SOTALOL Tablets Ref.[7103] Active ingredients: Sotalol

Posology

As with other antiarrhythmic agents, it is recommended that Sotalol 40mg Tablets 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 Sotalol 40mg Tablets 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 4.4 Warnings).

The initiation of treatment or changes in dosage with sotalol 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 4.4 Warnings and precautions).

Method of administration

The following dosing schedule can be recommended:

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

Oral dosage of sotalol 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 320 mg administered in two divided doses at approximately 12 hour intervals. Some patients with life-threatening refractory ventricular arrhythmias may require doses as high as 480-640 mg/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 4.4 Warnings).

Paediatric population

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

Dosage in renally impaired patients

Because sotalol 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:

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

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

Symptoms and treatment of overdose

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

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

Bradycardia: Atropine (0.5 to 2 mg 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

Shelf life: 36 months.

Do not store above 25°C. Store in original package.

The tablets are packed in 14-tablets blisters constituted from PVC/PVdC and aluminium foil.

Pack sizes: 28 and 56 tablets.

None.