Frequently Asked Questions
Get answers to common inquiries regarding Sotalol IV and its usage in pediatric patients.
Table of Contents
What are the indications for usage of Sotalol IV in pediatrics?
Sotalol IV is indicated for:
- the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia in adult and pediatric patients.
Limitations of Use:
Sotalol has not been shown to enhance survival in patients with life-threatening ventricular arrhythmias. - the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)) in adults and pediatric patients with highly symptomatic AFIB/AFL who are currently in sinus rhythm.
Limitations of Use:
Because sotalol can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom AFIB/AFL is highly symptomatic.
What are the benefits of Sotalol IV over oral sotalol for pediatric patients?
Sotalol IV offers the same active molecule as oral sotalol but in an intravenously infused formulation. Sotalol IV bypasses the GI tract, supporting more predictable exposure and use in patients with limited oral or GI tolerance. In addition, the rapid onset of Sotalol IV allows for faster assessment of therapeutic response than oral dosing alone.
The combined analysis of two unblinded, multicenter trials of oral sotalol with 59 children, aged between 3 days and 12 years, showed the pharmacokinetics of sotalol to be first order, or that a constant proportion is eliminated over time, with a mean elimination half-life of 9.5 hours.1 These characteristics make dose adjustments, discontinuation, and transition from intravenous to oral sotalol therapy straightforward.
Are there studies and safety data available for Sotalol IV in pediatric patients?
Yes. The FDA-approved label includes a pediatric indication for the initiation of treatment for arrhythmias, and Sotalol IV is used at pediatric institutions across the country for treatment of conditions like atrial flutter.
Intravenous sotalol is the same molecule as other forms of sotalol. It has been used and studied in adults and children for decades.
How do I learn more about sotalol, and how do I safely administer it?
AltaThera Pharmaceuticals maintains a growing library of healthcare provider resources regarding the use of Sotalol IV in pediatric patients.
Visit our Pediatric Dosing & Administration page to see information on recommended dosing and safety considerations for Sotalol IV.
You can also review the full prescribing information for Sotalol IV by clicking here.
Is allergen information available for Sotalol IV and the vial in which it is packaged?
1 mL of Sotalol IV is composed of 15 mg sotalol hydrochloride, q.s. water for injection, and 2.9 mg glacial acetic acid.
The vial is made of glass, and the stopper is made of Datwyler FM257/2, which is latex-free. You can find more information on the composition of the stopper here.
How do I order Sotalol IV? Is there information on proper storage and shelf life?
You can find information on ordering and proper storage of Sotalol IV on our Ordering Info page.
What's the history of sotalol? When was the intravenous form introduced?
Sotalol is both a Class II and Class III antiarrhythmic. It was first synthesized and studied in the 1960s, and in 1992 the oral form was approved in the US for treatment of life threatening ventricular arrhythmias.2
The intravenous form of sotalol, today known as Sotalol IV, was initially approved by the FDA in 2009,3 but only as a substitute for oral therapy in patients unable to take oral medication, and remained largely unavailable until it was relaunched in 2015 by AltaThera Pharmaceuticals.
In 2020, Sotalol IV was approved for IV loading for oral maintenance.4 This approval was accomplished using the FDA Model-Informed Drug Development program, or MIDD. Because of previous pharmacokinetics data and the multitude of safety and efficacy studies already existing on oral sotalol, which is the same molecule, MIDD made the development and approval process much more efficient.
In 2025, Sotalol IV received an expanded label from FDA including a pediatric indication, further supporting Sotalol IV’s use in the treatment of dangerous arrhythmias that can be costly to treat; including atrial fibrillation, atrial flutter, and documented life-threatening ventricular arrhythmias such as sustained ventricular tachycardia.1 FDA also approved an update to the label to reflect a change to the renal function calculation for recommended adult loading, which now uses the patient’s estimated glomerular filtration rather than creatinine clearance.1 This adjustment brings the label more in line with current nephrology practice and enhances dosing to ensure safe and efficacious use of the drug.
I have more questions regarding Sotalol IV or AltaThera Pharmaceuticals.
Please contact us with additional questions and our team will be in touch. We look forward to working with you!
REFERENCES
- Sotalol IV [package insert]. Chicago, IL: AltaThera Pharmaceuticals; 07/2025.
- BetaPace AF (sotalol hydrochloride) [package insert]. Zug, CH: Covis Pharma; 06/2023.
- Sotalol hydrochloride injection for intravenous use [package insert]. Lake Bluff, IL: Academic Pharmaceuticals; 07/2009.
- Sotalol IV [package insert]. Chicago, IL: AltaThera Pharmaceuticals; 03/2020.