Paracetamol (Acetaminophen) Dosing for Pediatric Patients
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 mg/kg/day or 5 doses in 24 hours. 1
Standard Dosing by Age and Weight
Weight-based dosing is the most accurate approach for pediatric patients:
- Standard dose: 10-15 mg/kg per dose 1, 2
- Dosing interval: Every 4-6 hours 1
- Maximum daily dose: 60 mg/kg/day 1, 3
- Maximum frequency: Not to exceed 5 doses in 24 hours 1
For optimal efficacy, use 15 mg/kg per dose rather than 10 mg/kg - recent evidence demonstrates that 15 mg/kg is significantly more effective than placebo and at least as effective as NSAIDs, while older studies using subtherapeutic doses of ≤10 mg/kg showed inferior results. 2
Age-Based Dosing (FDA-Approved)
When weight is unknown, the following age-based dosing can be used 4:
- Under 2 years: Consult a doctor 4
- 2 to under 4 years: 5 mL (160 mg) every 4 hours 4
- 4 to under 6 years: 7.5 mL (240 mg) every 4 hours 4
- 6 to under 12 years: 10-15 mL (325 mg) every 4 hours 4
- 12 years and older: 20.3 mL (650 mg) every 4-6 hours 4
Special Population Considerations
Infants Under 3 Months
Paracetamol is the only recommended analgesic for infants under 3 months of age. 1 For term infants, use 3 mg/kg per dose twice daily. 5
Neonates and Preterm Infants
Do not extrapolate doses based on weight from term infants - neonates have prolonged elimination half-lives (55-90 hours vs. 30 hours in adults) due to immature renal function, creating significant risk of accumulation. 5
Hepatic Impairment
Reduce doses and extend intervals to minimize hepatotoxicity risk in children with liver disease. 5, 6
Renal Impairment
Standard dosing can generally be used, but monitor for accumulation. 6
Route of Administration
Oral Administration (Preferred)
Use oral syrup formulation whenever possible - it is absorbed more rapidly and provides more consistent response compared to suppositories. 1, 5
For accurate measurement in infants and young children, use a 3-mL or 5-mL oral syringe rather than household spoons. 5, 6
Rectal Administration
Use rectal paracetamol cautiously due to erratic absorption - some children may receive inadequate analgesia while others risk accumulation with repeated dosing. 1, 5 Consider rectal route only when:
Safety and Toxicity Prevention
Maximum Dose Limits
Never exceed 60 mg/kg/day or 5 doses in 24 hours to prevent hepatotoxicity. 1
Chronic Overdosing Risk
Chronic exposures greater than 140 mg/kg/day for several days carry risk of serious liver toxicity and failure. 6, 3 This is distinct from acute overdose and can occur with repeated supratherapeutic dosing.
Combination Products
Exercise caution with opioid-paracetamol combination products to prevent excess paracetamol dosing. 5, 6 The FDA has limited paracetamol content in prescription combination products to 325 mg per dosage unit. 5, 6
Clinical Efficacy Considerations
Fever Management
Paracetamol improves comfort but does not prevent febrile seizures. 1 For children with history of febrile seizures, prophylactic paracetamol at 15 mg/kg can be given at vaccination and every 4 hours for 24 hours to reduce fever-related discomfort, though this does not prevent seizure recurrence. 1
When Paracetamol is Ineffective
If paracetamol is ineffective for fever or pain management, consider ibuprofen as second-line treatment. 5, 6 Ibuprofen 10 mg/kg every 6-8 hours can be used in children over 6 months. 1
Alternating with Ibuprofen
When both medications are needed, give paracetamol every 4-6 hours and ibuprofen every 6-8 hours, staggering timing so medications are given every 3-4 hours. 1
Common Dosing Errors to Avoid
Many parents underdose or overdose paracetamol - studies show only 61% of children receive appropriate quantities, with 12% receiving overdoses ≥20 mg/kg and 27% receiving underdoses <10 mg/kg. 7 Proper parent education on weight-based dosing and use of accurate measuring devices is essential. 5, 7