CARDOL

What it is

CARDOL contains sotalol hydrochloride in tablet formulations 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 schedule is 160 mg daily, given in two divided doses at approximately 12 hour intervals. This dose may be increased, if necessary, after appropriate evaluation 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. CARDOL should be taken preferably 1–2 hours before meals, and 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.

Key safety warnings

The most dangerous adverse effect of antiarrhythmic drugs is the aggravation of preexisting arrhythmias or the provocation of new arrhythmias. The 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, high plasma drug concentrations, and with the concomitant use of sotalol and other medication 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%). In addition, in approximately 1% of patients, deaths were considered possibly drug-related. 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. CARDOL 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. Beta-blockers reduce placental perfusion, which may result in intrauterine fetal death, immature and premature deliveries and may cause bradycardia in the fetus and newborn infant. Sotalol is actively excreted in breast milk and therefore should not be administered to nursing mothers.

Contraindications

Bronchospasm (such as bronchial asthma or chronic obstructive airway disease). Sinus bradycardia (less than 45–50 beats per minute). Second and third degree atrioventricular block or sick sinus syndrome unless a functioning pacemaker is present. Uncontrolled congestive heart failure. Severe renal impairment (creatinine clearance less than 10 mL per minute). Congenital or acquired long QT syndromes. Hypomagnesaemia. Hypokalaemia.

PBS listing

CARDOL 160 mg tablet is listed on the PBS as one restricted item with an ex-manufacturer price of A$6.43.

Regulatory history

CARDOL sotalol hydrochloride 160 mg tablet was first listed on the ARTG on 4 February 1993.