SOTALOL HYDROCHLORIDE DOSING
The present invention provides novel methods of administering sotalol hydrochloride to patients in need thereof.
1 . A method of administering sotalol hydrochloride, comprising:
a. administering a single intravenous (IV) dose of 55-125 mg sotalol hydrochloride over a period of 1 hour to a subject having had symptomatic atrial fibrillation or atrial flutter, wherein the subject is currently in sinus rhythm; and
b. after completion of the IV dose, administering oral dosing of one or more oral dose of sotalol hydrochloride to the subject in an amount of 80 mg or 120 mg.
2 . The method of claim 1 , wherein the oral dosing is initiated 4-12 hours after completion of the IV dose.
3 . The method of claim 1 , wherein:
the IV dose is 55-85 mg sotalol hydrochloride; and
the oral dosing comprises administering one or more oral dose in the amount of 80 mg.
4 . The method of claim 1 , wherein:
the IV dose is 75-115 mg sotalol hydrochloride; and
the oral dosing comprises administering one or more oral dose in the amount of 120 mg.
5 . The method of claim 3 , wherein the oral dosing is initiated 4-12 hours after completion of the IV dose.
6 . The method of claim 5 , wherein one or more of the oral doses are administered at a 12-48 hour interval from initiation of the oral dosing.
7 . The method of claim 6 , wherein:
the oral dosing is initiated 4-6 hours after completion of the IV dose; and
one or more of the oral doses are administered at a 12-24 hour interval from initiation of the oral dosing.
8 . The method of claim 6 , wherein:
the oral dosing is initiated 6-12 hours after completion of the IV dose; and
one or more of the oral doses are administered at a 24-48 hour interval from initiation of the oral dosing.
9 . The method of claim 4 , wherein the oral dosing is initiated 4-12 hours after completion of the IV dose.
10 . The method of claim 9 , wherein one or more of the oral doses are administered at a 12-48 hour interval from initiation of the oral dosing.
11 . The method of claim 10 , wherein:
the oral dosing is initiated 4-6 hours after completion of the IV dose; and
one or more of the oral doses are administered at a 12-24 hour interval from initiation of the oral dosing.
12 . The method of claim 10 , wherein:
the oral dosing is initiated 6-12 hours after completion of the IV dose; and
one or more of the oral doses are administered at a 24-48 hour interval from initiation of the oral dosing.
13 . The method of claim 1 , wherein the subject is naïve to sotalol prior to administering the single IV dose of sotalol hydrochloride.
14 . The method of claim 1 , wherein:
the administering of the single IV dose of sotalol hydrochloride comprises escalating the subject to a higher oral dosage; and
one or more of the oral doses comprise 120 mg sotalol hydrochloride.
15 . The method of claim 3 , wherein:
the single IV dose comprises 60-85 mg sotalol hydrochloride; and
one or more of the oral doses comprise 80 mg sotalol hydrochloride.
16 . The method of claim 1 , wherein:
the single IV dose comprises 82-113 mg sotalol hydrochloride; and
one or more of the oral doses comprise 80 mg or 120 mg sotalol hydrochloride.
17 . The method of claim 16 , wherein the oral dosing is administered at a 12-hour interval.
18 . The method of claim 1 , wherein:
the subject has renal impairment;
the subject has a creatinine clearance in the range of 10-90 mL/min; and
the oral dosing is administered at a 12-hour interval.
19 . The method of claim 18 , wherein:
the single IV dose comprises 70-125 mg sotalol hydrochloride.
20 . The method of claim 19 , wherein the subject is naïve to sotalol.