Paracetamol (Acetaminophen) Dosing in Children
The recommended paracetamol dose for children is 15 mg/kg per dose given every 4-6 hours, with a maximum daily dose of 60 mg/kg/day, and should not be used in neonates younger than 2 months without specific guidance. 1
Standard Dosing Regimen
Per-Dose Administration:
- 15 mg/kg per dose is the optimal therapeutic dose for both fever and pain management 1, 2
- Administer every 4-6 hours as needed 1
- Maximum of 5 doses in 24 hours 1
Maximum Daily Limits:
- 60 mg/kg/day total - never exceed this threshold 1, 2, 3
- This maximum applies regardless of number of doses given 1
Age-Specific Restrictions and Dosing
Neonates and Young Infants:
- Avoid use in neonates under 2 months unless specifically indicated, as there are no established dosing guidelines for this age group 4
- For infants under 3 months when treatment is necessary: 15 mg/kg per dose if weight is less than 10 kg 1
- For infants 1-3 months: 60-65 mg/kg/day has been suggested in literature, though pharmacokinetic data may support higher doses 4
Children 4 months and older:
Critical Safety Considerations
Hepatotoxicity Risk:
- Single ingestions exceeding 10 times the recommended dose are potentially hepatotoxic 5
- Chronic overdosing at >140 mg/kg/day for several consecutive days carries risk of serious liver toxicity and potential liver failure 5
- Children with pre-existing liver disease should not receive paracetamol 3
- Exercise extreme caution with concurrent hepatotoxic medications 3
Dosing Errors to Avoid:
- Many older dosing schedules recommend inadequate amounts (≤10 mg/kg), which are subtherapeutic 2, 6
- Prescriptions exceeding 95 mg/kg/day have been documented in 17% of cases in hospital audits, though most were not administered due to nursing/pharmacy oversight 4
- Weight-based dosing is more accurate than age-based dosing for preventing under- or overdosing 6
Route of Administration
Oral (Preferred):
- Oral syrup formulation is absorbed more rapidly and provides more consistent response than rectal suppositories 1
- Effervescent tablets provide even faster absorption and onset of action compared to conventional tablets 3
Rectal (Use Cautiously):
- Rectal administration has slow and irregular absorption 3
- The American Academy of Pediatrics recommends rectal acetaminophen be used cautiously because of erratic absorption 1
- Some children may receive inadequate analgesia while others risk accumulation with repeated dosing 1
- Consider rectal route only for children actively vomiting or in perioperative situations where oral intake is restricted 1
Alternative: Ibuprofen Dosing
Standard Ibuprofen Regimen:
- 10 mg/kg per dose given every 6-8 hours 1
- Not recommended for infants under 6 months 1
- Available oral or rectal routes 1
Alternating Paracetamol and Ibuprofen:
- Give paracetamol every 4-6 hours and ibuprofen every 6-8 hours 1
- Stagger timing so medications are given every 3-4 hours if both are needed 1
- This approach can be used for refractory fever or pain, though paracetamol alone is first-line 1
Comparative Efficacy
Paracetamol vs NSAIDs:
- At 15 mg/kg dosing, paracetamol is significantly more effective than placebo and at least as effective as NSAIDs (ibuprofen, ketoprofen) 2
- Older studies using subtherapeutic doses of ≤10 mg/kg showed paracetamol was less effective than NSAIDs, but this reflects inadequate dosing rather than true drug efficacy 2
- When used at repetitive doses for consecutive days, paracetamol shows lower risk of adverse events compared to NSAIDs 2
- Unlike NSAIDs, paracetamol is indicated for use in children of all ages (though caution in neonates <2 months) 2
Special Clinical Situations
Febrile Seizure History:
- Paracetamol 15 mg/kg can be given prophylactically every 4 hours for 24 hours to reduce fever risk, though it does not prevent febrile seizures themselves 1
Post-Vaccination Fever:
- Can be given at time of vaccination and every 4 hours for 24 hours for fever prevention 1
Renal Insufficiency: