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Sotalol
Betapace, Sotylize (sotalol) is a small molecule pharmaceutical. Sotalol was first approved as Betapace on 1992-10-30. It is used to treat atrial fibrillation, atrial flutter, cardiac arrhythmias, supraventricular tachycardia, and ventricular fibrillation amongst others in the USA. The pharmaceutical is active against beta-1 adrenergic receptor and beta-2 adrenergic receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Betapace, Sotylize (generic drugs available since 2000-05-01)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sotalol hydrochloride
Tradename
Company
Number
Date
Products
SOTALOL HYDROCHLORIDEAltaThera PharmaceuticalsN-022306 RX2009-07-02
1 products, RLD, RS
SOTYLIZEAzurityN-205108 RX2014-10-22
1 products, RLD, RS
BETAPACELEGACY PHARMAN-019865 RX1992-10-30
4 products, RLD
BETAPACE AFLEGACY PHARMAN-021151 RX2000-02-22
3 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
betapace betapace afNew Drug Application2018-08-10
sorineANDA2021-04-26
sotalol hydrochlorideNew Drug Application2023-05-27
sotylizeNew Drug Application2018-12-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
atrial fibrillationEFO_0000275D001281I48.0
atrial flutterEFO_0003911D001282—
cardiac arrhythmiasEFO_0004269D001145I49.9
supraventricular tachycardiaHP_0004755D013617I47.1
ventricular fibrillationEFO_0004287D014693I49.01
ventricular tachycardia—D017180I47.2
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Sotalol Hydrochloride, Sotalol Hydrochloride, Altathera Pharms Llc
115832162039-08-21U-3549
107991382039-04-05U-3125, U-3549
105126202038-08-18U-2769, U-3547
Sotalol Hydrochloride, Sotylize, Azurity
97242972035-08-31DPU-2096
102068952034-04-01DPU-2096, U-2494
110137032034-04-01DP
ATC Codes
C: Cardiovascular system drugs
— C07: Beta-adrenergic blocking agents
— C07A: Beta blocking agents
— C07AA: Beta blocking agents, non-selective
— C07AA07: Sotalol
— C07B: Beta blocking agents and thiazides
— C07BA: Beta blocking agents, non-selective, and thiazides
— C07BA07: Sotalol and thiazides
— C07F: Beta blocking agents, other combinations
— C07FX: Beta blocking agents, other combinations
— C07FX02: Sotalol and acetylsalicylic acid
HCPCS
Code
Description
C9482
Injection, sotalol hydrochloride, 1 mg
Clinical
Clinical Trials
21 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Dental cariesD003731EFO_0003819K02—111—2
ConstipationD003248HP_0002019K59.0——11—2
InfectionsD007239EFO_0000544———1—1
Communicable diseasesD003141———1—1
IleusD045823K56.7———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382U07.1—11——1
Charcot-marie-tooth diseaseD002607G60.0——1——1
Knee osteoarthritisD020370EFO_0004616M17—11——1
GaitD005684—11——1
InjectionsD007267—11——1
HyperkalemiaD006947HP_0002153E87.5——1——1
Cumulative trauma disordersD012090—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.81—1———1
Parkinson diseaseD010300EFO_0002508G20—1———1
Alzheimer diseaseD000544EFO_0000249F03—1———1
Acute painD059787R5211———1
Bacterial infectionsD001424A4911———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1———12
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MicrobiotaD064307————11
SmokingD012907EFO_0003768F17————11
Blood coagulation disordersD001778EFO_0009314D68.9————11
Liver diseasesD008107EFO_0001421K70-K77————11
MetabolismD008660GO_0008152————11
PharmacokineticsD010599————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSOTALOL
INNsotalol
Description
Sotalol is a sulfonamide that is N-phenylmethanesulfonamide in which the phenyl group is substituted at position 4 by a 1-hydroxy-2-(isopropylamino)ethyl group. It has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. It is used (usually as the hydrochloride salt) for the management of ventricular and supraventricular arrhythmias. It has a role as a beta-adrenergic antagonist, an anti-arrhythmia drug, an environmental contaminant and a xenobiotic. It is a member of ethanolamines, a secondary amino compound, a secondary alcohol and a sulfonamide. It is a conjugate base of a sotalol(1+).
Classification
Small molecule
Drug classcombined alpha and beta blockers
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(C)NCC(O)c1ccc(NS(C)(=O)=O)cc1
Identifiers
PDB—
CAS-ID3930-20-9
RxCUI9947
ChEMBL IDCHEMBL471
ChEBI ID63622
PubChem CID5253
DrugBankDB00489
UNII IDA6D97U294I (ChemIDplus, GSRS)
Target
Agency Approved
ADRB1
ADRB1
ADRB2
ADRB2
Organism
Homo sapiens
Gene name
ADRB1
Gene synonyms
ADRB1R, B1AR
NCBI Gene ID
153
Protein name
beta-1 adrenergic receptor
Protein synonyms
adrenergic, beta-1-, receptor, Beta-1 adrenoceptor, Beta-1 adrenoreceptor
Uniprot ID
P08588
Mouse ortholog
Adrb1 (11554)
beta-1 adrenergic receptor (P34971)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 6,281 documents
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Safety
Black-box Warning
Black-box warning for: Betapace betapace af, Sorine, Sotalol hydrochloride, Sotylize
Adverse Events
Top Adverse Reactions
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166 adverse events reported
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