Paracetamol (Acetaminophen) Pediatric 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 75 mg/kg/day (not to exceed 4 grams/day in adolescents). 1, 2
Standard Dosing by Age and Weight
Oral Administration (FDA-Approved Dosing)
- Children under 2 years: Consult a physician 1
- Children 2 to under 4 years: 5 mL (160 mg) every 4 hours, not to exceed 5 doses in 24 hours 1
- Children 4 to under 6 years: 7.5 mL (240 mg) every 4 hours, not to exceed 5 doses in 24 hours 1
- Children 6 to under 12 years: 10-15 mL (325 mg) every 4 hours, not to exceed 5 doses in 24 hours 1
- Children 12 years and older: 20.3 mL (650 mg) every 4-6 hours, not to exceed 6 doses in 24 hours 1
Weight-Based Dosing (Preferred for Accuracy)
For optimal efficacy, use 15 mg/kg per dose for both fever and pain management, as this dose is significantly more effective than lower doses while maintaining safety. 2 The traditional 10 mg/kg dosing is less effective than NSAIDs, whereas 15 mg/kg demonstrates equivalent efficacy to NSAIDs with superior safety 2, 3
- Single dose range: 10-15 mg/kg 4, 2
- Dosing interval: Every 4-6 hours 1, 4
- Maximum daily dose: 75 mg/kg/day (reduced from previous recommendations of 90 mg/kg/day due to safety concerns) 5
Critical Dosing Considerations
Loading Dose Strategy
For acute pain or fever, consider an initial loading dose of 20-25 mg/kg, followed by maintenance doses of 12.5-15 mg/kg every 6 hours 6. This achieves therapeutic plasma concentrations (4-18 mg/L) more rapidly 6
Special Populations
Overweight and obese children: Calculate doses based on ideal body weight (IBW) for height, not actual body weight, to prevent inadvertent overdosing and hepatotoxicity 5
Hepatic impairment: Reduce doses and extend dosing intervals to minimize hepatotoxicity risk 7
Renal impairment: Standard dosing can generally be used, but monitor for accumulation in severe cases 7
Administration Technique
Use an appropriate measuring device such as a 3-mL or 5-mL oral syringe for accurate measurement in infants and young children to prevent dosing errors 8
Safety Thresholds and Toxicity
- Potentially toxic single dose: >150 mg/kg 5
- Chronic overdosing risk: Exposures >140 mg/kg/day for several consecutive days carry risk of serious hepatotoxicity 3
- Hepatocellular necrosis threshold: Doses totaling 150 mg/kg may cause severe hepatocellular necrosis, but adverse effects can occur with doses as low as 75 mg/kg in 24 hours in some children 5
Route-Specific Considerations
Oral suspension provides more consistent absorption and response compared to rectal suppositories at equivalent doses (10-15 mg/kg) 6
Intravenous paracetamol: Follow BNF for Children dosing guidelines, prescribe IV route independently from oral/rectal routes, and review patients after 48 hours for switch to oral route 5
Common Pitfalls to Avoid
- Avoid prescribing combined IV/PO routes simultaneously without clear documentation, as this increases overdose risk 5
- Always document patient weight on prescription charts; height documentation enables IBW calculation for overweight children 5
- Do not use subtherapeutic doses (<10 mg/kg), as these show inferior efficacy compared to NSAIDs 2
- Avoid prolonged IV use beyond 48 hours without clinical justification, as oral route is equally effective and more cost-effective 5
Comparative Efficacy
Paracetamol 15 mg/kg demonstrates equivalent antipyretic and analgesic efficacy to NSAIDs (ibuprofen, ketoprofen) but with lower risk of adverse events during repetitive dosing over consecutive days 2. Unlike NSAIDs, paracetamol is indicated for use in children of all ages 2