Generic Betapace

SOTALOL HCl
Tablets: 80, 120, 160 and 240 mg (Rx) Various, Betapace (Berlex)
80, 120, 160 mg (Rx)

Betapace - The recommended initial dose is 80 mg twice daily. This dose may be increased if necessary, after appropriate evaluation, to 240 or 320 mg/day (120 to 160 mg bid). In most patients, a therapeutic response is obtained at a total daily dost of 160 to 320 mg/day, given in 2 or 3 divided doses. Some patients with life-threatening refractory ventricular arrhythmias may require doses as high as 480 to 640 mg/day.
Adjust dosage gradually, allowing 3 days between dosing increments in order to attain steady-state plasma concentrations, and to allow monitoring of QT intervals.
Renal function impairment:
Dose escalations in renal impairment should be done after administration of at least 5 to 6 doses at appropriate intervals.
Exercise extreme caution in the use of sotalol in patients with renal failure undergoing hemodialysis. The half-life of sotalol is prolonged (< 69 hours) in anuric patients. However, sotalol can be partly removed by dialysis with subsequent partial rebound in concentrations when dialysis is completed. Safety (heart rate, QT interval) and efficacy (arrhythmia control) must be closely monitored.
Betapace AF - Therapy with Betapace AF must be initiated (and if necessary, titrated) in a setting that provides continuous ECG monitoring and in the presence of personnel trained in the management of serious ventricular arrhythmias. Continue to monitor patients in this way for a minimum of 3 days on the maintenance dose. In addition, do not discharge patients within 12 hours of electrical or pharmacological conversion to normal sinus rhythm.
The QT interval is used to determine patient eligibility for Betapace AF treatment and for monitoring safety during treatment. The baseline QT interval must be < 450 msec in order for a patient to be started on Betapace AF therapy. During initiation and titration, monitor the QT interval 2 to 4 hours after each dose. If the QT interval prolongs to > 500 msec, the dose must be reduced or the drug discontinued.
The dose of Betapace AF must be individualized according to creatinine clearance.
The recommended initial dose of Betapace AF is 80 mg and is initiated as shown in the dosing algorithm described below. The 80 mg dose can be titrated upward to 120 mg during initial hospitalization or after discharge on 80 mg in the event of recurrence, by rehospitalization and repeating the same steps used during the initiation of therapy.
Anticoagulate patients with atrial fibrillation according to usual medical practice. Correct hypokalemia before initiation of Betapace AF therapy.
Patients to be discharged on Betapace AF therapy from an inpatient setting should have an adequate supply of Betapace AF to allow uninterrupted therapy until the patient can fill a Betapace AF prescription.
Initiation of therapy:
1.) Electrocardiographic assessment: Prior to administration of the first dose, the QT interval must, be determined using an average of 5 beats. If the baseline QT is > 450 msec (JT > 330 msec if QRS over 100 msec), Betapace AF is contraindicated.
2.) Starting dose: The starting dose of Betapace AF is 80 mg twice daily if the creatinine clearance is > 60 mL/min, and 80 mg once daily if the creatinine clearance is 40 to 60 mL/min. If the creatinine clearance is < 40 mL/min, Betapace AF is contraindicated.
3.) Administer the appropriate daily dose of Betapace AF and begin continuous
ECG monitoring with QT interval measurements 2 to 4 hours after each dose.
4.) 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 is 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 the patient is receiving once daily doses).
Upward titration of dose: If the 80 mg dose level (given once or twice daily 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 (once or twice daily depending on 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. In a US multi-center dose-response study, a 120 mg dose (once or twice daily) was found to be the most effective in prolonging the time to ECG documented symptomatic recurrence of AFIB/AFL. 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 (once or twice daily depending on 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.
Maintenance of Betapace AF therapy: Regularly re-evaluate renal function and QT if medically warranted. If QT is > 520 msec (JT 430 msec or greater if QRS is > 100 msec), reduce the dose of Betapace AF therapy and carefully monitor patients until QT returns to < 520 msec. If the QT interval is > 520 msec while on the lowest maintenance dose level (80 mg), discontinue the drug. If renal function deteriorates, reduce the daily dose in half by administering the drug once daily as described in Initiation of Therapy, step 3.
Special considerations: The maximum recommended dose in patients with a calculated creatinine clearance > 60 mL/min is 160 mg twice/day, doses > 160 mg twice/ day have been associated with an increased incidence of torsades de pointes and are not recommended.
A patient who misses a dose should not double the next dose. The next dose should be taken at the usual time.
Transfer to sotalol from other antiarrhythmic therapy - Before starting sotalol, generally withdraw previous antiarrhythmic therapy under careful monitoring for a minimum of 2 to 3 plasma half-lives if the patient's clinical condition permits. Treatment has been initiated in some patients receiving IV lidocaine without ill effect. After discontinuation of amiodarone, do not initiate sotalol until the QT interval is normalized.
Transfer to Betapace AF from Betapace - Patients with a history of symptomatic atrial fibrillation/atrial flutter (AFIB/AFL) who are currently receiving Betapace for the maintenance of normal sinus rhythm should be transferred to Betapace AF because of the significant differences in labeling (i.e., patient package insert for Betapace AF, dosing, administration, and safety information).
CARDIO & BLOOD – CHOLESTEROL

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