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Frequently Asked Questions

Get answers to common inquiries regarding Sotalol IV.

If you can’t find what you’re looking for, be sure to contact us by clicking here so that we can get your questions answered.

Table of Contents

What are the indications for usage of Sotalol IV?

Sotalol IV is indicated for:
  • Maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter in patients with symptomatic AFIB/AFL] who are currently in sinus rhythm
  • The treatment of life-threatening ventricular tachycardia

What are the benefits of Sotalol IV over oral sotalol?

Sotalol IV is the same molecule as oral sotalol, but differs in formulation and thus presents multiple advantages over oral sotalol. Because 1 hour1 of Sotalol IV infusion achieves the same maximum serum concentration as 3 days2 of oral sotalol administration, clinicians can more quickly determine patient response to sotalol at chosen therapeutic levels. This may allow hospital discharge in 20-24 hours1, compared to the 72-hour2 discharge typical with oral loading. Sotalol IV can be initiated at either 80* or 120 mg oral dosing1, while oral sotalol’s labeling requires a starting dose of 80mg2. These changes combine to create opportunities to reduce patient length of stay, improve bed availability, and generally manage patients more effectively within an institution.

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 Sotalol IV including a free online training and certificate programYou can use these materials to learn more about Sotalol IV, see recommended monitoring information, and more. 

Visit our Dosage & Administration page to see recommended dosing for Sotalol IV. 

You can also review the full prescribing information for Sotalol IV (sotalol hydrochloride injection [15 mg/mL]) by clicking here.

Have there been any recent studies published on Sotalol IV?

A selection of recent studies published on Sotalol IV can be found on our Research page.

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 anti-arrhythmic. 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. In 2000 it was approved for rhythm control of atrial fibrillation. 

The intravenous form, today known as Sotalol IV, was initially approved by the FDA in 2009, 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. 

This new 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. 

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
1 Sotalol IV [package insert]. Chicago, IL: AltaThera Pharmaceuticals; 09/2023.
2 BetaPace AF (sotalol hydrochloride) [Full Prescribing Information]. Zug, CH: Covis Pharma; 06/2023.

Highlights of Prescribing Information

Boxed Warning, Indications, and Important Safety Information

WARNING: LIFE THREATENING PROARRHYTHMIA

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)