The efficacy and safety of ibuprofen in children and adults is well-established [1, 2]. Ibuprofen is approved as an overthe-counter medication in many countries and is the most commonly used NSAID for the treatment of mild-moderate pain, fever and inflammation in children [1, 2]. Table 1 presents an overview of the use of ibuprofen in infants aged 3–۶ months. Of note, the use of ibuprofen in infants aged 3–۶ months is approved in some countries (e.g. the UK and Australia), but not elsewhere (e.g. the USA and several EU countries). A weight-based approach should be employed first to determine whether the use of ibuprofen is appropriate, and then to calculate the appropriate dosage for the individual (Table 1). Maximum daily doses should not be exceeded and the history of the patient and contraindications to the use of ibuprofen should be carefully considered (Table 1) This article provides a brief overview of the available evidence on the efficacy and safety of the short-term use of ibuprofen in infants aged 3–۶ months for the relief of pain and fever, as reviewed by Ziesenitz et al. [2]. The use of ibuprofen in the treatment of patent ductus arteriosus in infants is well established [3] and is not discussed further.

No correlation between age and ibuprofen pharmacokinetics …

No associations between age and ibuprofen pharmacokinetics were found in clinical studies of oral, rectal or intravenous ibuprofen across a range of indications (Table 2) [2]. For example, in a study investigating the effect of age on the pharmacokinetic properties and antipyretic effects of oral ibuprofen 8 mg/kg in 49 infants and children aged 3 months to 10.4 years (median 2.5 years), there was no meaningful relationship between age and ibuprofen pharmacokinetics [4]; however, clearance appeared to be enhanced in children aged up to 5 years. Notably, some efficacy parameters (e.g. a rapid onset of antipyresis and a greater maximum antipyretic effect) were more favourable in younger children than in those who were older; the relatively greater body surface area of younger patients may contribute to more efficient dissipation of heat [4]. The mean change in temperature was – 0.24 C per mg/L of ibuprofen in the plasma (effect compartment concentration) [4].