METHOD OF INITIATING AND ESCALATING SOTALOL HYDROCHLORIDE DOSING
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.
1 - 7 . (canceled)
8 . A sotalol hydrochloride dosing method, the method comprising:
(1) administering a single IV dosage of sotalol hydrochloride, for a period of 1 hour, to a subject who is under QTc monitoring, wherein the single IV dosage is administered to the subject in an amount of about 55-128 mg;
(2) monitoring QTc during the administering of the IV; and
(3) for the subject who's QTc during the administering of the IV is less than a 20% increase from baseline, administering an oral dose after completion of the single IV dosage.
9 . The method of claim 8 , further comprising repeating oral administration of sotalol hydrochloride at least once at a selected interval.
10 . The method of claim 9 , wherein the administering of the oral dose and the repeating are performed according to a once daily or twice daily schedule.
11 . The method of claim 9 , wherein the interval is selected from 12 hours, 24 hours, or 48 hours.
12 . The method of claim 9 , wherein the administering of the oral dose is performed 2-12 hours after completion of the single IV dosage of sotalol hydrochloride.
13 . The method of claim 12 , wherein the administering of the oral dose is performed 2-4 hours after completion of the single IV dosage of sotalol hydrochloride.
14 . The method of claim 13 , wherein the repeating of the oral administration is performed at least once at a 12- to 48-hour interval.
15 . The method of claim 12 , wherein the administering of the oral dose is performed 4-12 hours after completion of the single IV dosage of sotalol hydrochloride.
16 . The method of claim 15 , wherein the repeating of the oral administration is performed at least once at a 12- to 48-hour interval.
17 . The method of claim 9 , further comprising assessing a QTc of the subject after each of the IV dosage, a first oral dosage, and a second oral dosage.
18 . The method of claim 17 , wherein the assessing of the QTc after each of the IV dosage, the first oral dosage, and the second oral dosage is completed in less than 24 hours.
19 . The method of claim 18 , wherein each QTc is less than a 20% increase from a baseline QTc of the subject.
20 . The method of claim 8 , wherein the sotalol hydrochloride is administered to treat or prevent atrial fibrillation or atrial flutter in the subject.
21 . The method of claim 8 , wherein the single IV dosage is administered to the subject in an amount of about 88-105.6 mg.
22 . The method of claim 21 , wherein the subject had received oral sotalol hydrochloride prior to the administering of the IV dosage.
23 . The method of claim 8 , wherein the subject had received oral sotalol hydrochloride prior to the administering of the IV dosage.
24 . The method of claim 8 , wherein the subject had not previously received sotalol hydrochloride.