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

Renal Dose Adjustments

Adults:
Oral [Betapace(R)]:

• CrCl less than 10 mL/min: Dose should be individualized
• CrCl 10 to 29 mL/min: The dosage interval should be increased to 36 to 48 hours.
• CrCl 30 to 59 mL/min: The dosage interval should be increased to 24 hours.
• CrCl greater than 60 mL/min: The dosage interval should be decreased to 12 hours.

Oral [Betapace AF (R)]:

• CrCl less than 40 mL/min: Contraindicated
• CrCl 40 to 60 mL/min: 80 mg every 24 hours

Parenteral:

• CrCl less than 40 mL/min: Contraindicated
• CrCl 40 to 60 mL/min: The dosage interval should be once daily
• CrCl greater than 60 mL/min: The dosage interval should be twice daily

Children: Betapace/Betapace AF/Sotalol intravenous: Data not available

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Dose adjustments should be done gradually allowing 2 to 3 days between dosing increments.

Precautions

US BOXED WARNING:

• LIFE-THREATENING PROARRHYTHMIA: This drug can cause life threatening ventricular tachycardia associated with QT interval prolongation. Do not initiate therapy if the baseline QTc is longer than 450 ms. If the QT interval prolongs to 500 ms or greater, the dose should be reduced, the duration of the infusion prolonged or the drug discontinued. The patient should be hospitalized in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. The dosing interval should be adjusted based on creatinine clearance.

This drug has not been studied in pediatric patients (under 18 years of age). Consult the manufacturer product information and/or local protocol for theoretical dosing based on body surface area.

Consult WARNINGS section for additional precautions.

Dialysis

Extreme caution should be exercised in patients with renal failure undergoing hemodialysis. The half-life of this drug is prolonged (up to 69 hours) in anuric patients. However, this drug can be partly removed by dialysis with subsequent partial rebound in concentrations when dialysis is completed. Both safety (heart rate, QT interval) and efficacy (arrhythmia control) should be closely monitored.

Other Comments

Sotalol is available as the trade name Betapace and Betapace AF. These two trade names have different indications and one product should never be substituted for the other product because of significant differences in labeling (i.e., indications, dosing administration, safety information, and patient package insert information).

Administration advice:

• This drug should be given 1 to 2 hours before food.
• Dosing on more than a twice daily regimen is not usually necessary.

Patient advice:

• Patients should be instructed NOT to double the next dose if a dose is missed. The next dose should be taken at the usual time.

Frequently asked questions

• What is the difference between Sotalol and Sotalol AF?