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Somberg J, Vinks A, Dong M, Molnar J.  Model-Informed Development of Sotalol Loading and Dose Escalation Employing an Intravenous Infusion. Cardiology Research, North America, 11, Aug 2020. doi:10.14740/cr1143

Sotalol is often employed to prevent recurrence of symptomatic atrial flutter/atrial fibrillation.  Because sotalol can prolong the QT interval excessively causing ventricular arrhythmias, a 3-day in-hospital loading or dose escalation period is mandated with oral administration in the product label.  Using model-informed drug development techniques, simulations were developed for initiation and dose escalation of sotalol therapy by employing an intravenous loading dose followed by oral sotalol administrations.  In patients with normal renal function, using an intravenous loading dose followed by oral administrations permits safe initiation or dose escalation of sotalol in 1 day instead of the 3-day dosing regimen with oral administration.

Highlights of Prescribing Information

Boxed Warning, Indications, and Important Safety Information


Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation. To minimize the risk of drug induced arrhythmia, initiate or uptitrate intravenous sotalol in a facility that can provide continuous electrocardiographic monitoring and cardiac resuscitation [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)].
Do not initiate intravenous sotalol therapy if the baseline QTc is longer than 450 ms. If the QTc prolongs to 500 ms or greater, reduce the dose or discontinue. (2.3)