NEODOSE

INDICATIONS

Treatment of refractory ventricular and supraventricular tachyarrhythmias

In adults, sotalol is indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia. Its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Avoid treatment of patients with asymptomatic ventricular premature contractions. In adults, sotalol is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)) in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Because sotalol can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB that is easily reversed (by Valsalva maneuver, for example) should usually not be given Betapace/Betapace AF

CONTRAINDICATIONS

Contraindicated in patients with sinus bradycardia, sick sinus syndrome, or second and third degree AV block (unless functioning pacemaker present), congenital or acquired long QT syndromes, cardiogenic shock or decompensated heart failure, serum potassium less than 4 mEq/L, bronchial asthma or related bronchospastic conditions. For the treatment of atrial fibrillation/flutter, contraindicated with baseline QT interval greater than 450 milliseconds or CrCl less than 40 mL/min

PRECAUTIONS

• Cardiovascular:
  • Serious and potentially fatal arrhythmias such as sustained ventricular tachycardia/fibrillation (VT/VF), primarily consisting of Torsade de Pointes (TdP), have been reported. Higher doses, reduced CrCl, female gender, reduced heart rate and history of sustained ventricular tachycardia/fibrillation have been associated with increased risk of TdP. Dose adjustments may be required. Correct hypokalemia or hypomagnesemia prior to therapy initiation.
  • Bradycardia or heart block may occur and increase the risk of Torsade de Pointes.
  • Significant hypotension may occur.
  • New onset or worsening heart failure may occur during initiation or dose increases. Discontinue treatment if symptoms develop.
  • Exacerbation of angina pectoris and myocardial infarction may occur with abrupt cessation of beta blocker therapy. Gradual dosage reduction recommended, especially in patients with ischemic heart disease.
• Concomitant Use:
  • Not recommended with drugs that prolong the QT interval.
• Endocrine and metabolic:
  • Hypokalemia or hypomagnesemia can exaggerate the degree of QT prolongation. Correct imbalances prior to use. Consider acid/base and electrolyte status in patients with severe or prolonged diarrhea or those receiving concomitant diuretics
  • Hyperglycemia may worsen and signs of hypoglycemia may be masked (eg, tachycardia) in patients with diabetes mellitus.
  • Exacerbation of hyperthyroidism, including thyroid storm, may occur upon abrupt withdrawal of beta blocker therapy in patients with thyroid disease. Avoid abrupt withdrawal. Additionally, beta blockade may mask signs of hyperthyroidism.
• Immunologic:
  • Beta-blocker therapy may cause patients with a history of an anaphylactic reaction to a variety of allergens to have a more severe allergic reaction on repeated challenge and to be unresponsive to usual doses of epinephrine.
• Respiratory:
  • Not recommended in patients with bronchospastic diseases. If use is required, dose adjustment is recommended
• Surgery:
  • Chronic beta-blocker therapy should not be routinely withdrawn prior to major surgery and anesthesia due to the impaired ability of the heart to respond to reflex adrenergic stimuli may augment risks of general anesthesia and surgical procedures

ADVERSE EFFECTS

Proarrhythmic effects occur in 10% of pediatric patients: sinoatrial block, A-V block, torsades de pointes and ventricular ectopic activity. These effects usually occur in the first few days of treatment. Prolongation of the QT interval is dose-dependent. Other adverse effects include fatigue, dyspnea, and hypotension.

BLACK BOX WARNING

To minimize the risk of drug-induced arrhythmia, initiate or reinitiate oral sotalol in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation. If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug. Calculate creatinine clearance to determine appropriate dosing.

MONITORING

Frequent EKG during initiation of therapy.