Method of initiating and 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.

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.