What is the recommended dosing of Paracetamol (Acetaminophen) in pediatric patients?

Paracetamol (Acetaminophen) Dosing in Pediatric Patients

The recommended dose of paracetamol in children is 10-15 mg/kg per dose, administered every 4-6 hours, with a maximum daily dose not exceeding 60-75 mg/kg/day or 4 grams/day (whichever is lower). 1, 2

Age and Weight-Based Dosing Guidelines

Standard Dosing by Age (FDA-Approved)

• Children under 2 years: Consult a physician for appropriate dosing 1
• Children 2 to under 4 years: 5 mL (160 mg) every 4 hours, not exceeding 5 doses in 24 hours 1
• Children 4 to under 6 years: 7.5 mL (240 mg) every 4 hours, not exceeding 5 doses in 24 hours 1
• Children 6 to under 12 years: 10-15 mL (325 mg) every 4 hours, not exceeding 5 doses in 24 hours 1
• Children 12 years and older: 20.3 mL (650 mg) every 4-6 hours, not exceeding 6 doses in 24 hours 1

Weight-Based Dosing (Preferred Method)

Single dose range: 10-15 mg/kg every 4-6 hours 2, 3

• The 10-15 mg/kg range represents the most evidence-based approach, with 15 mg/kg providing more consistent antipyretic and analgesic effects than 10 mg/kg 2, 4
• Doses below 10 mg/kg have been shown to have minimal antipyretic effect 4
• A loading dose of 25 mg/kg followed by maintenance doses of 12.5 mg/kg every 6 hours has been proposed for optimal therapeutic effect 4

Maximum Daily Dosing Limits

Critical safety threshold: Do not exceed 90-95 mg/kg/day 5

• The maximum safe daily dose varies by region: 60 mg/kg/day (UK, Australia) to 65 mg/kg/day (USA) 2, 3
• Doses exceeding 140 mg/kg/day for several days carry significant risk of hepatotoxicity 3
• Single acute ingestions exceeding 150 mg/kg (or 10 times the recommended dose) are potentially hepatotoxic 3

Special Populations

Infants Under 3 Months

• Paracetamol is the only recommended analgesic for this age group 6
• Dosing should be individualized with physician consultation due to limited pharmacokinetic data 1, 5
• Literature suggests 30 mg/kg/day achieves therapeutic concentrations in neonates, though further studies are needed 5

Infants 1-3 Months

• Recommended dose: 60-65 mg/kg/day, though pharmacokinetic data suggests higher doses may be appropriate 5
• Many practitioners are uncertain about safe dosing in this age group, highlighting the need for careful consideration 5

Administration Considerations

• Route: Oral suspension is preferred over suppositories for more consistent absorption and response 4
• Measuring devices: Use calibrated oral syringes (3-mL or 5-mL) for accurate measurement in infants and young children 7
• Dosing interval: Every 4-6 hours as needed, with 4-hour intervals providing more consistent fever control 1, 2

Clinical Efficacy

• Antipyretic effect: Requires >10 mg/kg to maintain temperature reduction of 1.5°C below baseline for 6 hours 4
• Analgesic effect: 10-15 mg/kg oral dose is effective for mild to moderate pain 3, 4
• Therapeutic plasma concentration: 4-18 mg/L (half-life 1-3.5 hours) 4
• Paracetamol demonstrates equivalent efficacy to aspirin at comparable doses for fever and pain control 4

Critical Safety Warnings

Common prescribing errors occur in 17% of cases, with doses exceeding 95 mg/kg/day being charted 5

• Cumulative toxicity leading to hepatic and renal damage occurs with chronic use exceeding 90 mg/kg/day 5
• Younger children (under 3 months) are at higher risk due to uncertain dosing guidelines and practitioner unfamiliarity 5
• Pharmacy and nursing staff audits help prevent administration of excessive doses despite incorrect prescribing 5

Alternative Therapy

• Ibuprofen may be considered as second-line treatment if paracetamol is ineffective for fever management 7
• For severe pain, paracetamol provides significant additive analgesic effect when combined with opiates 3