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Sotalol

Generic Name
Sotalol
Brand Names
Betapace, Sorine, Sotylize
Drug Type
Small Molecule
Chemical Formula
C12H20N2O3S
CAS Number
3930-20-9
Unique Ingredient Identifier
A6D97U294I

Overview

Sotalol is a methanesulfonanilide developed in 1960. It was the first of the class III anti arrhythmic drugs. Sotalol was first approved as an oral tablet on 30 October 1992. A racemic mixture of sotalol is currently formulated as a tablet, oral solution, and intravenous injection indicated for life threatening ventricular arrhythmias and maintaining normal sinus rhythm in atrial fibrillation or flutter.

Background

Sotalol is a methanesulfonanilide developed in 1960. It was the first of the class III anti arrhythmic drugs. Sotalol was first approved as an oral tablet on 30 October 1992. A racemic mixture of sotalol is currently formulated as a tablet, oral solution, and intravenous injection indicated for life threatening ventricular arrhythmias and maintaining normal sinus rhythm in atrial fibrillation or flutter.

Indication

Sotalol is indicated to treat life threatening ventricular arrhytmias and maintain normal sinus rhythm in patients with atrial fibrillation or flutter. There are also oral solutions and intravenous injections indicated for patients requiring sotalol, but for whom a tablet would not be appropriate.

Associated Conditions

  • Sinus Rhythm
  • Life-threatening ventricular arrhythmias

FDA Approved Products

Sotalol Hydrochloride
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:120 mg in 1 1
Approved: 2023/07/05
NDC:72162-2116
Sotalol Hydrochloride
Manufacturer:Apotex Corp.
Route:ORAL
Strength:80 mg in 1 1
Approved: 2023/07/05
NDC:60505-0080
Sotalol Hydrochloride
Manufacturer:Apotex Corp.
Route:ORAL
Strength:240 mg in 1 1
Approved: 2023/07/05
NDC:60505-0082
Sotalol Hydrochloride
Manufacturer:A-S Medication Solutions
Route:ORAL
Strength:80 mg in 1 1
Approved: 2023/07/05
NDC:50090-1299
Sotalol Hydrochloride
Manufacturer:PD-Rx Pharmaceuticals, Inc.
Route:ORAL
Strength:80 mg in 1 1
Approved: 2024/02/08
NDC:72789-137

Singapore Approved Products

SotaHexal 80mg Tablet
Manufacturer:Salutas Pharma GmbH
Form:TABLET, FILM COATED
Strength:80mg
Online:Yes
Approved: 2007/07/03
Approval:SIN13311P
APO-SOTALOL TABLET 160 mg
Manufacturer:APOTEX INC
Form:TABLET
Strength:160 mg
Online:Yes
Approved: 1997/01/13
Approval:SIN09139P

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