What are the protocols for using Sotalol (beta blocker and anti-arrhythmic medication)?

From the Guidelines

Sotalol should be initiated in a monitored setting due to its risk of QT prolongation and life-threatening arrhythmias, with a recommended starting dose of 80 mg twice daily for adults with normal renal function, as supported by the most recent guidelines 1. When using sotalol, it is essential to consider the patient's renal function, as dose adjustments are necessary based on creatinine clearance.

• For patients with creatinine clearance 30-60 mL/min, the dose should be reduced to 80 mg once daily.
• For patients with creatinine clearance <30 mL/min, the dose should be further reduced to 80 mg every 36-48 hours. Before starting sotalol, baseline ECG, electrolytes, and renal function tests should be obtained, and patients should be monitored with continuous ECG for at least 3 doses or 3 days.
• Therapy should be discontinued if QTc exceeds 500 ms or increases by >60 ms from baseline. It is also crucial to maintain potassium levels above 4.0 mEq/L and magnesium above 2.0 mg/dL, and avoid concomitant use of other QT-prolonging medications, as sotalol works as both a beta-blocker and a potassium channel blocker (Class III antiarrhythmic), making it effective for both atrial and ventricular arrhythmias but also increasing the risk of torsades de pointes, particularly at higher doses or with electrolyte abnormalities 1. Patients should be educated about symptoms of arrhythmias and instructed to report dizziness, palpitations, or syncope immediately, highlighting the importance of close monitoring and patient education when using sotalol 1.

From the FDA Drug Label

Patients should continue to be monitored in this way for a minimum of 3 days on the maintenance dose. The dose of Sotalol AF must be individualized according to calculated creatinine clearance In patients with a creatinine clearance >60 mL/min Sotalol AF is administered twice daily (BID) while in those with a creatinine clearance between 40 and 60 mL/min, the dose is administered once daily (QD). The recommended initial dose of Sotalol AF is 80 mg and is initiated as shown in the dosing algorithm described below. Initiation of Sotalol AF Therapy Step 1. Electrocardiographic assessment: Prior to administration of the first dose, the QT interval must be determined using an average of 5 beats Step 2 Calculation of creatinine clearance: Prior to the administration of the first dose, the patient's creatinine clearance should be calculated Step 3. Starting Dose: The starting dose of Sotalol AF is 80 mg twice daily (BID) if the creatinine clearance is >60 mL/min, and 80 mg once daily (QD) if the creatinine clearance is 40 to 60 mL/min. Step 4 Administer the appropriate daily dose of Sotalol AF and begin continuous ECG monitoring with QT interval measurements 2 to 4 hours after each dose. Step 5. If the 80 mg dose level is tolerated and the QT interval remains <500 msec after at least 3 days (after 5 or 6 doses if patient receiving QD dosing), the patient can be discharged

The protocols for using sotalol involve:

• Initiation of therapy in a hospital setting with monitoring of QT interval and creatinine clearance
• Individualized dosing based on creatinine clearance, with an initial dose of 80 mg
• ECG monitoring with QT interval measurements 2 to 4 hours after each dose
• Dose titration as needed, with careful monitoring of QT interval and clinical response
• Maintenance therapy with regular monitoring of renal function and QT interval 2
• Special considerations for children, including initiation of treatment in the hospital, individualized regimen, and careful monitoring of QTc interval and heart rate 2

From the Research

Protocols for Using Sotalol

• The current recommended starting dose of sotalol is 80 mg orally twice per day, followed by a judicious increase in dosage every 3 days under continuous telemetry monitoring 3.
• An accelerated dosing regimen of sotalol, initiating at 120-160 mg orally twice per day, may marginally increase the risk of cardiac and non-cardiac side effects compared to the standard starting regimen of 80 mg twice per day 3.
• An accelerated titration regimen of sotalol can shorten the time to attain the dosage usually required to effectively control arrhythmias, without excessive QT prolongation and the associated increased risk of torsades de pointes 4.

Safety Evaluation

• Sotalol is effective for treating atrial fibrillation, ventricular tachycardia, premature ventricular contractions, and supraventricular tachycardia, but there is a near linear relationship between sotalol dosage and QT interval prolongation 5.
• The risk of QT interval prolongation and torsades de pointes is increased in patients with heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF) compared to those without heart failure 6.
• Pharmacists play an important role in minimizing the risk of drug-induced QTc interval prolongation and torsades de pointes through knowledge of drugs that are associated with a known or possible risk of torsades de pointes, individualized assessment of risk of drug-induced QTc interval prolongation, and awareness of drug interactions most likely to result in torsades de pointes 7.

Dosage and Administration

• Orally administered sotalol has a bioavailability of nearly 100%, and the only significant drug interactions are the need to avoid or limit use of concomitant drugs that cause QT prolongation, bradycardia, and/or hypotension 5.
• The target prolongation of QTc (90% of the value achieved at steady state) was achieved 22 1/2 hours sooner with the accelerated titration regimen compared to the standard titration regimen 4.