SOTACOR Tablet Ref.[27749] Active ingredients: Sotalol

Posology

Paediatric population

There is no relevant use of Sotacor in the paediatric population.

The initiation of treatment or changes in dosage with Sotacor should follow an appropriate medical evaluation including ECG control with measurement of the corrected QT interval, and assessment of renal function, electrolyte balance, and concomitant medications (see section 4.4).

As with other antiarrhythmic agents, it is recommended that Sotacor be initiated and doses increased in a facility capable of monitoring and assessing cardiac rhythm. The dosage must be individualized and based on the patient’s response. Proarrhythmic events can occur not only at initiation of therapy, but also with each upward dosage adjustment.

In view of its β-adrenergic blocking properties, treatment with Sotacor should not be discontinued suddenly, especially in patients with ischaemic heart disease (angina pectoris, prior acute myocardial infarction) or hypertension, to prevent exacerbation of the disease (see section 4.4).

Method of administration

The following dosing schedule can be recommended:

The initial dose is 80mg, administered either singly or as two divided doses.

Oral dosage of Sotacor should be adjusted gradually allowing 2-3 days between dosing increments in order to attain steady-state, and to allow monitoring of QT intervals. Most patients respond to a daily dose of 160 to 320mg administered in two divided doses at approximately 12 hour intervals. Some patients with life-threatening refractory ventricular arrhythmias may require doses as high as 480 – 640mg/day. These doses should be used under specialist supervision and should only be prescribed when the potential benefit outweighs the increased risk of adverse events, particularly proarrhythmias (see section 4.4).

Dosage in renally impaired patients

Because Sotacor is excreted mainly in urine, the dosage should be reduced when the creatinine clearance is less than 60 ml/min according to the following table:

Creatinine clearance (ml/min):

The creatinine clearance can be estimated from serum creatinine by the Cockroft and Gault formula:

Men = (140 – age) x weight (kg) / 72 x serum creatinine (mg/dl)

Women: idem x 0.85

When serum creatinine is given in µmol/l, divide the value by 88.4 (1mg/dl = 88.4 µmol/l).

Dosage in hepatically impaired patients

Since Sotacor is not subject to first-pass metabolism, patients with hepatic impairment show no alteration in clearance of Sotacor. No dosage adjustment is required in hepatically impaired patients.

Intentional or accidental overdosage with Sotacor has rarely resulted in death. Haemodialysis results in a large reduction of plasma levels of sotalol.

Symptoms and treatment of overdosage: The most common signs to be expected are bradycardia, congestive heart failure, hypotension, bronchospasm and hypoglycaemia. In cases of massive intentional overdosage (2-16 g) of Sotacor the following clinical findings were seen: hypotension, bradycardia, prolongation of QT-interval, premature ventricular complexes, ventricular tachycardia, torsades de pointes.

If overdosage occurs, therapy with Sotacor should be discontinued and the patient observed closely. In addition, if required, the following therapeutic measures are suggested:

Bradycardia: Atropine (0.5 to 2mg IV), another anticholinergic drug, a beta-adrenergic agonist (isoprenaline, 5 microgram per minute, up to 25 microgram, by slow IV injection) or transvenous cardiac pacing.

Heart Block (second and third degree): Transvenous cardiac pacing.

Hypotension: Adrenaline rather than isoprenaline or noradrenaline may be useful, depending on associated factors.

Bronchospasm: Aminophylline or aerosol beta-2-receptor stimulant.

Torsades de pointes: DC cardioversion, transvenous cardiac pacing, adrenaline, and/or magnesium sulphate.

3 years.

Do not store above 25°C. Store in the original package to protect from light.

Original packs of 28 or 30 tablets: blister strips of 2x 14 tablets or 3x 10 tablets, respectively, to a carton.

No special requirements.