Sotalol

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.

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

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety Assessment for Sotalol Protocol in Outpatient Unit	2022/06/14	NCT05418036	Phase 4	UNKNOWN	University of Sao Paulo General Hospital
Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation	2022/03/15	NCT05279833	N/A	Completed	Sanofi
Prospective Evaluation Analysis and Kinetics Registry	2022/02/18	NCT05247320	N/A	Completed	University of Utah
Improvement in Endothelial Dysfunction After Initiation of Anti-arrhythmic Therapy in Atrial Fibrillation Patients	2019/10/16	NCT04128878	N/A	Completed	Samir Saba
Efficacy and Safety of Sotalol in Children With Arrhythmia	2019/03/29	NCT03895411	Phase 4	UNKNOWN	Shengjing Hospital
Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment	2019/02/19	NCT03845010	Not Applicable	Completed	Maatschap Cardiologie Zwolle
Bioequivalence Study of Sotalol, Tablets, 160 mg (Pharmtechnology LLC, Belarus), and Sotalex ®, Tablets, 160 mg (Bristol-Myers Squibb GmbH & Co. KGaA, Germany), in Healthy Volunteers Under Fasting Conditions	2019/01/10	NCT03799536	Phase 1	Completed	Pharmtechnology LLC
Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy (FAST RCT)	2015/12/08	NCT02624765	Phase 3	Completed	Edgar Jaeggi
Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation	2015/01/27	NCT02347111	Phase 4	Recruiting	University of Illinois at Chicago
Catheter Ablation Compared With Pharmacological Therapy for Atrial Fibrillation (CAPTAF Trial)	2014/11/19	NCT02294955	Not Applicable	UNKNOWN	Uppsala University Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Sotalol Hydrochloride	Carilion Materials Management	68151-2702	ORAL	80 mg in 1 1	2/22/2016
Sotalol Hydrochloride	Major Pharmaceuticals	0904-7143	ORAL	80 mg in 1 1	11/24/2021
sotalol hydrochloride	Physicians Total Care, Inc.	54868-5549	ORAL	160 mg in 1 1	4/23/2012
Sotalol Hydrochloride	Apotex Corp.	60505-0159	ORAL	120 mg in 1 1	7/5/2023
Sotalol Hydrochloride	PD-Rx Pharmaceuticals, Inc.	72789-138	ORAL	120 mg in 1 1	2/8/2024
Sotalol	Bayshore Pharmaceuticals LLC	76385-116	ORAL	160 mg in 1 1	12/6/2017
Sotalol Hydrochloride	Bryant Ranch Prepack	63629-2422	ORAL	80 mg in 1 1	2/2/2022
Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	0093-1062	ORAL	160 mg in 1 1	1/25/2023
Sotalol Hydrochloride	Proficient Rx LP	71205-046	ORAL	80 mg in 1 1	11/1/2022
Sotalol Hydrochloride	Proficient Rx LP	63187-426	ORAL	80 mg in 1 1	11/1/2019

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
SotaHexal 80mg Tablet	Salutas Pharma GmbH	SIN13311P	TABLET, FILM COATED	80mg	7/3/2007
APO-SOTALOL TABLET 160 mg	APOTEX INC	SIN09139P	TABLET	160 mg	1/13/1997

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Sotalol 80mg tablet bottle	133583	Alphapharm Pty Ltd	Medicine	A	12/11/2006
SOTACOR sotalol hydrochloride 80mg tablet blister pack	68964	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/16/1999
SOTALOL-STR sotalol hydrochloride 160 mg tablet blister pack	333530	Strides Pharma Science Pty Ltd	Medicine	A	5/4/2020
SOTALOL DAROB TABLETS 160 mg (BULK)	404971	Alphapharm Pty Ltd	Medicine	A	2/17/2023
SOTALOL-WGR sotalol hydrochloride 80 mg tablet blister pack	333533	GM Pharma International Pty Ltd	Medicine	A	5/4/2020
SOTACOR sotalol hydrochloride 160mg tablet blister pack	68966	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/16/1999
Sotalol hydrochloride 160 mg tablet (BULK)	392518	Alphapharm Pty Ltd	Medicine	A	7/20/2022
APX-SOTALOL sotalol hydrochloride 160 mg tablet blister pack	333532	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/4/2020
SOLAVERT sotalol hydrochloride 80mg tablet blister pack	79916	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/22/2001
SOTALOL SANDOZ Sotalol hydrochloride 160mg tablet blister pack	63724	Sandoz Pty Ltd	Medicine	A	4/2/1998

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MYLAN-SOTALOL	Mylan Pharmaceuticals ULC	02229779	Tablet - Oral	160 MG	10/21/1996
MYLAN-SOTALOL	Mylan Pharmaceuticals ULC	02229778	Tablet - Oral	80 MG	10/21/1996
LINSOTALOL -TAB 160MG	linson pharma co.	02170841	Tablet - Oral	160 MG	12/31/1995
LINSOTALOL - TAB 80MG	linson pharma co.	02170833	Tablet - Oral	80 MG	12/31/1995
APO-SOTALOL	Apotex Inc	02167794	Tablet - Oral	160 MG	12/31/1995
SOTACOR TAB 80MG	bristol labs division of bristol-myers squibb	00897272	Tablet - Oral	80 MG	12/31/1993
SANDOZ SOTALOL	Sandoz Canada, Inc.	02257831	Tablet - Oral	80 MG	9/21/2004
RHOXAL-SOTALOL	rhoxalpharma inc	02234008	Tablet - Oral	80 MG	12/2/1997
NOVO-SOTALOL TAB 80MG	novopharm limited	02231181	Tablet - Oral	80 MG	5/13/1997
RIVA-SOTALOL	laboratoire riva inc.	02272164	Tablet - Oral	80 MG	6/4/2010

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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