Usage of antibiotics off-label, in neonates and children, is an important public health issue. An overwhelming number of antibiotics are marketed and prescribed without clear labeling for use in pediatrics. It presents an even larger and more complex issue in neonates, children younger than 2 years, and those with chronic and/or rare diseases due to a lack of good clinical trials in these pediatric subgroups. The purpose of off-label use is to benefit an individual patient. The article details the prevalence of off-label antibiotic use in pediatrics and the reasons for the same. An attempt is made to highlight the different recommendations for antibiotic use in two pediatric drug formularies, the non-availability of child-friendly formulations and the lack of studies on newer antibiotics in neonates and children that necessarily results in antibiotics being prescribed off-label in children.
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