Abstract Ref Number = APCP1238
Poster Presentation
Preeti Kachroo Bhagat,Karman Siddiqui,Oscar Della Pasqua GlaxoSmithKline Consumer Healthcare Consumer Healthcare R D, GlaxoSmithKline Consumer Healthcare, Singapore Clinical Pharmacology Modelling Simulation, GlaxoSmithKline, Uxbridge, UK
Background : Paracetamol is a first-line treatment for pain and fever. Pediatric dosing regimens are based on weight and/or age, depending on region. This review was conducted to evaluate the impact of weight/age on paracetamol pharmacokinetics, compare regional differences in weight- versus age-based dosing, and assess associated risk of misdosing. Material : This is a narrative review of clinical trials, systematic reviews, meta-analyses, surveys, and guidelines identified via PubMed (through 11/29/2017). Results : Maturation processes and developmental growth alter drug distribution and metabolism, which vary by weight and age in infants and young children. Weight-based paracetamol dosing is supported by efficacy and pharmacokinetic data, and preferred when weight is known. Recommended doses typically are 10?15 mg/kg q4?6h (max 4 times daily; 60 mg/kg/day). The World Health Organization recommends weight-banded regimens by age (0–29 days: 5–10 mg/kg q6–8h; 30 days–3 months: 10 mg/kg q4–6h; 3 months–12 years: 10–15 mg/kg q4–6h). The complexity of weight-based dosing is concerning because low literacy contributes to dosing errors, and resulting over- or underdosing carries potential for hepatotoxicity or diminished therapeutic effect, respectively. Age-based dosing, recommended in some countries (eg, UK, Ireland, Indonesia), is simpler but less precise because weight varies among same-aged children. Narrower age-group categories (with more doses) may not increase appropriate dosing because age does not independently influence paracetamol pharmacokinetics, especially in children >2 years. Furthermore, child growth rates vary regionally, yet weight-for-age reference data are lacking for many countries, hindering development of regional age-based dosing regimens. Conclusions : When possible, paracetamol should be dosed based on children’s weight, which has a greater influence than age on pharmacokinetics. Nonetheless, age-based dosing may be safe and efficacious, particularly for average-weight children, and may be considered if weight is unknown and the dosing regimen is optimized for the local population.
Keywords: acetaminophen pediatric misdosing paracetamol
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