SOLAVERT

What it is

SOLAVERT contains sotalol hydrochloride and is available in tablet strengths of 80 mg or 160 mg.

Approved indications —

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

Dosing overview

The recommended initial oral dosing is 160 mg daily, given in two divided doses at approximately 12 hour intervals. This dose may be increased, if necessary, to 240 or 320 mg per day. In most patients, a therapeutic response is obtained at a total daily dose of 160–320 mg per day, given in two divided doses. 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. Oral dosage of SOLAVERT should be adjusted gradually, allowing 2–3 days between dosing increments in order to attain steady-state and to allow monitoring of QT intervals. As sotalol is primarily excreted by the kidneys, a 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. 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. Drugs that prolong the QT interval may cause torsades de pointes, a polymorphic ventricular tachycardia associated with prolongation of the QT interval. The risk of torsades de pointes is associated with the prolongation of the QT interval, reduction in heart rate, reduction in serum potassium and magnesium (such as a consequence of diuretic use), high plasma drug concentrations (such as a consequence of overdosage or renal insufficiency), and with the concomitant use of sotalol and other medication such as antidepressants and Class 1 antiarrhythmics which have been associated with torsades de pointes. Females appear to be at increased risk of developing torsades de pointes. During clinical trials, 4.3 per cent of 3257 patients with arrhythmias experienced a new or worsened ventricular arrhythmia, including sustained ventricular tachycardia (approximately 1 per cent) and torsades de pointes (2.4 per cent). In addition, in approximately 1 per cent of patients, deaths were considered possibly drug-related. Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure, and 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. Moreover, patients with congestive heart failure have a higher risk of torsades de pointes. In patients without a history of cardiac failure, continuing depression of the myocardium may lead to cardiac failure. SOLAVERT should not be used in patients with hypokalaemia or hypomagnesaemia prior to correction of imbalance; these conditions can exaggerate the degree of QT prolongation and increase the potential for torsades de pointes. Special attention should be given to electrolyte and acid–base balance in patients experiencing severe or prolonged diarrhoea or patients receiving concomitant magnesium- and/or potassium-depleting drugs. Care should be taken if beta-blockers have to be discontinued abruptly in patients with coronary artery disease. Hypersensitivity to catecholamines is observed in patients withdrawn from beta-blocker therapy. Severe exacerbation of angina pectoris and precipitation of myocardial infarction and ventricular arrhythmias have occurred following abrupt discontinuation of beta-blockade in patients with ischaemic heart disease.

Contraindications

SOLAVERT is contraindicated in patients with bronchospasm (such as bronchial asthma or chronic obstructive airway disease), allergic disorders (including allergic rhinitis) which may suggest a predisposition to bronchospasm, sinus bradycardia (less than 45–50 beats per minute), second and third degree AV block or sick sinus syndrome unless a functioning pacemaker is present, severe renal impairment (creatinine clearance less than 10 mL per minute), congenital or acquired long QT syndromes, and hypersensitivity to sotalol hydrochloride, other beta blockers, sulfonamides or the excipients. It is also contraindicated in patients with hypomagnesaemia, hypotension, and hypokalaemia.

PBS listing

SOLAVERT sotalol hydrochloride 80 mg tablet is listed on the PBS as a restricted item with an ex-manufacturer price of A$3.49.

Regulatory history

SOLAVERT sotalol hydrochloride 80 mg and 160 mg tablets were first registered on the ARTG on 22 August 2001.