US2019380605A1PendingUtilityA1

Method of Administering Sotalol IV/SWITCH

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Assignee: UNIV MARYLANDPriority: Apr 5, 2018Filed: Aug 23, 2019Published: Dec 19, 2019
Est. expiryApr 5, 2038(~11.6 yrs left)· nominal 20-yr term from priority
Inventors:Vijay IvaturiJogarao Gobburu
A61B 5/36A61B 5/4839G16H 50/20G16H 50/30G16H 20/17A61K 9/0053A61K 31/18A61K 9/0019A61B 5/046A61B 5/361A61B 5/349
53
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Claims

Abstract

Embodiments of the invention are broadly drawn to methods for determining an optimum dose of an antiarrhythmic drug, for example sotalol. In particular, the method involves titrating the dose of the drug gradually to determine the optimum plasma concentration for a patient, whether the patient has normal or abnormal renal function.

Claims

exact text as granted — not AI-modified
1 - 33 . (canceled) 
     
     
         34 . A method of preventing atrial fibrillation or atrial flutter in a subject in need thereof, the method comprising intravenously administering to a subject 20 mg to 80 mg of sotalol hydrochloride over a period of 1 hour to 3 hours. 
     
     
         35 . The method of  claim 34 , wherein 60 mg to 70 mg of sotalol hydrochloride is intravenously administered over a period of 1 hour. 
     
     
         36 . The method of  claim 34 , further comprising measuring the QTc change from baseline QTc at the end of the intravenous administration. 
     
     
         37 . The method of  claim 34 , wherein the intravenous administration of sotalol hydrochloride results in a sotalol steady state C max  of about 800 ng/mL in the subject about 4 hours after initiation of the administration. 
     
     
         38 . The method of  claim 34 , further comprising administering a first oral dose to the subject of 80 mg of sotalol hydrochloride. 
     
     
         39 . The method of  claim 38 , wherein the first oral dose is initiated at the end of the intravenous sotalol administration. 
     
     
         40 . The method of  claim 38 , further comprising administering a second oral dose of 80 mg of sotalol hydrochloride to the subject. 
     
     
         41 . The method of  claim 40 , wherein the second oral dose is initiated 12 hours after the end of the intravenous sotalol administration. 
     
     
         42 . A method of reducing a hospital stay of a subject in need of prevention of atrial fibrillation or atrial flutter, the method comprising:
 (a) intravenously administering 20 mg to 80 mg of sotalol hydrochloride to a subject in need thereof over a period of 1 hour to 3 hours;   (b) administering a first oral dose to the subject; and   (c) administering a second oral dose to the subject.   
     
     
         43 . The method of  claim 42 , wherein the hospital stay is reduced to about 1 day. 
     
     
         44 . The method of  claim 42 , wherein 60 mg to 70 mg of sotalol hydrochloride is administered intravenously over a period of 1 hour. 
     
     
         45 . The method of  claim 42 , further comprising measuring the QTc change from baseline QTc at the end of the intravenous administration. 
     
     
         46 . The method of  claim 42 , wherein the intravenous administration of sotalol hydrochloride results in a sotalol steady state C max  of about 800 ng/mL in the subject about 4 hours after initiation of the administration. 
     
     
         47 . The method of  claim 42 , wherein the first oral dose comprises 80 mg of sotalol hydrochloride. 
     
     
         48 . The method of  claim 47 , wherein the first oral dose is initiated at the end of the intravenous administration. 
     
     
         49 . The method of  claim 42 , wherein the second oral dose comprises 80 mg of sotalol hydrochloride. 
     
     
         50 . The method of  claim 49 , wherein the second oral dose is initiated 12 hours after the end of the intravenous administration. 
     
     
         1 - 33 . (canceled) 
     
     
         34 . A method of preventing atrial fibrillation or atrial flutter in a subject in need thereof, the method comprising intravenously administering to a subject 20 mg to 80 mg of sotalol hydrochloride over a period of 1 hour to 3 hours. 
     
     
         35 . The method of  claim 34 , wherein 60 mg to 70 mg of sotalol hydrochloride is intravenously administered over a period of 1 hour. 
     
     
         36 . The method of  claim 34 , further comprising measuring the QTc change from baseline QTc at the end of the intravenous administration. 
     
     
         37 . The method of  claim 34 , wherein the intravenous administration of sotalol hydrochloride results in a sotalol steady state C max  of about 800 ng/mL in the subject about 4 hours after initiation of the administration. 
     
     
         38 . The method of  claim 34 , further comprising administering a first oral dose to the subject of 80 mg of sotalol hydrochloride. 
     
     
         39 . The method of  claim 38 , wherein the first oral dose is initiated at the end of the intravenous sotalol administration. 
     
     
         40 . The method of  claim 38 , further comprising administering a second oral dose of 80 mg of sotalol hydrochloride to the subject. 
     
     
         41 . The method of  claim 40 , wherein the second oral dose is initiated 12 hours after the end of the intravenous sotalol administration. 
     
     
         42 . A method of reducing a hospital stay of a subject in need of prevention of atrial fibrillation or atrial flutter, the method comprising:
 (a) intravenously administering 20 mg to 80 mg of sotalol hydrochloride to a subject in need thereof over a period of 1 hour to 3 hours;   (b) administering a first oral dose to the subject; and   (c) administering a second oral dose to the subject.   
     
     
         43 . The method of  claim 42 , wherein the hospital stay is reduced to about 1 day. 
     
     
         44 . The method of  claim 42 , wherein 60 mg to 70 mg of sotalol hydrochloride is administered intravenously over a period of 1 hour. 
     
     
         45 . The method of  claim 42 , further comprising measuring the QTc change from baseline QTc at the end of the intravenous administration. 
     
     
         46 . The method of  claim 42 , wherein the intravenous administration of sotalol hydrochloride results in a sotalol steady state C max  of about 800 ng/mL in the subject about 4 hours after initiation of the administration. 
     
     
         47 . The method of  claim 42 , wherein the first oral dose comprises 80 mg of sotalol hydrochloride. 
     
     
         48 . The method of  claim 47 , wherein the first oral dose is initiated at the end of the intravenous administration. 
     
     
         49 . The method of  claim 42 , wherein the second oral dose comprises 80 mg of sotalol hydrochloride. 
     
     
         50 . The method of  claim 49 , wherein the second oral dose is initiated 12 hours after the end of the intravenous administration.

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