sotalol hydrochloride: clinical use

Prescribing considerations

• Initiation and treatment changes require medical evaluation, including corrected QT measurement, renal function, electrolyte balance and concomitant medicines.
• Arrange an environment capable of rhythm monitoring when initiating or increasing treatment.
• Correct hypokalaemia or hypomagnesaemia before treatment and address prolonged diarrhoea or electrolyte-depleting therapy.
• Use particular caution with controlled left-ventricular dysfunction, recent myocardial infarction, diabetes, thyrotoxicosis, psoriasis and previous severe allergic reactions.
• Avoid abrupt withdrawal, particularly where ischaemic heart disease may be present.

Contraindications and cautions

• Sick sinus syndrome or symptomatic sinus bradycardia
• Second- or third-degree atrioventricular block without a functioning pacemaker
• Congenital or acquired long-QT syndrome or previous torsades de pointes
• Uncontrolled heart failure or cardiogenic shock
• Bronchial asthma or chronic obstructive airway disease
• Hypotension, except when caused by the arrhythmia
• Raynaud's phenomenon or severe peripheral circulatory disturbance
• Untreated phaeochromocytoma, metabolic acidosis or severe renal failure
• Hypersensitivity to sotalol, another beta blocker or an excipient
• Anaesthesia producing myocardial depression

Monitoring

• ECG rhythm and corrected QT interval, particularly during initiation and treatment changes
• Heart rate, blood pressure and symptoms of worsening heart failure or proarrhythmia
• Renal function because sotalol is predominantly eliminated unchanged in urine
• Serum potassium and magnesium, especially with diarrhoea or electrolyte-depleting medicines
• Glucose control and less obvious manifestations of hypoglycaemia in people with diabetes

Clinical pharmacology

Sotalol is a hydrophilic, non-selective beta-adrenoceptor antagonist with Vaughan Williams class II and III activity. It delays repolarisation and prolongs atrial, ventricular and accessory-pathway refractory periods. It is not metabolised, has negligible protein binding and is eliminated mainly unchanged through the kidneys.

Formulation and product differences

• The selected product is a round, white to off-white oral tablet with a break line.
• The SmPC describes the break line but does not state that it divides the tablet into equal portions.
• The selected formulation is described as essentially sodium-free.

Tablet

Route: Oral

Strengths: 40 mg, 80 mg