IP Library Granted Patent US 12685716
Granted Patent B1
US 12685716 · App. 18/940,629 · Granted Jul 21, 2026

Methods for initiating sotalol

Inventors: Robert D. O. Kennedy (Traverse City, MI); Dina M. Kennedy (Traverse City, MI)
A61K31/18A61B5/318A61K9/0019A61K9/0053A61N1/3962A61P9/06
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Quick Facts
Patent No.
US 12685716
App. No.
18/940,629
Granted
Jul 21, 2026
Kind
B1
Abstract

This disclosure describes a safe, effective, and novel method of preventing or treating atrial fibrillation, atrial flutter, atrial tachycardia, premature ventricular contractions, ventricular tachycardia, or a combination thereof using an initial intravenous sotalol dose followed by same day discharge and, in some cases, discharge following the administration of an intravenous dose of sotalol. This shortened time frame allows subjects to be discharged from the hospital less than 18 hours after sotalol initiation.

Claims (56)

1 . A method of sotalol administration for treatment of one or more cardiac arrhythmias, comprising:

determining a creatinine clearance of a subject prior to admission at a medical facility;

receiving the subject for admission at a medical facility based at least in part on the creatinine clearance of the subject;

determining a baseline QT or QTc interval and vital signs of the subject;

administering to the subject an initial intravenous (IV) loading dose of sotalol hydrochloride over a period of up to 1 hour, wherein the IV loading dose is selected from an amount ranging from 60 mg to 125 mg responsive to determining the creatinine clearance of the subject;

determining a second QT or QTc interval of the subject;

determining that the second QT or QTc interval is within a selected range, wherein the selected range is less than about 500 msec or less than about 550 msec for ventricular conduction delay;

administering oral sotalol hydrochloride to the subject responsive to determining the second QT or QTc interval is within the selected range including:

administering a first oral dose of 40 mg to 160 mg after completion of the initial IV loading dose; and

administering one or more subsequent oral dose(s) of 40 mg to 160 mg at about 12 hour, 24 hour, or 48 hour interval(s) after the first oral dose; and

discharging the subject from the medical facility less than 10 hours after administering the initial IV dose, on a same calendar day.

2 . The method of claim 1 , further comprising:

administering the first oral dose of sotalol to the subject after administering the initial IV dose;

performing a first subsequent electrocardiogram (ECG) on the subject after administering the first oral dose of sotalol to the subject after administering the initial IV dose, wherein the subject consumes the first oral dose of sotalol prior to the first subsequent ECG;

providing instructions to the subject for taking a second oral dose of sotalol, wherein the subject consumes the second oral dose after discharge from the medical facility;

receiving the subject for a second subsequent ECG at the same medical facility or at a different medical facility; and

performing the second subsequent ECG on the subject, wherein the subject consumes the second oral dose of sotalol prior to the second subsequent ECG, and the second subsequent ECG is performed as an outpatient test.

3 . The method of claim 2 , further comprising:

receiving the subject for IV sotalol administration and discharging the subject on the same day; and

receiving the subject for the second subsequent ECG and performing the second subsequent ECG on a subsequent day.

4 . The method of claim 1 , further comprising:

providing instructions to the subject for taking a first oral dose of sotalol, wherein the subject consumes the first oral dose after discharge from the medical facility; and

receiving the subject at the same medical facility or at a different medical facility for an ECG following consumption of the first oral dose, wherein the ECG is performed as an outpatient test.

5 . The method of claim 1 , further comprising:

providing instructions to the subject for taking a first oral dose, wherein:

the subject presents with normal sinus rhythm; and

the subject consumes the first oral dose after discharge from the medical facility.

6 . The method of claim 1 , wherein:

the subject presents with persistent cardiac arrhythmia; and

direct current cardioversion (DCCV) is performed on the subject.

7 . The method of claim 1 , wherein:

the subject presents with a persistent cardiac arrhythmia; and

the method comprises administering the initial IV dose of sotalol to the subject while the subject has the persistent cardiac arrhythmia.

8 . The method of claim 7 , wherein administering the initial IV dose of sotalol to the subject is effective to convert the persistent cardiac arrhythmia to a normal sinus rhythm.

9 . The method of claim 7 , wherein direct current cardioversion (DCCV) is not performed on the subject.

10 . The method of claim 7 , wherein:

the method comprises administering direct current cardioversion (DCCV) to the subject;

the DCCV converts the persistent cardiac arrhythmia to a normal sinus rhythm; and

the DCCV is administered after the initial IV dose and prior to discharging the subject from the medical facility.

11 . The method of claim 7 , further comprising:

administering a first oral dose of sotalol to the subject after administering the initial IV dose; and

administering direct current cardioversion (DCCV) after administering the first oral dose of sotalol to the subject.

12 . The method of claim 1 , further comprising:

administering a first oral dose of sotalol to the subject after administering the initial IV dose; and

administering direct current cardioversion (DCCV) to the subject after administering the first oral dose of sotalol to the subject, wherein:

the subject presents with a persistent cardiac arrhythmia prior to administering the initial IV dose, and

the DCCV converts the persistent cardiac arrhythmia to a normal sinus rhythm.

13 . The method of claim 1 , wherein:

the subject presents with a persistent cardiac arrhythmia; and

the method comprises administering direct current cardioversion (DCCV) to the subject;

the DCCV converts the persistent cardiac arrhythmia to a normal sinus rhythm; and

the DCCV is administered prior to the initial IV dose.

14 . The method of claim 1 , wherein the subject is in sinus rhythm, not currently in sinus rhythm, or has been or will be converted to sinus rhythm with sotalol and/or cardioversion, and wherein sotalol hydrochloride is administered for the treatment.

15 . The method of claim 1 , wherein the method of sotalol administration for the treatment of the one or more cardiac arrhythmias comprises a subject presenting with one or more following cardiovascular conditions:

atrial tachycardia, atrial flutter, atrial fibrillation, premature ventricular contractions, and ventricular tachycardia.

16 . The method of claim 1 , wherein discharging the subject from the medical facility less than 10 hours after administering the initial IV dose avoids an overnight hospital stay.