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Sotalol 80mg (pack of 28) POM

Item no: SOTALOL8
Sotalol 80mg Tablets are indicated for the treatment of life-threatening ventricular tachyarrhythmias and symptomatic non-sustained ventricular tachyarrhythmias.
Prescription Medicine
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Sotalol 80mg.

Therapeutic indications
Sotalol 80mg Tablets are indicated for:
1. Ventricular arrhythmias:
• Treatment of life-threatening ventricular tachyarrhythmias;
• Treatment of symptomatic non-sustained ventricular tachyarrhythmias

2. Supraventricular arrhythmias:
• Prophylaxis of paroxysmal atrial tachycardia, paroxysmal atrial fibrillation, paroxysmal A-V nodal re-entrant tachycardia, paroxysmal A-V re-entrant tachycardia using accessory pathways, and paroxysmal supraventricular tachycardia after cardiac surgery;
• Maintenance of normal sinus rhythm following conversion of atrial fibrillation or atrial flutter

Posology and method of administration

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 ß-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.

For full data sheet go to: https://www.medicines.org.uk/emc/product/7038/smpc

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