APO-SOTALOL

What it is

APO-SOTALOL contains sotalol hydrochloride and is available in tablet strengths of 80 mg or 160 mg. The 80 mg tablets are light blue, biconvex, capsule-shaped tablets engraved with 'S', '80' and a break bar, while the 160 mg tablets are light blue, biconvex, capsule-shaped tablets engraved with 'S', '160' and a break bar.

Approved indications

— Prevention and treatment of supraventricular arrhythmias — Prevention and treatment of ventricular arrhythmias

Dosing overview

APO-SOTALOL should be taken preferably 1–2 hours before meals. Oral dosage should be adjusted gradually allowing 2–3 days between dosing increments in order to attain steady-state and to allow monitoring of QT intervals. The recommended initial oral dosing schedule is 160 mg daily, given in two divided doses at approximately 12 hour intervals, which may be increased if necessary to 240 or 320 mg per day, with a therapeutic response obtained at a total daily dose of 160–320 mg per day in 2 divided doses in most patients. Some patients with life-threatening refractory ventricular arrhythmias may require doses as high as 480–640 mg per day; however, these doses should only be prescribed when the potential benefit outweighs the increased risk of adverse events particularly proarrhythmias. As sotalol is primarily excreted by the kidneys, dosage adjustment should be made in patients with impaired renal function.

Key safety warnings

No antiarrhythmic drug has been shown to reduce the incidence of sudden death in patients with supraventricular or asymptomatic ventricular arrhythmias, and since most antiarrhythmic drugs have the potential to cause proarrhythmias or increase the incidence of sudden death, physicians should carefully consider the risks and benefits of antiarrhythmic therapy in these patients. The most dangerous adverse effect of antiarrhythmic drugs is the aggravation of preexisting arrhythmias or the provocation of new arrhythmias, with drugs that prolong the QT interval able to cause torsades de pointes, a polymorphic ventricular tachycardia; experience indicates that the risk of torsades de pointes is associated with prolongation of the QT interval, reduction in heart rate, reduction in serum potassium and magnesium, high plasma drug concentrations, and concomitant use with other medications such as antidepressants and Class I antiarrhythmics. Females appear to be at increased risk of developing torsades de pointes. During clinical trials, 4.3% of 3257 patients with arrhythmias experienced a new or worsened ventricular arrhythmia, including sustained ventricular tachycardia (approximately 1%) and torsades de pointes (2.4%), and in approximately 1% of patients, deaths were considered possibly drug-related. Proarrhythmic events must be anticipated not only on initiating therapy but with every upward dose adjustment, and initiating therapy at 80 mg twice daily with gradual upward dose titration thereafter reduces the risk of proarrhythmia. Beta-blockade depresses myocardial contractility and may precipitate cardiac failure in some patients with a history of cardiac failure, chronic myocardial insufficiency, or unsuspected cardiomyopathy, and patients with congestive heart failure have a higher risk of torsade de pointes. APO-SOTALOL should not be used in patients with hypokalaemia or hypomagnesaemia prior to correction of imbalance, as these conditions can exaggerate the degree of QT prolongation and increase the potential for torsades de pointes, and serum electrolytes should be obtained prior to starting treatment and any electrolyte imbalance corrected. Care should be taken if beta-blockers have to be discontinued abruptly in patients with coronary artery disease, as hypersensitivity to catecholamines is observed in patients withdrawn from beta-blocker therapy, and severe exacerbation of angina pectoris and precipitation of myocardial infarction and ventricular arrhythmias have occurred following abrupt discontinuation.

Contraindications

Bronchospasm (such as bronchial asthma or chronic obstructive airway disease) and allergic disorders (including allergic rhinitis) which may suggest a predisposition to bronchospasm. Sinus bradycardia (less than 45–50 beats per minute) and second and third degree AV block or sick sinus syndrome unless a functioning pacemaker is present. Uncontrolled congestive heart failure, severe renal impairment (CrCl < 10 mL/min), and congenital or acquired long QT syndromes. Hypersensitivity to sotalol hydrochloride, other beta blockers, sulfonamides or the excipients. Hypomagnesaemia, hypotension and hypokalaemia.

PBS listing

The provided documents do not contain information about PBS listing for APO-SOTALOL.

Regulatory history

APO-SOTALOL sotalol hydrochloride 160 mg tablets were first listed on the ARTG on 6 June 2000, and the 80 mg formulation was first listed on the ARTG on 24 October 2002.