Sotalol 80mg Tablets

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

Sotalol hydrochloride

Available from:

Milpharm Limited

ATC code:

C70AA07

INN (International Name):

Sotalol hydrochloride

Dosage:

80mg

Pharmaceutical form:

Tablets

Administration route:

Oral use

Units in package:

pack of 28 tablets

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Milpharm Limited

Therapeutic indications:

It is 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

Authorization status:

Authorised

Authorization date:

2003-07-21

Summary of Product characteristics

Sotalol 80mg Tablets
Summary of Product Characteristics Updated 28­Aug­2015 | Aurobindo Pharma ­ Milpharm Ltd.
1. Name of the medicinal product
Sotalol 80mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 80mg Sotalol hydrochloride
For excipients see 6.1
3. Pharmaceutical form
Tablet
Round, white to off­white, flat bevelled edged tablets with break line on one side.
4. Clinical particulars
4.1 Therapeutic indications
Sotalol 80mg Tablets are indicated for:
1. Ventricular arrhythmias:
• Treatment of life­threatening ventricular tachyarrhythmias;
• Treatment of symptomatic non­sustained ventricular tachyarrhythmias
2. Supraventricular arrhythmias:
• Prophylaxis of paroxysmal atrial tachycardia, paroxysmal atrial fibrillation, paroxysmal A­V nodal re­entrant
tachycardia, paroxysmal A­V re­entrant tachycardia using accessory pathways, and paroxysmal supraventricular
tachycardia after cardiac surgery;
• Maintenance of normal sinus rhythm following conversion of atrial fibrillation or atrial flutter
4.2 Posology and method of administration
Oral administration in adults:
As with other antiarrhythmic agents, it is recommended that Sotalol 80mg Tablets be initiated and doses increased in a
facility capable of monitoring and assessing cardiac rhythm. The dosage must be individualised 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 β­adrenergic blocking properties, treatment with Sotalol 80mg 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�