Sotalol Dosage

This dosage information may not include all the information needed to use Sotalol safely and effectively. See additional information for Sotalol.

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Atrial Fibrillation

Oral (Betapace AF):

Initial dose: 80 mg orally twice a day. Continuous ECG monitoring with QT interval measurements should begin after the first dose and every 2 to 4 hours after each additional dose.

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 the creatinine clearance) 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 the creatinine clearance).

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 the creatinine clearance), 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 of sotalol 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 intravenous sotalol 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.

Usual Adult Dose for Atrial Flutter

Oral (Betapace AF):

Initial dose: 80 mg orally twice a day. Continuous ECG monitoring with QT interval measurements should begin after the first dose and every 2 to 4 hours after each additional dose.

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 the creatinine clearance) 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 the creatinine clearance).

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 the creatinine clearance), 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 of sotalol 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 intravenous sotalol 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.

Usual Adult Dose for Ventricular Arrhythmia

Oral (Betapace):

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 intravenous sotalol 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.

Usual Pediatric Dose for Atrial Fibrillation

Baseline QTc interval and CrCl must be determined prior to initiation. Dosage should be adjusted to individual response and tolerance; doses should be initiated or increased in a hospital facility that can provide continuous ECG monitoring, recognition and treatment of life-threatening arrhythmias, and CPR.

Safety and efficacy in neonatal patients have not been established. Manufacturer dosing recommendations are based on doses per m2 (that are equivalent to the doses recommended in adults) and on pediatric pharmacokinetic and pharmacodynamic studies BSA, rather than body weight, better predicted apparent clearance of sotalol; however, for a given dose per m2, a larger drug exposure (larger AUC) and greater pharmacologic effects were observed in smaller subjects (i.e., those with BSA less than 0.33 m2 versus those with BSA greater than or equal to 0.33 m2). For infants and children less than or equal to 2 years of age, the manufacturer recommends a dosage reduction based on an age factor determined from a graph provided in the manufacturer insert.

Manufacturer's recommendations: Note: Use with extreme caution if QTc is greater than 500 msec while receiving sotalol; reduce the dose or discontinue drug if QTc is greater than 550 msec.

Infants and Children less than or equal to 2 years: The pediatric manufacturer recommended dosage of 30 mg/m2/dose must be REDUCED using an age-related factor that is obtained from the graph provided in the manufacturer insert. Use the graph to determine where the patient's age (on the logarithmic scale) intersects the age factor curve; read the age factor from the Y-axis; then multiply the age factor by the pediatric dose listed below (i.e., the dose for children greater than 2 years); this will result in the proper reduction in dose for age. For example, the age factor for an infant 1 month of age is 0.68, so the initial dosage would be (0.68 x 30 mg/m2/dose) = 20 mg/m2/dose given 3 times daily. Similar calculations should be made for dosage titrations; increase dosage gradually, if needed; allow adequate time between dosage increments to achieve new steady-state and to monitor clinical response, heart rate and QTc intervals; half-life is prolonged with decreasing age (less than 2 years), so time to reach new steady-state will increase.

2 years and older:
Initial: 30 mg/m2 orally 3 times a day; increase dosage gradually if needed; allow at least 36 hours between dosage increments to achieve new steady-state and to monitor clinical response, heart rate, and QTc intervals; may increase gradually to a maximum of 60 mg/m2/dose given 3 times daily.

Alternative pediatric dosing:
Initial: 2 mg/kg/day divided every 8 hours; if needed, increase dosage gradually by 1 to 2 mg/kg/day increments; allow 3 days between dosage increments to achieve new steady-state and to monitor clinical response, heart rate, and QTc intervals; maximum: 10 mg/kg/day (if no limiting side effects occur); do not exceed adult doses.
Proposed required doses: Note: It is not necessary to increase to required dosage if desired clinical effect has been achieved at a lower dosage.
Infants and Children 1 month to 6 years: 6 mg/kg/day divided every 8 hours
Children greater than 6 years: 4 mg/kg/day divided every 8 hours

Usual Pediatric Dose for Atrial Flutter

Baseline QTc interval and CrCl must be determined prior to initiation. Dosage should be adjusted to individual response and tolerance; doses should be initiated or increased in a hospital facility that can provide continuous ECG monitoring, recognition and treatment of life-threatening arrhythmias, and CPR.

Safety and efficacy in neonatal patients have not been established. Manufacturer dosing recommendations are based on doses per m2 (that are equivalent to the doses recommended in adults) and on pediatric pharmacokinetic and pharmacodynamic studies BSA, rather than body weight, better predicted apparent clearance of sotalol; however, for a given dose per m2, a larger drug exposure (larger AUC) and greater pharmacologic effects were observed in smaller subjects (i.e., those with BSA less than 0.33 m2 versus those with BSA greater than or equal to 0.33 m2). For infants and children less than or equal to 2 years of age, the manufacturer recommends a dosage reduction based on an age factor determined from a graph provided in the manufacturer insert.

Manufacturer's recommendations: Note: Use with extreme caution if QTc is greater than 500 msec while receiving sotalol; reduce the dose or discontinue drug if QTc is greater than 550 msec.

Infants and Children less than or equal to 2 years: The pediatric manufacturer recommended dosage of 30 mg/m2/dose must be REDUCED using an age-related factor that is obtained from the graph provided in the manufacturer insert. Use the graph to determine where the patient's age (on the logarithmic scale) intersects the age factor curve; read the age factor from the Y-axis; then multiply the age factor by the pediatric dose listed below (i.e., the dose for children greater than 2 years); this will result in the proper reduction in dose for age. For example, the age factor for an infant 1 month of age is 0.68, so the initial dosage would be (0.68 x 30 mg/m2/dose) = 20 mg/m2/dose given 3 times daily. Similar calculations should be made for dosage titrations; increase dosage gradually, if needed; allow adequate time between dosage increments to achieve new steady-state and to monitor clinical response, heart rate and QTc intervals; half-life is prolonged with decreasing age (less than 2 years), so time to reach new steady-state will increase.

2 years and older:
Initial: 30 mg/m2 orally 3 times a day; increase dosage gradually if needed; allow at least 36 hours between dosage increments to achieve new steady-state and to monitor clinical response, heart rate, and QTc intervals; may increase gradually to a maximum of 60 mg/m2/dose given 3 times daily.

Alternative pediatric dosing:
Initial: 2 mg/kg/day divided every 8 hours; if needed, increase dosage gradually by 1 to 2 mg/kg/day increments; allow 3 days between dosage increments to achieve new steady-state and to monitor clinical response, heart rate, and QTc intervals; maximum: 10 mg/kg/day (if no limiting side effects occur); do not exceed adult doses.
Proposed required doses: Note: It is not necessary to increase to required dosage if desired clinical effect has been achieved at a lower dosage.
Infants and Children 1 month to 6 years: 6 mg/kg/day divided every 8 hours
Children greater than 6 years: 4 mg/kg/day divided every 8 hours

Usual Pediatric Dose for Ventricular Arrhythmia

Baseline QTc interval and CrCl must be determined prior to initiation. Dosage should be adjusted to individual response and tolerance; doses should be initiated or increased in a hospital facility that can provide continuous ECG monitoring, recognition and treatment of life-threatening arrhythmias, and CPR.

Safety and efficacy in neonatal patients have not been established. Manufacturer dosing recommendations are based on doses per m2 (that are equivalent to the doses recommended in adults) and on pediatric pharmacokinetic and pharmacodynamic studies BSA, rather than body weight, better predicted apparent clearance of sotalol; however, for a given dose per m2, a larger drug exposure (larger AUC) and greater pharmacologic effects were observed in smaller subjects (i.e., those with BSA less than 0.33 m2 versus those with BSA greater than or equal to 0.33 m2). For infants and children less than or equal to 2 years of age, the manufacturer recommends a dosage reduction based on an age factor determined from a graph provided in the manufacturer insert.

Manufacturer's recommendations: Note: Use with extreme caution if QTc is greater than 500 msec while receiving sotalol; reduce the dose or discontinue drug if QTc is greater than 550 msec.

Infants and Children less than or equal to 2 years: The pediatric manufacturer recommended dosage of 30 mg/m2/dose must be REDUCED using an age-related factor that is obtained from the graph provided in the manufacturer insert. Use the graph to determine where the patient's age (on the logarithmic scale) intersects the age factor curve; read the age factor from the Y-axis; then multiply the age factor by the pediatric dose listed below (i.e., the dose for children greater than 2 years); this will result in the proper reduction in dose for age. For example, the age factor for an infant 1 month of age is 0.68, so the initial dosage would be (0.68 x 30 mg/m2/dose) = 20 mg/m2/dose given 3 times daily. Similar calculations should be made for dosage titrations; increase dosage gradually, if needed; allow adequate time between dosage increments to achieve new steady-state and to monitor clinical response, heart rate and QTc intervals; half-life is prolonged with decreasing age (less than 2 years), so time to reach new steady-state will increase.

2 years and older:
Initial: 30 mg/m2 orally 3 times a day; increase dosage gradually if needed; allow at least 36 hours between dosage increments to achieve new steady-state and to monitor clinical response, heart rate, and QTc intervals; may increase gradually to a maximum of 60 mg/m2/dose given 3 times daily.

Alternative pediatric dosing:
Initial: 2 mg/kg/day divided every 8 hours; if needed, increase dosage gradually by 1 to 2 mg/kg/day increments; allow 3 days between dosage increments to achieve new steady-state and to monitor clinical response, heart rate, and QTc intervals; maximum: 10 mg/kg/day (if no limiting side effects occur); do not exceed adult doses.
Proposed required doses: Note: It is not necessary to increase to required dosage if desired clinical effect has been achieved at a lower dosage.
Infants and Children 1 month to 6 years: 6 mg/kg/day divided every 8 hours
Children greater than 6 years: 4 mg/kg/day divided every 8 hours

Renal Dose Adjustments

Adults:

Oral (Betapace):

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):

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

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).

The manufacturer recommends that the patient be placed for a minimum of three days in a facility that can provide cardiac resuscitation, continuous electrocardiographic monitoring and calculations of creatinine clearance when initiating sotalol for the treatment of atrial fibrillation.

Safety and effectiveness of parenteral sotalol have not been established in pediatric patients (less than 18 years of age).

Dialysis

Extreme caution is warranted in patients undergoing hemodialysis. Sotalol can be partly removed by dialysis but subsequent partial rebound in levels can occur when dialysis is completed.

Other Comments

A therapeutic response is attained in most patients at a dose of 160 to 320 mg/day. Doses greater than 160 mg twice daily have been associated with an increased incidence of Torsades de Pointes.

Intravenous sotalol must be diluted prior to infusion. Appropriate diluents are saline, 5% dextrose in water (D5W), or Ringers lactate. Usual volume prepared is 100 to 250 mL. A volumetric infusion pump should be used to infuse sotalol at a constant rate.

Parenteral sotalol can substitute for oral sotalol in patients who are unable to take sotalol orally.

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