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

Pediatric Acetaminophen Dosing

The recommended dose of acetaminophen for pediatric patients is 10-15 mg/kg per dose, administered every 4-6 hours, with a maximum daily dose not exceeding 75 mg/kg/day (or 4 grams/day, whichever is less). 1

Standard Dosing by Age and Weight

Infants and Children ≥4 Months

• Single dose: 10-15 mg/kg every 4-6 hours 2, 1
• This dosing range provides optimal antipyretic and analgesic efficacy with maximum temperature reduction occurring approximately 3 hours after administration 1
• Plasma concentrations of 4-18 mg/L are appropriate for therapeutic effect 3

Infants 1-3 Months

• 60-65 mg/kg/day divided into appropriate doses 4
• This age group requires more conservative dosing due to immature hepatic metabolism 4

Neonates (<1 Month)

• 30 mg/kg/day achieves effective therapeutic concentrations 4
• Limited safety data exist for this population, requiring cautious use 4

Alternative Loading Dose Regimen

For situations requiring rapid fever control:

• Loading dose: 25 mg/kg initially 3
• Maintenance: 12.5 mg/kg every 6 hours 3

This approach provides more consistent therapeutic levels while maintaining safety 3.

Maximum Daily Limits

Critical safety threshold: Do not exceed 75 mg/kg/day (or 4 grams/day in adolescents) 5, 6

• Chronic exposures greater than 140 mg/kg/day for several days carry significant risk of serious hepatotoxicity and liver failure 6
• Daily doses above 90 mg/kg/day can cause cumulative hepatic and renal toxicity 4
• The FDA has limited acetaminophen content in prescription combination products to 325 mg per dosage unit to prevent inadvertent overdosing 6

Special Population Adjustments

Hepatic Impairment

Doses should be reduced and dosing intervals extended to minimize hepatotoxicity risk 7, 6

• In patients with liver cirrhosis, a daily dose of 2-3 grams is generally recommended rather than the standard 4 grams 5
• Acetaminophen half-life increases several-fold in cirrhotic patients, necessitating dose reduction 5

Renal Impairment

Standard dosing can generally be used, but monitoring for drug accumulation is recommended in severe cases 7, 6

Administration Considerations

Accurate Measurement

• Use a 3-mL or 5-mL oral syringe for infants and young children to ensure accurate dosing 6
• Parents frequently misdose acetaminophen, with 62% giving inaccurate doses in one study 8
• Caregivers who base dosing on weight rather than age are significantly less likely to misdose (RR 0.71) 8

Formulation Equivalence

• Oral suspension and suppositories at 10-15 mg/kg doses show no significant difference in antipyretic effect, though oral suspension provides more consistent response 3

Common Pitfalls to Avoid

1. Combination product overdosing: When using opioid-acetaminophen combinations, carefully calculate total acetaminophen content to prevent exceeding maximum daily limits 6

2. Age-based dosing errors: Infants <1 year are at highest risk for receiving inaccurate doses (RR 1.40) 8

3. Repeated supratherapeutic ingestions: Multiple doses over 8 hours totaling >200 mg/kg in 24 hours or >150 mg/kg/day for 48+ hours require emergency evaluation 5

4. Inadequate dosing: Many dosing schedules recommend amounts below the therapeutic 10-15 mg/kg range, resulting in inadequate symptom control 2

Alternative Therapy

If acetaminophen is ineffective for fever management, ibuprofen may be considered as second-line treatment 6

Acetaminophen demonstrates equivalent efficacy to aspirin at comparable doses (10-15 mg/kg) but with superior safety profile in children 3.