Sotalol

Use caution with history of severe anaphylaxis to allergens; patients taking beta-blockers may become more sensitive to repeated challenges. Treatment of anaphylaxis (eg, epinephrine) in patients taking beta-blockers may be ineffective or promote undesirable effects.

May cause bradycardia (including heart block) and hypotension. Dose adjustments of agents that slow AV nodal conduction may be necessary when sotalol is initiated.

Sotalol can cause life-threatening ventricular tachycardia associated with QT interval prolongation (ie, torsades de pointes). Do not initiate if baseline QTc interval is >450 msec (Betapace/Betapace AF, Sotylize, or sotalol injection). If QTc interval prolongs to 500 msec or exceeds 500 msec during therapy, reduce the dose, prolong the interval between doses, prolong the duration of the infusion (sotalol injection), or discontinue use (Betapace/Betapace AF, Sotylize, sotalol injection). Adjust the dosing interval based on creatinine clearance (CrCl). QTc prolongation is directly related to the concentration of sotalol; reduced CrCl, female gender, reduced heart rate, and large doses increase the risk of QTc prolongation and subsequent torsades de pointes. Patients initiated or reinitiated on sotalol or sotalol AF and patients who are converted from IV to oral administration should be placed for a minimum of 3 days (on their maintenance dose) in a facility that can provide cardiac resuscitation and continuous electrocardiographic (ECG) monitoring. Some experts will initiate oral therapy on an outpatient basis if the patient is in sinus rhythm provided the QT interval and serum potassium are normal and the patient is not receiving any other QT-interval prolonging medications but require inpatient hospitalization if the patient is in atrial fibrillation (AHA/ACC/HRS [January 2014]). Calculation of CrCl must occur prior to administration of the first dose. Dosage should be adjus

In general, patients with bronchospastic disease should not receive beta-blockers; if used at all, should be used cautiously with close monitoring. Sotalol is contraindicated in patients with bronchial asthma or related bronchospastic conditions.

Consider preexisting conditions such as sick sinus syndrome before initiating.

Use with caution in patients with diabetes mellitus; may potentiate hypoglycemia and/or mask signs and symptoms.

Correct electrolyte imbalances before initiating (especially hypokalemia and hypomagnesemia) because these conditions increase the risk of torsades de pointes.

New onset or worsening heart failure may occur during initiation or titration. Use with caution in patients with compensated heart failure; monitor for a worsening of the condition and discontinue if symptoms of heart failure occur. Use is contraindicated in patients with uncontrolled (or decompensated) heart failure.

Use with caution in patients with myasthenia gravis; may worsen disease.

Use with caution within the first 2 weeks post-MI, especially in patients with markedly impaired ventricular function (experience limited).

Can precipitate or aggravate symptoms of arterial insufficiency in patients with PVD and Raynaud disease. Use with caution and monitor for progression of arterial obstruction.

Adequate alpha-blockade is required prior to use of any beta-blocker.

Use with caution in patients with a history of psychiatric illness; may cause or exacerbate CNS depression.

Adjust dosing interval based on CrCl to decrease risk of proarrhythmia; QT interval prolongation is directly related to sotalol concentration. CrCl must be calculated with dose initiation and dose increases. The use of sotalol is contraindicated in patients with CrCl • Thyroid disease: May mask signs of hyperthyroidism (eg, tachycardia). If thyrotoxicosis is suspected, carefully manage and monitor; abrupt withdrawal may exacerbate symptoms of hyperthyroidism or precipitate thyroid storm. Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

Bradycardia may be observed more frequently in elderly patients (>65 years of age); dosage reductions may be necessary. Dosage form specific issues:

Oral: [US Boxed Warning]: Sotalol is indicated for both the treatment of documented life-threatening ventricular arrhythmias (marketed as Betapace/Betapace AF, Sorine, and Sotylize) and for the maintenance of normal sinus rhythm in patients with symptomatic atrial fibrillation/flutter who are currently in sinus rhythm (marketed as Betapace/Betapace AF and Sotylize). Sorine should not be substituted for sotalol AF. Other warnings/precautions:

Beta-blocker therapy should not be withdrawn abruptly (particularly in patients with CAD), but gradually tapered to avoid acute tachycardia, hypertension, and/or ischemia. Severe exacerbation of angina, ventricular arrhythmias, and myocardial infarction (MI) have been reported following abrupt withdrawal of beta-blocker therapy. Temporary but prompt resumption of beta-blocker therapy may be indicated with worsening of angina or acute coronary insufficiency. When QTc prolongation occurs, consider weighing the risk of abrupt withdrawal of sotalol with the risk of QTc prolongation. Use of an alternative beta-blocker may be indicated if worsening angina or acute coronary insufficiency occurs when sotalol is withdrawn abruptly due to QTc prolongation.

Chronic beta-blocker therapy should not be routinely withdrawn prior to major surgery.