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

Pediatric Paracetamol Dosing

The recommended dose of paracetamol for children is 10-15 mg/kg per dose, administered every 4-6 hours, with a maximum daily dose of 60-90 mg/kg/day, not exceeding 5 doses in 24 hours for children under 12 years. 1, 2

Standard Dosing by Age and Weight

Age-based dosing from FDA labeling:

• Children 2 to under 4 years: 5 mL (160 mg) every 4 hours, maximum 5 doses per 24 hours 1
• Children 4 to under 6 years: 7.5 mL (240 mg) every 4 hours, maximum 5 doses per 24 hours 1
• Children 6 to under 12 years: 10.15 mL (325 mg) every 4 hours, maximum 5 doses per 24 hours 1
• Children 12 years and older: 20.3 mL (650 mg) every 4-6 hours, maximum 6 doses per 24 hours 1
• Children under 2 years: Consult a physician 1

Weight-based dosing provides more precision: Single doses should range from 10-15 mg/kg administered at 4-hour intervals, with total daily doses not exceeding 60-90 mg/kg/day. 2, 3 The higher end of this range (15 mg/kg per dose, up to 60 mg/kg/day) is used in Australia, while the UK uses 10 mg/kg every 4 hours up to 4 doses daily. 2

Administration Guidelines

Accurate measurement is critical to prevent dosing errors:

• Use a 3-mL or 5-mL oral syringe for infants and young children to ensure precise dosing 4, 5
• Avoid household spoons which lead to inaccurate dosing 4

Special Populations Requiring Dose Adjustment

Hepatic impairment requires significant modification:

• Reduce doses and extend dosing intervals to minimize hepatotoxicity risk 4, 6
• The specific reduction depends on severity of impairment and should be individualized 6

Renal impairment generally allows standard dosing:

• Standard doses can be used in most cases 4, 6
• Monitor for drug accumulation in severe renal impairment 4, 6

Neonates and young infants (under 3 months):

• Limited data exists for this age group 7
• Literature suggests 60-65 mg/kg/day for infants 1-3 months, though pharmacokinetic data may support higher doses 7
• For neonates, 30 mg/kg/day achieves therapeutic concentrations, but further studies are needed 7
• Always consult a physician for children under 2 years 1

Safety Thresholds and Toxicity Prevention

Critical toxicity thresholds to avoid:

• Chronic exposures exceeding 140 mg/kg/day for several days carry serious risk of liver toxicity and failure 4, 2
• Single ingestions of more than 10 times the recommended dose are potentially hepatotoxic 2
• The maximum safe daily dose is generally considered 90-95 mg/kg/day 7

Common pitfall - combination products:

• When using opioid-paracetamol combination products, carefully calculate total paracetamol dose to prevent inadvertent overdosing 4
• FDA has limited paracetamol content in prescription combinations to 325 mg per dosage unit 4

Dosing errors are common in practice:

• Studies show 43% of children receive supratherapeutic doses (>15 mg/kg/dose), with risk increasing in children over 3 years 8
• 17% of prescriptions exceed 95 mg/kg/day in hospital settings, though actual administration is lower due to nursing and pharmacy oversight 7
• Caregiver knowledge of weight-appropriate dosing is poor, with only 1% able to calculate correct doses 8

Alternative Treatment

If paracetamol is ineffective for fever management:

• Consider ibuprofen as second-line treatment 4, 5
• Ibuprofen has less clinical experience in children compared to paracetamol and remains second-line 2