Sotalol AF

Sotalol AF is a beta-blocker that affects the heart and circulation (blood flow through arteries and veins).

Sotalol AF is used to help keep the heart beating normally in people with certain heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart). Sotalol AF is used in people with atrial fibrillation or atrial flutter.

Another form of this medicine, called sotalol (Betapace, Sorine, Sotylize), is used to treat heart rhythm disorders of the ventricles (the lower chambers of the heart that allow blood to flow out of the heart). Sotalol is used in people with ventricular tachycardia or ventricular fibrillation.

Betapace AF is not used for the same conditions that Betapace, Sorine, and Sotylize are used for.

Sotalol AF may also be used for purposes not listed in this medication guide.

You will receive your first few doses of sotalol AF in a hospital setting where your heart can be monitored in case the medicine causes serious side effects.

You should not use this medicine if you have asthma, certain serious heart conditions, a history of Long QT syndrome, severe kidney disease, or low levels of potassium in your blood.

Avoid taking an antacid within 2 hours before or after you take sotalol AF. Some antacids can make it harder for your body to absorb sotalol AF.

Usual Adult Dose for Atrial Fibrillation:

Note: The generic form of this drug is used for atrial fibrillation or ventricular arrhythmia. The trade name Betapace (R) is for ventricular arrhythmia only and the trade name Betapace AF (R) is for atrial fibrillation only. These two trade names are not interchangeable.

SOTALOL: (ATRIAL FIBRILLATION, VENTRICULAR ARRHYTHMIA):
-Initial dose: 80 mg orally 2 times a day
-Doses should be adjusted gradually every 3 days in order to attain steady state plasma concentrations and allow for monitoring of QT intervals.
-Maintenance dose: The initial dose may be increased, if needed, to 240 or 320 mg orally per day (120 to 160 mg orally 2 times a day).
-Some patients with life-threatening refractory ventricular arrhythmias may require 480 to 640 mg per day in divided doses.
Comment:
-Because of the long terminal elimination half-life of this drug, dosing on more than a twice a day regimen is usually not necessary.

ORAL [BETAPACE AF (R)}: (ATRIAL FIBRILLATION):
-(STEP 1) Electrocardiographic assessment: Prior to administration of the first dose, the CrCl and the QT interval should be determined. If the baseline QT is greater than 450 msec, Betapace AF (R) is contraindicated:
-(STEP 2): Calculate the CrCl for the patient.
-(STEP 3):
Initial dose:
-If the CrCl is less than 40 mL/day: Betapace AF (R) is contraindicated
-If the CrCl is 40 to 60 mL/min: 80 mg once a day
-If the CrCl is greater than 60 mL/min: 80 mg orally 2 times a day
-(STEP 4): Continuous ECG monitoring with QT interval measurements should begin after the first dose and every 2 to 4 hours after each additional dose.
-(STEP 5); If the 80 mg dose level is tolerated and the QT interval remains less than 500 msec after at least 3 days (after 5 or 6 doses if patient receiving once-daily dosing), the patient can be discharged. Alternatively, during hospitalization, the dose can be increased to 120 mg twice daily and the patient followed for 3 days on this dose (followed for 5 or 6 doses if patient receiving once-daily dosing).
-If the 80 mg dose level (given twice a day or once-daily depending upon CrCl) does not reduce the frequency of relapses of atrial fibrillation/atrial flutter and is tolerated without excessive QT interval prolongation (i.e., greater than or equal to 520 msec), the dose level may be increased to 120 mg (twice a day or once-daily depending upon CrCl).
-If the 120 mg dose does not reduce the frequency of early relapse of atrial fibrillation/atrial flutter and is tolerated without excessive QT interval prolongation (greater than or equal to 520 msec), an increase to 160 mg (2 times a day or daily) depending upon CrCl), can be considered.
-Any increases in dosage should be done in a step-wise fashion as outlined above.
-Maintenance dose: 120 to 160 mg orally 2 times a day. Renal function and QT should be reevaluated regularly if medically warranted. If QT is 520 msec or greater (JT 430 msec or greater if QRS is greater than 100 msec), the dose should be reduced and patients should be carefully monitored until QT returns to less than 520 msec. If the QT interval is greater than or equal to 520 msec while on the lowest maintenance dose level (80 mg) the drug should be discontinued.

PARENTERAL:
-Initial: 112.5 mg IV once or twice daily
-Maintenance: 112.5 to 150 mg IV once or twice daily
-If 112.5 mg IV once or twice daily, at steady state, does not reduce the frequency of early relapse of arrhythmia and is tolerated without excessive QTc prolongation (greater than 520 msec), increase the dose to 150 mg IV once or twice daily.
-Start IV therapy only if the baseline QT interval is less than 450 msec. During initiation and titration, monitor the QT interval after the completion of each infusion. If the QT interval prolongs to 500 msec or greater, reduce the dose, decrease the infusion rate, or discontinue the drug.

Use: For the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm.

Usual Adult Dose for Atrial Flutter:

Note: The generic form of this drug is used for atrial fibrillation or ventricular arrhythmia. The trade name Betapace (R) is for ventricular arrhythmia only and the trade name Betapace AF (R) is for atrial fibrillation only. These two trade names are not interchangeable.

SOTALOL: (ATRIAL FIBRILLATION, VENTRICULAR ARRHYTHMIA):
-Initial dose: 80 mg orally 2 times a day
-Doses should be adjusted gradually every 3 days in order to attain steady state plasma concentrations and allow for monitoring of QT intervals.
-Maintenance dose: The initial dose may be increased, if needed, to 240 or 320 mg orally per day (120 to 160 mg orally 2 times a day).
-Some patients with life-threatening refractory ventricular arrhythmias may require 480 to 640 mg per day in divided doses.
Comment:
-Because of the long terminal elimination half-life of this drug, dosing on more than a twice a day regimen is usually not necessary.

ORAL [BETAPACE AF (R)}: (ATRIAL FIBRILLATION):
-(STEP 1) Electrocardiographic assessment: Prior to administration of the first dose, the CrCl and the QT interval should be determined. If the baseline QT is greater than 450 msec, Betapace AF (R) is contraindicated:
-(STEP 2): Calculate the CrCl for the patient.
-(STEP 3):
Initial dose:
-If the CrCl is less than 40 mL/day: Betapace AF (R) is contraindicated
-If the CrCl is 40 to 60 mL/min: 80 mg once a day
-If the CrCl is greater than 60 mL/min: 80 mg orally 2 times a day
-(STEP 4): Continuous ECG monitoring with QT interval measurements should begin after the first dose and every 2 to 4 hours after each additional dose.
-(STEP 5); If the 80 mg dose level is tolerated and the QT interval remains less than 500 msec after at least 3 days (after 5 or 6 doses if patient receiving once-daily dosing), the patient can be discharged. Alternatively, during hospitalization, the dose can be increased to 120 mg twice daily and the patient followed for 3 days on this dose (followed for 5 or 6 doses if patient receiving once-daily dosing).
-If the 80 mg dose level (given twice a day or once-daily depending upon CrCl) does not reduce the frequency of relapses of atrial fibrillation/atrial flutter and is tolerated without excessive QT interval prolongation (i.e., greater than or equal to 520 msec), the dose level may be increased to 120 mg (twice a day or once-daily depending upon CrCl).
-If the 120 mg dose does not reduce the frequency of early relapse of atrial fibrillation/atrial flutter and is tolerated without excessive QT interval prolongation (greater than or equal to 520 msec), an increase to 160 mg (2 times a day or daily) depending upon CrCl), can be considered.
-Any increases in dosage should be done in a step-wise fashion as outlined above.
-Maintenance dose: 120 to 160 mg orally 2 times a day. Renal function and QT should be reevaluated regularly if medically warranted. If QT is 520 msec or greater (JT 430 msec or greater if QRS is greater than 100 msec), the dose should be reduced and patients should be carefully monitored until QT returns to less than 520 msec. If the QT interval is greater than or equal to 520 msec while on the lowest maintenance dose level (80 mg) the drug should be discontinued.

PARENTERAL:
-Initial: 112.5 mg IV once or twice daily
-Maintenance: 112.5 to 150 mg IV once or twice daily
-If 112.5 mg IV once or twice daily, at steady state, does not reduce the frequency of early relapse of arrhythmia and is tolerated without excessive QTc prolongation (greater than 520 msec), increase the dose to 150 mg IV once or twice daily.
-Start IV therapy only if the baseline QT interval is less than 450 msec. During initiation and titration, monitor the QT interval after the completion of each infusion. If the QT interval prolongs to 500 msec or greater, reduce the dose, decrease the infusion rate, or discontinue the drug.

Use: For the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm.

Usual Adult Dose for Ventricular Arrhythmia:

Usual Adult Dose: Ventricular Arrhythmia:
(CA, US):
Note: The generic form of this drug is used for atrial fibrillation or ventricular arrhythmia. The trade name Betapace (R) is for ventricular arrhythmia only and the trade name Betapace AF (R) is for atrial fibrillation only. These two trade names are not interchangeable.

SOTALOL: (ATRIAL FIBRILLATION, VENTRICULAR ARRHYTHMIA):
-Initial dose: 80 mg orally 2 times a day
-Doses should be adjusted gradually every 3 days in order to attain steady state plasma concentrations and allow for monitoring of QT intervals.
-Maintenance dose: The initial dose may be increased, if needed, to 240 or 320 mg orally per day (120 to 160 mg orally 2 times a day).
-Some patients with life-threatening refractory ventricular arrhythmias may require 480 to 640 mg per day in divided doses.

Comment:
-Because of the long terminal elimination half-life of this drug, dosing on more than a twice a day regimen is usually not necessary.

ORAL (BETAPACE): (VENTRICULAR ARRHYTHMIA):
-Initial: 80 mg twice daily
-The initial dose may be increased 120 to 160 mg twice daily. The dosage should be adjusted gradually allowing 3 days between dosing increments in order to attain steady-state plasma concentrations and to allow monitoring of QT intervals. Graded dose adjustment will help prevent doses that are higher than necessary to control the arrhythmia. Most patients obtain a therapeutic response with a total daily dose of 160 to 320 mg given in two or three divided doses.

PARENTERAL:
-Initial: 75 mg IV infused over 5 hours once or twice daily based on the creatinine clearance.
-Maintenance: 75 to 300 mg infused over 5 hours once or twice daily based on the creatinine clearance.
-The dose may be increased in increments of 75 mg/day every 3 days. Doses as high as 225 or 300 mg IV have been utilized in patients with refractory life-threatening arrhythmias.
-Start IV therapy only if the baseline QT interval is less than 450 msec. During initiation and titration, monitor the QT interval after the completion of each infusion. If the QT interval prolongs to 500 msec or greater, reduce the dose, decrease the infusion rate, or discontinue the drug.

Use: Documented life-threatening ventricular arrhythmia

Many drugs can interact with sotalol AF. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with sotalol AF, especially:

• digoxin;

• insulin or oral diabetes medicine;

• blood pressure medication; or

• any other medicine that contains sotalol.

This list is not complete and many other drugs can interact with sotalol AF. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.