SOTACOR 80 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SOTALOL HYDROCHLORIDE

Available from:

Bristol-Myers Squibb (Holdings) Limited

ATC code:

C07AA07

INN (International Name):

SOTALOL HYDROCHLORIDE

Dosage:

80 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Beta blocking agents, non-selective

Authorization status:

Transfer Pending

Authorization date:

1983-07-05

Patient Information leaflet

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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sotacor 80 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg sotalol hydrochloride.
Excipients with known effect: Each tablet contains 53.8mg of lactose monohydrate.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Tablets
Round, biconvex white tablets with a break bar on each side.
The tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sotacor is indicated in adults for:
Ventricular arrhythmias:
-
Treatment of life-threatening ventricular tachyarrhythmias;
-
Treatment of symptomatic non-sustained ventricular tachyarrhythmias.
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 -adrenergic blocking properties, treatment with Sotacor�