Sotalol

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1. Prior to administration of the first dose, the QT interval must be determined using an average of 5 beats. If the baseline QT is greater than 450 msec (JT >330 msec if QRS over 100 msec), BETAPACE AF™ is contraindicated.
2. Prior to the administration of the first dose, the patient's creatinine clearance should be calculated.
3. The starting dose of BETAPACE 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 40-60 mL/min. If the creatinine clearance is <40 mL/min BETAPACE AF™ is contraindicated. Patients with atrial fibrillation should be anticoagulated according to usual medical practice. Hypokalemia should be corrected before initiation of BETAPACE AF™ therapy (See Warnings, Ventricular Arrhythmia).
4. Administer the appropriate daily dose of BETAPACE AF™ and begin continuous ECG monitoring with QT interval measurements 2-4 hours after each dose. 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. Alternatively, during hospitalization, the dose can be increased to 120 mg BID and the patient followed for 3 days on this dose (followed for 5 or 6 doses if patient receiving QD doses). If the 80 mg dose level (given BID or QD depending upon the creatinine clearance) does not reduce the frequency of relapses of AFIB/AFL and is tolerated without excessive QT interval prolongation (i.e. >520 msec), the dose level may be increased to 120 mg (BID or QD depending upon the creatinine clearance). As proarrhythmic events can occur not only at initiation of therapy, but also with each upward dosage adjustment, Steps 2 through 5 used during initiation of BETAPACE AF™ therapy should be followed when increasing the dose level. If the 120 mg dose does not reduce the frequency of early relapse of AFIB/AFL and is tolerated without excessive QT interval prolongation (>520 msec), an increase to 160 mg (BID or QD depending upon the creatinine clearance), can be considered. Steps 2 through 5 used during the initiation of therapy should be used again to introduce such an increase.
5. Renal function and QT should be re-evaluated regularly if medically warranted. If QT is 520 msec or greater (JT 430 msec or greater if QRS is >100 msec), the dose of BETAPACE AF™ therapy should be reduced and patients should be carefully monitored until QT returns to less than 520 msec. If the QT interval is >520 msec while on the lowest maintenance dose level (80 mg) the drug should be discontinued. If renal function deteriorates, reduce the daily dose in half by administering the drug once daily as described in Initiation of BETAPACE AF™ Therapy, Step 3.

Other Sotalol Articles

• Initiating sotalol at 120–160 mg orally twice per day marginally increases the risk of cardiac and non-cardiac side effects compared to the standard starting regimen of 80 mg b.i.d. Such an accelerated dosing regimen neither shortened hospitalization nor had any effect on treatment efficacy in this retrospective analysis. (PACE 2006; 29:1219–1225)