Sotalol

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Caution and personalized dose adjustment in patients with the following genotypes
  • Other genes that may be involved
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe

Austria: Sotacor, Sotahexal, Sotalol, Sotamed, Sotastad; Belgium: Sotalex, Sotalol; Bulgaria: Darob, Sotagamma, Sotahexal, Sotalex, Sotanorm; Czech Republic: Sotahexal, Sotalol; Denmark: Sotalol; Estonia: Sotahexal; Finland: Sotacor, Sotalin, Sotalol; France: Sotalex, Sotalol; Germany: Corsotalol, Darob, Favorex, Jutalex, Rentibloc, Sota-Puren, Sota-Saar, Sotabeta, Sotagamma, Sotahexal, Sotalex, Sotalodoc, Sotalol; Greece: Sotalol; Hungary: Sotahexal, Sotalex, Sotalol; Ireland: Sotacor, Sotoger; Italy: Rytmobeta, Sotalex, Sotalolo; Latvia: Sotogamma; Luxembourg: Sotalex; Malta: Sotalol; Netherlands: Sotacor, Sotalol; Poland: Biosotal, Darob, Gilucor, Sotahexal, Sotalex, Sotamerck; Portugal: Sotalol; Romania: Darob, Sotagamma, Sotalol; Slovakia: Sotalex; Spain: Sotalol, Sotapor; Sweden: Sotacor, Sotalol; UK: Beta-Cardone.

North America

Canada: Rylosol, Sotalol; USA: Betapace, Sorine, Sotalol.

Latin America

Argentina: Sotacor; Brazil: Sotacor, Sotahexal, Sotalol; Mexico: Sotaper.

Asia

Japan: Sotacor.

Drug combinations

Chemistry

Sotalol Hydrochloride: C~12~H~20~N~2~O~3~SHCl. Mw: 308.82. (1) Methanesulfonamide, N-[4-[1-hydroxy-2-[(1-methylethyl)amino]ethyl]phenyl]-, monohydrochloride; (2) 4′-[1-Hydroxy-2-(isopropylamino)ethyl]methanesulfonanilide monohydrochloride. CAS-959-24-0; CAS-3930-20-9 (sotalol)(1967).

Pharmacologic Category

Class III Antiarrhythmics. β-Adrenergic Blocking Agents. (ATC-Code: C07AA07).

Mechanism of action

Inhibits response to adrenergic stimuli by competitively blocking β~1~-adrenergic receptors within myocardium and β~2~-adrenergic receptors within bronchial and vascular smooth muscle. Exhibits antiarrhythmic activity characteristic of class II antiarrhythmic agents. Does not exhibit membrane-stabilizing activity, but exhibits electrophysiologic effects characteristic of class III antiarrhythmic agents (prolongs repolarization and refractoriness without affecting conduction). Does not exhibit intrinsic sympathomimetic activity. Selectively inhibits rapidly activating component of potassium channel involved in repolarization of cardiac cells in vitro. Does not appear to block sodium channels at usual doses (although it may at relatively high doses). Racemic mixture of 2 optical isomers which both exhibit class III antiarrhythmic activity, but only L-isomer exhibits β-blocking activity.

Therapeutic use

Ventricular arrhythmias. Atrial fibrillation and atrial flutter.

Pregnancy and lactiation implications

There are no adequate studies in pregnant women. Has been shown to cross placenta, and is found in amniotic fluid. Sotalol should be used during pregnancy only if potential benefit outweighs potential risk. Cases of neonatal hypoglycemia reported following maternal use of β-blockers at parturition or during breast-feeding. Enters breast milk (use caution).

Unlabeled use

Contraindications

Bronchial asthma. Sinus bradycardia (<50 bpm while awake). Sick sinus syndrome or second- or third-degree AV block unless functioning pacemaker is present. Congenital or acquired long QT interval syndromes. Baseline QT interval >450 ms. Cardiogenic shock. Uncontrolled heart failure. Hypokalemia (<4 mEq/L) in supraventricular arrhythmias (atrial fibrillation or flutter); do not use in hypokalemia or hypomagnesemia prior to correction of imbalance in ventricular arrhythmias. CrCl <40 mL/minute in supraventricular arrhythmias (atrial fibrillation or flutter). Known hypersensitivity to sotalol or any ingredient in the formulation.

Warnings and precautions

Use caution with history of severe anaphylaxis to allergens (patients taking β-blockers may become more sensitive to repeated challenges). Proarrhythmic effects might occur (QTc prolongation). Patients with bronchospastic disease should not receive β-blockers. Use with caution in diabetes mellitus (may potentiate hypoglycemia and/or mask signs and symptoms). Electrolyte imbalances should be corrected before initiating (especially hypokalemia and hypomagnesemia). Use with caution in compensated heart failure, in myasthenia gravis, within first 2 weeks post-myocardial infarct, and in peripheral vascular disease. In pheochromocytoma adequate α-blockade is required prior to use of any β-blocker. Use with caution in history of psychiatric illness (may cause or exacerbate CNS depression), in renal impairment, in patients receiving anesthetic agents which decrease myocardial function, and with calcium channel blockers (bradycardia or heart block can occur). Concurrent use with other QTc-prolonging drugs (including Class I and Class III antiarrhythmics) generally not recommended. β-Blocker therapy should not be withdrawn abruptly (particularly in coronary artery disease).

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