dosing for Children

For children 4 months and older, use 10-15 mg/kg per dose every 4-6 hours, not exceeding 60-75 mg/kg/day or 5 doses in 24 hours. 1, 2, 3, 4, 5

Standard Dosing by Age and Weight

Oral Dosing Guidelines

Children 2 to under 4 years:

  • 5 mL (160 mg) every 4 hours
  • Maximum 5 doses in 24 hours 3

Children 4 to under 6 years:

  • 7.5 mL (240 mg) every 4 hours
  • Maximum 5 doses in 24 hours 3

Children 6 to under 12 years:

  • 10.15 mL (325 mg) every 4 hours
  • Maximum 5 doses in 24 hours 3

Children 12 years and older:

  • 20.3 mL (650 mg) every 4-6 hours
  • Maximum 6 doses in 24 hours 3

Weight-Based Dosing Algorithm

For precise dosing in all pediatric patients 4 months and older:

  • Single dose: 10-15 mg/kg 6, 5
  • Dosing interval: Every 4-6 hours 4, 5
  • Maximum daily dose: 60-75 mg/kg/day (not to exceed 4 grams/day in adolescents) 4, 5
  • Maximum frequency: 4-5 doses per 24 hours 3, 4

The 15 mg/kg dose every 4 hours (up to 60 mg/kg/day total) is commonly used in Australia and provides optimal analgesic and antipyretic effect 5. The UK uses 10 mg/kg every 4 hours up to 4 doses daily 4.

Special Populations

Infants Under 4 Months

For term infants 1-3 months:

  • 3 mg/kg per dose twice daily 2
  • Literature suggests 60-65 mg/kg/day is safe, though pharmacokinetic data may support higher doses 7

For neonates under 2 weeks:

  • 30 mg/kg/day achieves therapeutic concentrations 7
  • Do not extrapolate weight-based dosing from older infants due to immature renal function and prolonged elimination half-life (55-90 hours vs. 30 hours in adults) 2

For children under 2 years (general):

  • Consult a physician for specific dosing 3

Hepatic Impairment

Reduce doses and extend dosing intervals to minimize hepatotoxicity risk 1, 2. Paracetamol is contraindicated in hepatic insufficiency 5.

Renal Impairment

Standard dosing can generally be used, but monitor for drug accumulation 1. No dose reduction is typically necessary even with reduced clearance 5.

Administration Technique

Use precise measuring devices:

  • 3-mL or 5-mL oral syringes for infants and young children 1, 2, 8
  • This prevents dosing errors that commonly occur with household spoons or imprecise measuring tools 2

Safety and Toxicity Prevention

Acute Overdose Thresholds

Single ingestions exceeding 10 times the recommended dose are potentially hepatotoxic 4.

Chronic Overdose Risk

Chronic exposures greater than 140 mg/kg/day for several days carry serious risk of liver toxicity and failure 1, 4. Even doses exceeding 90-95 mg/kg/day can cause cumulative hepatic and renal toxicity 7.

Combination Products

Exercise caution with opioid-acetaminophen combination products to prevent excess paracetamol dosing 1, 2. The FDA has limited paracetamol content in prescription combination products to 325 mg per dosage unit 1, 2.

Clinical Efficacy Considerations

If paracetamol is ineffective for fever or pain management, consider ibuprofen as second-line treatment 1, 2, 8. Paracetamol has equivalent efficacy to other analgesic-antipyretics in clinical studies and remains the first-choice over-the-counter treatment for analgesia and antipyresis in children 4, 6.

Common Prescribing Pitfalls

Many dosing schedules recommend inadequate amounts of paracetamol 6. In one hospital audit, 17% of prescriptions exceeded 95 mg/kg/day, though only 3% of children actually received these excessive doses due to pharmacy and nursing oversight 7. Medical staff are frequently unsure of safe dosing regimens, particularly for younger age groups 7.

Key pitfall: Prescribing "as needed" without clear maximum daily limits can lead to cumulative toxicity over multiple days 7.

References

Guideline

Acetaminophen Dosing and Administration in Children

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Paracetamol Dosage in Children

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2026

Research

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

American journal of therapeutics, 2000

Research

Pediatric dosing of acetaminophen.

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

Research

Paracetamol prescribing habits in a children's hospital.

The New Zealand medical journal, 1996

Guideline

Paracetamol Dosing and Administration in Children

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

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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