Țară: Irlanda
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Sursă: HPRA (Health Products Regulatory Authority)
SOTALOL HYDROCHLORIDE
Bristol-Myers Squibb (Holdings) Limited
C07AA07
SOTALOL HYDROCHLORIDE
80 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Beta blocking agents, non-selective
Transfer Pending
1983-07-05
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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 Citiți documentul complet