Ivabradine Overdose in a Newborn: Precautions of Dispensing in Infants

Abstract

Ivabradine is currently approved to reduce heart rate in children with chronic heart failure and dilated cardiomyopathy. Ivabradine has also been used off-label in children to treat automatic tachyarrhythmias such as ectopic atrial tachycardia and junctional ectopic tachycardia. Adverse effects of ivabradine at physiological doses as well as its toxicity at supra-physiological doses have rarely been reported in adults. In children, weight-based dosing requires dilution of commercially available ivabradine oral solution for accuracy. We describe a case of ivabradine overdose in a newborn (treated for ectopic atrial tachycardia) secondary to inaccurate dosing leading to the infant receiving 10 times more drug than prescribed. This case highlights potential pitfalls of ivabradine prescription and preparation in children.

Ivabradine in a 15‐day‐old male neonate with refractory focal atrial tachycardia

“…In our case, return to normal sinus rhythm was observed 1 h after the first dose of ivabradine. It has been previously reported that it takes 1 h for ivabradine to reach its peak plasma concentration after oral/internal use 9 . Ivabradine‐related side effects were not observed in our case.…”

“…It has been previously reported that it takes 1 h for ivabradine to reach its peak plasma concentration after oral/internal use. 9 Ivabradine-related side effects were not observed in our case. Similar to the literature, ivabradine 0.05 mg/kg/dose was effective and safe in our patient.…”

Analysis of post-market adverse events of ivabradine: a real-world study base on FAERS database

“…Ivabradine primarily acts on the If channels of cardiac cells, modulating cardiac electrophysiological activity. The incidence of common adverse reactions is mainly concentrated in the cardiovascular system, especially affecting cardiac electrophysiology and the conduction system, including bradycardia, increased heart rate, and atrial brillation (AF) [6, [19][20][21]. Although the expected side effect of ivabradine is sinus bradycardia, the side effect of causing tachycardia seems contradictory to its mechanism of action.…”