METHODS OF INTRAVENOUSLY ADMINISTERING SOTALOL
Methods of administering a 5-hour IV loading dose of sotalol and one or more oral maintenance dose(s) or one or more 5-hour IV maintenance dose(s) in amounts effective for treating a cardiovascular condition are described. Methods of administering a 1-hour IV loading dose of sotalol and one or more 5-hour IV maintenance dose(s) in amounts effective for treating a cardiovascular condition are also described. The subject can be discharged prior to administration of any maintenance doses, after administration of a single maintenance dose, or after administration of two or more maintenance doses.
1 . A method of administering sotalol, comprising:
administering one or more IV dosage of sotalol hydrochloride to a subject, over a period of more than 1 hour and up to 5 hours;
wherein one or more of the IV dosages comprises an IV loading dose and one or more IV or oral maintenance dose;
wherein the IV loading dose, the IV maintenance dose, and the oral maintenance dose comprises an amount of sotalol hydrochloride in the range of 20-260 mg sotalol.
2 . The method of claim 1 , wherein:
the subject is being initiated on an 80 mg oral maintenance dose and the subject is administered 50-100 mg as the IV loading dose.
3 . The method of claim 1 , wherein:
the subject is being initiated on a 120 mg oral maintenance dose and the subject is administered 75-130 mg as an IV loading dose.
4 . The method of claim 1 , wherein:
the subject is being escalated from an 80 mg oral maintenance dose to a 120 mg oral maintenance dose; and
the subject is administered 60-115 mg as an IV loading dose.
5 . The method of claim 1 , wherein:
the subject is being escalated from a 120 mg oral maintenance dose to a 160 mg oral maintenance dose; and
the subject is administered 70-150 mg as an IV loading dose.
6 . The method of claim 1 , wherein:
the subject is being escalated from a 160 mg oral maintenance dose to a 240 mg oral maintenance dose; and
the subject is administered 100-225 mg as an IV loading dose.
7 . The method of claim 1 , wherein the subject has a cardiovascular condition selected from atrial fibrillation, atrial flutter, atrial tachycardia, ventricular tachycardia, hemodynamically stable or unstable ventricular tachycardia, paroxysmal atrial fibrillation, ventricular fibrillation, ventricular arrhythmia, premature ventricular contractions (PVC s), paroxysmal supraventricular tachycardia, supraventricular tachycardia, junctional ectopic tachycardia, junctional tachycardia, heart failure, coronary artery disease, and pulmonary artery hypertension.
8 . The method of claim 1 , wherein the subject is naïve to sotalol or has not received sotalol for at least five (5) half-lives of sotalol.
9 . The method of claim 1 , wherein the IV loading dosage is a 5-hour infusion.
10 . The method of claim 1 , wherein:
the IV loading dose is administered to the subject while admitted to a facility capable of providing cardiac resuscitation and continuous electrographic monitoring.
11 . The method of claim 1 , further comprising:
administering one or more oral maintenance dose to the subject;
wherein the IV loading dose is administered to the subject while admitted to a facility capable of providing cardiac resuscitation and continuous electrographic monitoring;
wherein the subject is administered one or more of the oral maintenance doses before the subject is released from the facility.
12 . The method of claim 1 , further comprising:
administering one or more oral maintenance dose to the subject;
wherein the IV loading dose is administered to the subject while admitted to a facility capable of providing cardiac resuscitation and continuous electrographic monitoring;
wherein the subject is administered one or more of the oral maintenance doses after the subject is released from the facility.
13 . The method of claim 1 , further comprising:
administering one or more oral maintenance dose to the subject;
wherein the IV loading dose and a first oral maintenance dose are administered to the subject while admitted to a facility capable of providing cardiac resuscitation and continuous electrographic monitoring;
the subject is released from the facility capable of providing cardiac resuscitation and continuous electrographic monitoring; and
the subject is administered one or more additional oral dosage of sotalol hydrochloride after release from the facility capable of providing cardiac resuscitation and continuous electrographic monitoring.
14 . The method of claim 1 , wherein the subject is being treated for atrial fibrillation and/or atrial flutter.
15 . The method of claim 14 , wherein the subject is in sinus rhythm before being administered the IV loading dose.
16 . The method of claim 1 , wherein the subject is being treated for ventricular arrhythmia or ventricular tachycardia.
17 . The method of claim 1 , further comprising:
determining a QT or QTc interval of the subject before administering IV loading dosage and determining a second QT or QTc interval of the subject after administering the IV loading dosage, but before administering one or more oral dosage to the subject;
determining that the second QT or QTc interval is within a selected range;
administering one or more oral maintenance dose to the subject.
18 . The method of claim 1 , wherein the amount of sotalol hydrochloride in the IV loading dose is more than the amount of sotalol hydrochloride in one or more of the IV or oral maintenance doses.