All medicines should be administered with two aims in mind: to effectively treat a specific disease and to avoid disproportional side effects. But the effects of a medicine given to a newborn baby can vary drastically compared with adults and even other pediatric populations. There is a recognized need worldwide for more research relating to medicinal products and neonates, but despite this, it is still common practice to prescribe medicines to newborns off label. The prescription is often made by extrapolating from the dosing regimens and indications validated in other pediatric populations – and rarely on neonatal pathophysiology.
& Sherwin, C. M.
(2016). Therapeutic Orphans. The Medicine Maker.