Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
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SOTACOR TABLETS 80 mg SOTACOR TABLETS 160 mg SOTACOR INJECTION 40 mg/4 mL SCHEDULING STATUS: S3 PROPRIETARY NAME (and dosage form): SOTACOR TABLETS 80 mg SOTACOR TABLETS 160 mg SOTACOR INJECTION 40 mg/4 mL COMPOSITION: SOTACOR tablets 80 mg contain 80 mg of sotalol hydrochloride SOTACOR tablets 160 mg contain 160 mg of sotalol hydrochloride SOTACOR injection: Sterile solution containing 10 mg sotalol hydrochloride per mL. SOTACOR (sotalol) is the hydrochloride of 4-(2-isopropylamino-1-hydroxyethyl)- methane sulphonanilide. PHARMACOLOGICAL CLASSIFICATION: A 5.2. Medicines affecting autonomic functions - adrenolytics (sympathicolytics). PHARMACOLOGICAL ACTION: SOTACOR (sotalol HCl) is a competitive nonselective beta-adrenergic receptor blocking agent, affecting both B 1 and B 2 receptors, devoid of intrinsic sympathomimetic activity (ISA) and membrane stabilizing activity (MSA). SOTACOR inhibits renin release. Its beta-adrenergic blocking activity causes a reduction in heart rate (negative chronotropic effect) and a limited reduction in the force of contraction (negative inotropic effect). These cardiac changes reduce myocardial oxygen consumption and cardiac work. SOTACOR has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. The Class II and III properties may be reflected on the surface electrocardiogram by a lengthening of the PR, QT and QTc (QT corrected for heart rate) intervals with no significant alteration in the QRS duration. The d- and l- isomers of sotalol HCl have similar Class III antiarrhythmic effects while the l -isomer is responsible for virtually all of the beta-blocking activity. Pharmacokinetics: After oral administration, peak levels are reached in 2.5 to 4 h Read the complete document