Claims for Patent: 12,390,431

Summary for Patent: 12,390,431

Title:	Method of escalating sotalol hydrochloride dosing
Abstract:	This disclosure provides a method of safely and rapidly initiating or escalating oral sotalol therapy by administering an intravenous dosage of sotalol followed by oral sotalol twice daily.
Inventor(s):	John Charin Somberg, Brandon Ira Kashfian, Janos Molnar
Assignee:	Altathera Pharmaceuticals LLC
Application Number:	US16/693,312
Patent Claims:	1. A method of rapidly escalating a subject's oral sotalol hydrochloride therapy to a higher oral dose, the method comprising: (1) identifying a subject as having symptomatic atrial fibrillation or atrial flutter, who is currently in sinus rhythm, who is under QTc monitoring, and who is receiving 120 mg oral sotalol hydrochloride therapy such that the subject has a concentration of sotalol resulting therefrom; (2) escalating the concentration of sotalol of the subject to a higher concentration, by administering over a period of 1 hour, a single IV dosage of sotalol hydrochloride in an amount in the range of 99 mg to 105.6 mg and at a rate in the range of 1.65-1.76 mg/min; and (3) after completion of the single IV dosage of sotalol hydrochloride, increasing the amount of the subject's oral dosing from 120 mg to 160 mg by administering at least one oral dose of 160 mg sotalol hydrochloride to the subject. 2. The method of claim 1, further comprising repeating oral administration of the 160 mg oral dose of sotalol hydrochloride at least once at a selected interval. 3. The method of claim 2, wherein the administering of the oral dose of 160 mg starts at about 4-12 hours after completion of the single IV dosage of sotalol hydrochloride. 4. The method of claim 3, wherein the administering of the oral dose of 160 mg starts at about 4 hours after completion of the single IV dosage of sotalol hydrochloride. 5. The method of claim 1, wherein: the administering of the oral dose of 160 mg starts at about 6 hours after completion of the single IV dosage of sotalol hydrochloride. 6. The method of claim 5, further comprising repeating oral administration of the 160 mg oral dose of sotalol hydrochloride at a selected interval, wherein the repeating of the oral administration is performed at least once. 7. The method of claim 1, wherein: the administering of the oral dose of 160 mg starts at about 4-12 hours after completion of the single IV dosage of sotalol. 8. The method of claim 7, further comprising repeating oral administration of the 160 mg oral dose of sotalol hydrochloride at a selected interval, wherein the administering of the oral dose of 160 mg and the repeating of the oral administration is performed at least once and according to a once daily or twice daily schedule. 9. The method of claim 1, wherein the subject received a 120 mg oral dose of sotalol hydrochloride 12-24 hours before administration of the single IV dose. 10. The method of claim 2, wherein the administering of the oral dose of 160 mg and the repeating is performed according to a once or twice daily schedule. 11. The method of claim 3, wherein the administering of the oral dose of 160 mg and the repeating is performed according to a once or twice daily schedule.