SOTALOL HYDROCHLORIDE 
Pronounciation
Trade Name(s)
- Beta-adrenergic blocking agent
Baseline ECG indicated; see Monitor.
To minimize the risk of induced arrhythmia, patients initiated or re-initiated on sotalol and patients who are converted from IV to oral administration should be hospitalized in a facility that can provide cardiac resuscitation and continuous ECG monitoring. CrCl must be greater than 60 mL/min. Baseline studies and correction of electrolyte abnormalities required before initiating therapy; see Precautions, Monitor, and Dose Adjustments.
75 mg twice daily. If symptomatic arrhythmia is not controlled and dose is tolerated without excessive QTc prolongation (i.e., greater than 500 msec), may increase dose to 112.5 mg twice daily after 3 days. Continuous ECG monitoring required during dose escalation.
Dose for ventricular arrhythmias:
75 mg twice daily. Dose may be increased in increments of 75 mg/day every 3 days. Usual therapeutic effect is seen with doses of 75 to 150 mg twice daily. However, doses as high as 225 to 300 mg have been required in patients with refractory life-threatening arrhythmias.
Dose for symptomatic atrial fibrillation/atrial flutter (AFIB/AFL):
112.5 mg twice daily was found to be the most effective dose in studies. If symptomatic arrhythmia is not controlled and this dose is tolerated without excessive QTc prolongation (i.e., greater than 520 msec), increase dose to 150 mg twice daily.
Conversion from oral to IV Sotalol:
Patients who have been stabilized on oral sotalol and are unable to take oral medications may be converted to IV sotalol using the following conversion chart.
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Increase dosing interval to every 24 hours in patients with a CrCl between 40 and 60 mL/min. Sotalol is not recommended in patients with a CrCl less than 40 mL/min.
■ Titrate dose upward or downward as needed based on clinical effect, QT interval, or adverse reactions as described in Usual Dose.
Available in vials containing 150 mg/10 mL. Dilute required dose with NS, D5W, or LR as described in the following chart.
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Store at CRT. Protect from light and freezing.
An antiarrhythmic with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. The beta-blocking effect is noncardioselective. Slows heart rate, decreases AV nodal conduction, and increases AV nodal refractoriness. ECG shows dose-related increase in QT and QTc. Produces a reduction in systolic and diastolic BP and cardiac index and an increase in pulmonary capillary wedge pressure. Does not bind to plasma proteins and is not metabolized. Half-life is 12 hours. Excreted predominantly via the kidney in unchanged form. Crosses the placenta. Secreted in breast milk.
A substitute for oral sotalol in patients who are unable to take oral medications.
■ Maintenance of normal sinus rhythm in patients with a history of highly symptomatic AFIB/AFL.
■ Treatment of documented life-threatening ventricular arrhythmias.
Bradycardia (HR below 50 beats/min), sick sinus syndrome, or second- or third-degree AV block unless a functioning pacemaker is present.
■ Congenital or acquired long QT syndromes, QT interval greater than 450 msec.
■ Cardiogenic shock, uncontrolled heart failure.
■ CrCl less than 40 mL/min.
■ Serum potassium less than 4 mEq/L.
■ Bronchial asthma or related bronchospastic conditions.
■ Known hypersensitivity to sotalol.
To minimize the risk of induced arrhythmia, patients initiated or re-initiated on sotalol and patients who are converted from IV to oral administration should be hospitalized for at least 3 days (or until steady-state drug levels are reached) in a facility that can provide cardiac resuscitation and continuous ECG monitoring. Personnel trained in the management of serious ventricular arrhythmias must be present.
■ Can cause serious ventricular arrhythmias, primarily torsades de pointes (TdP), a polymorphic ventricular tachycardia associated with QTc prolongation. QTc prolongation is directly related to the concentration of sotalol. Factors that may increase the risk of TdP include a reduced CrCl, larger doses, female gender, sustained VT, and a history of cardiomegaly or CHF.
■ The use of sotalol in conjunction with other drugs that prolong the QT interval has not been studied and is not recommended; see Drug/Lab Interactions.
■ May cause bradycardia, which increases risk of TdP.
■ Increased risk of TdP in patients with AFIB and sinus node dysfunction, especially after cardioversion. Sotalol increases bradycardia and QTc following cardioversion.
■ Produces significant reductions in both systolic and diastolic BP. May cause deterioration in cardiac performance in patients with marginal cardiac compensation.
■ Use caution in CHF. Beta blockade may depress myocardial contractility and precipitate or exacerbate heart failure.
■ Use caution in the presence of heart failure controlled by digoxin. Both drugs slow AV conduction.
■ Experience with use following acute MI is limited. Use caution, titrate dose carefully, and monitor patient closely.
■ May cause angina, arrhythmia, or MI if discontinued abruptly; gradually reduce over 1 to 2 weeks if possible.
■ May mask tachycardia occurring with hypoglycemia in diabetes and tachycardia of hyperthyroidism.
■ In general, patients with bronchospastic disease should not receive beta-blockers. If sotalol is to be administered, use the smallest effective dose; see Contraindications.
■ Use caution in patients with renal impairment; see Dose Adjustments.
■ Patients with atrial fibrillation should be anticoagulated according to usual medical practice.
Obtain baseline ECG to determine the QT interval. If baseline QT interval is greater than 450 msec, sotalol is not recommended. Monitor QT interval after the completion of each infusion.
■ Measure and normalize serum potassium and magnesium levels before initiating therapy and as required during therapy. Pay special attention to electrolytes and acid-base status in patients with prolonged diarrhea or in patients receiving concomitant diuretics.
■ Obtain baseline SCr and calculate CrCl to establish dosing interval.
■ Monitor HR and BP. Monitor hemodynamics in patients with marginal cardiac compensation.
■ In patients with life-threatening ventricular arrhythmias, the response to treatment should be evaluated by a suitable method (e.g., programmed electrical stimulation [PES] or Holter monitoring) at steady-state blood levels of the drug before continuing the patient on chronic therapy.
Do not discontinue therapy abruptly.
■ Promptly report any breathing difficulty, syncope, or pain at injection site.
Category B: use during pregnancy only if clearly needed.
■ Discontinue breast-feeding.
■ Safety for use in pediatric patients not established. See prescribing information for unlabeled suggested oral doses for use in pediatric patients.
Age-related differences in safety and effectiveness not identified; however, greater sensitivity of some elderly cannot be ruled out. Dose with caution, taking into account decreased renal function; see Dose Adjustments.
Proarrhythmic events were more common in sotalol-treated patients also receiving digoxin. Unclear as to whether this is a drug interaction or is related to the presence of heart failure, which is a known risk factor for arrhythmias.
■ Concurrent use with calcium channel blockers is expected to have additive effects on AV conduction, ventricular function, and BP.
■ Beta-adrenergic blocking agents may be continued during the perioperative period in most patients; however, use caution with selected anesthetic agents that may depress the myocardium. Protracted severe hypotension and difficulty in restoring and maintaining normal cardiac rhythm after anesthesia have been reported.
■ Concurrent use with clonidine may precipitate acute hypertension if one or both agents are stopped abruptly.
■ Coadministration with catecholamine-depleting drugs (e.g., reserpine and guanethidine) may result in hypotension, bradycardia, vertigo, syncope, or orthostatic hypotension.
■ Hyperglycemia may occur. Dosage of insulin and other antidiabetic drugs may require adjustment.
■ Symptoms of hypoglycemia may be masked.
■ Increased doses of beta-agonists such as albuterol, terbutaline, and isoproterenol may be required when administered concomitantly with sotalol.
■ Patients taking beta-blockers who are exposed to a potential allergen may be unresponsive to the usual dose of epinephrine used to treat a hypersensitivity reaction.
■ The use of sotalol in conjunction with other drugs that prolong the QT interval has not been studied and is not recommended. Such drugs include some phenothiazines, tricyclic antidepressants, oral macrolide antibiotics, Class I antiarrhythmics (e.g., disopyramide, procainamide, quinidine), and Class III antiarrhythmics (e.g., amiodarone). Class I and III antiarrhythmic agents should be withheld for at least three half-lives before dosing with sotalol.
■ The presence of sotalol in the urine may result in falsely elevated levels of urinary metanephrine by certain methods.
There is no clinical experience with IV sotalol. Side effects should be similar to those seen with oral sotalol therapy. The most common side effects (dose related) are asthenia, bradycardia, chest pain, dizziness, dyspnea, fatigue, headache, light-headedness, nausea, palpitations, and QT prolongation. Ventricular arrhythmia, primarily TdP, is the most common serious side effect. Other reported side effects include abdominal distension and pain, abnormal ECG, angina, bradycardia, cough, decreased appetite, diarrhea, dyspepsia, edema, fever, heart failure, hyperhidrosis, hypotension, infection, insomnia, musculoskeletal pain, tracheobronchitis, upper respiratory infection, visual disturbance, vomiting, and weakness. Other reactions have been reported.
Bradycardia, bronchospasm, cardiac asystole, CHF, hypoglycemia, hypotension, premature ventricular complexes, prolongation of the QT interval, TdP, and ventricular arrhythmia.
Notify physician of any side effects. If the QT interval increases to 500 msec or greater, reduce the dose, decrease the infusion rate, or discontinue therapy. Atropine, another anticholinergic drug, a beta-adrenergic agonist, or transvenous cardiac pacing may be used to treat bradycardia or cardiac asystole. A transvenous cardiac pacemaker may be required for second- or third-degree heart block. Epinephrine may be useful for treatment of hypotension. Aminophylline or aerosol beta-2–receptor stimulants (e.g., albuterol) may be useful for treatment of bronchospasm. DC cardioversion, magnesium sulfate, and potassium replacement may be required for treatment of TdP. Once TdP is terminated, transvenous cardiac pacing or an isoproterenol infusion may be used to increase heart rate.