Composition
Each Sotaloc® tablet contains 160 mg of sotalol hydrochloride
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Indications
Life-Threatening Ventricular Arrhythmias
Sotaloc® is indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT).
Delay In Recurrence Of Atrial Fibrillation/Atrial Flutter (AFIB/AFL)
Sotaloc® is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of AFIB/AFL) in patients with symptomatic AFIB/AFL who are currently in sinus rhythm.
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Dosage
Dose For Ventricular Arrhythmias
The recommended initial dose is 80 mg twice daily. This dose may be increased in increments of 80 mg per day every 3 days provided the QTc < 500 msec. Continually monitor patients until steady state blood levels are achieved. In most patients, a therapeutic response is obtained at a total daily dose of 160 to 320 mg/day, given in two or three divided doses (because of the long terminal elimination half-life of sotalol, dosing more than a two times a day is usually not necessary). Oral doses as high as 480-640 mg/day have been utilized in patients with refractory life-threatening arrhythmias.
Dose For Prevention Of Recurrence Of AFIB/AFL
The recommended initial dose is 80 mg twice daily. This dose may be increased in increments of 80 mg perday every 3 days provided the QTc < 500 msec. Continually monitor patients until steady state blood levels are achieved. Most patients will have satisfactory response with 120 mg twice daily. Initiation of sotalol in patients with creatinine clearance < 40 ml/min or QTc > 450 is contraindicated.
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How Supplied
Boxes of 1, 2, 3, 5 or 10 (Al/colorless PVC) strips, each strip
contains 10 tablets.
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Clinical Pharmacology
Sotaloc® (sotalol hydrochloride) has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. Sotaloc® (sotalol
hydrochloride) is a racemic mixture of d- and l- sotalol. Both isomers have similar Class III antiarrhythmic effects, while the l-isomer is responsible for virtually all of the beta-blocking activity. The beta-blocking effect of sotalol is
non-cardioselective, half maximal at about 80 mg/day and maximal at doses between 320 and 640 mg/day. Sotalol
does not have partial agonist or membrane stabilizing activity. Although significant beta-blockade occurs at oral doses as low as 25 mg, significant Class III efects are seen only at daily doses of 160 mg and above.
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