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

Pediatric Paracetamol (Acetaminophen) Dosing

The recommended oral dose of paracetamol for children is 10-15 mg/kg every 4-6 hours, with a maximum daily dose of 60-75 mg/kg/day, using weight-based dosing with an appropriate measuring device such as a 3-5 mL oral syringe. 1, 2, 3

Weight-Based Dosing Guidelines

Oral Administration

• Single dose: 10-15 mg/kg every 4-6 hours 3, 4, 5
• Maximum daily dose: 60-75 mg/kg/day (not to exceed 4 g/day in adolescents) 3, 5, 6
• Dosing interval: Every 4-6 hours 2, 3

Age-Based Dosing (FDA-Approved)

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

Administration Considerations

Use a calibrated 3-5 mL oral syringe for accurate measurement in infants and young children to prevent dosing errors. 7, 1

Route Selection

• Oral route is preferred for standard dosing 2, 5
• Rectal administration has slower and more irregular absorption compared to oral 5
• Intravenous paracetamol should be prescribed independently from oral/rectal routes and reviewed at 48 hours for potential switch to oral 6

Special Populations

Overweight and Obese Children

Calculate doses based on ideal body weight (IBW) rather than actual body weight to prevent inadvertent overdosing. 6

• Use lean body mass and ideal weight for height when determining appropriate dosing 6
• This prevents potentially toxic doses in children with elevated BMI 6

Hepatic Impairment

Reduce doses and extend dosing intervals in children with hepatic insufficiency to minimize hepatotoxicity risk. 7

• Paracetamol is contraindicated in hepatic insufficiency 5

Renal Impairment

Standard dosing can generally be used, but monitor for drug accumulation 7

Safety and Toxicity Prevention

Critical Toxicity Thresholds

• Acute overdose: Single ingestions >150 mg/kg may cause severe hepatocellular necrosis 6
• Chronic toxicity: Exposures >140 mg/kg/day for several days carry risk of serious liver toxicity and failure 7, 3
• Lower threshold: Some children may experience adverse effects with doses as low as 75 mg/kg in 24 hours 6

Combination Products

Exercise extreme caution with opioid-acetaminophen combination products to prevent excess acetaminophen dosing. 7

• FDA limits acetaminophen content in prescription combinations to 325 mg per dosage unit 7

Clinical Efficacy Considerations

If paracetamol is ineffective for fever or pain management, consider ibuprofen as second-line treatment. 7, 1

• Paracetamol remains first-line choice for both fever and pain in children 3
• When used in recommended doses, it has few side effects and is remarkably well tolerated 3
• Paracetamol offers significant additive analgesic effect when combined with opiates for severe pain 3

Common Pitfalls to Avoid

• Failure to document weight and height: Weight should be documented on all prescriptions; height is needed to calculate IBW in overweight children 6
• Prescribing IV/PO routes together: These should be prescribed independently to prevent double-dosing 6
• Prolonged IV use: Review IV paracetamol at 48 hours for switch to oral route when appropriate 6
• Using inadequate measuring devices: Household spoons are inaccurate; always use calibrated syringes 7, 1