sotalol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
aromatic ring -CH(-OH)-CH2-NH-R	2464	3930-20-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: sotalol DL-Sotalol sotalol hydrochloride sotylize sotalol HCl	An adrenergic beta-antagonist that is used in the treatment of life-threatening arrhythmias. Molecular weight: 272.36 Formula: C12H20N2O3S CLOGP: 0.23 LIPINSKI: 0 HAC: 5 HDO: 3 TPSA: 78.43 ALOGS: -2.54 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

sotalol
DL-Sotalol
sotalol hydrochloride
sotylize
sotalol HCl

An adrenergic beta-antagonist that is used in the treatment of life-threatening arrhythmias.

Molecular weight: 272.36
Formula: C12H20N2O3S
CLOGP: 0.23
LIPINSKI: 0
HAC: 5
HDO: 3
TPSA: 78.43
ALOGS: -2.54
ROTB: 5

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.16	g	O
0.16	g	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	137 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	85 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	19.57 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	95 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	1.30 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.62 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	6.30 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Oct. 30, 1992	FDA	COVIS PHARMA SARL

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Atrial fibrillation	351.03	14.55	247	12372	108650	56170798
Torsade de pointes	275.55	14.55	104	12515	12336	56267112
Electrocardiogram QT prolonged	187.62	14.55	129	12490	54459	56224989
Bradycardia	115.80	14.55	106	12513	67398	56212050
Drug interaction	101.34	14.55	174	12445	209581	56069867
International normalised ratio increased	87.12	14.55	75	12544	43966	56235482
Arrhythmia	86.69	14.55	68	12551	35015	56244433
Ventricular tachycardia	75.22	14.55	47	12572	16854	56262594
Hyponatraemia	70.55	14.55	100	12519	102039	56177409
Hypotension	58.92	14.55	155	12464	250353	56029095
Atrial tachycardia	54.20	14.55	20	12599	2221	56277227
Urinary incontinence	53.71	14.55	48	12571	29537	56249911
Hyperkalaemia	51.13	14.55	60	12559	50805	56228643
Ischaemic stroke	46.75	14.55	35	12584	16807	56262641
Rheumatoid arthritis	46.60	14.55	14	12605	382590	55896858
Atrial flutter	44.62	14.55	27	12592	9142	56270306
Sinus bradycardia	44.01	14.55	31	12588	13555	56265893
Cardiac arrest	43.39	14.55	73	12546	86241	56193207
Erythromelalgia	42.49	14.55	9	12610	123	56279325
Hepatocellular injury	40.36	14.55	39	12580	26475	56252973
Cardio-respiratory arrest	39.40	14.55	55	12564	55266	56224182
Syncope	38.66	14.55	79	12540	108120	56171328
Asthenia	38.20	14.55	165	12454	342808	55936640
Atrioventricular block	38.01	14.55	22	12597	6865	56272583
Cardiac disorder	37.83	14.55	49	12570	45838	56233610
Palpitations	37.07	14.55	74	12545	99598	56179850
Cerebral haematoma	36.93	14.55	17	12602	3306	56276142
Inappropriate antidiuretic hormone secretion	34.69	14.55	27	12592	13729	56265719
Apallic syndrome	32.47	14.55	10	12609	638	56278810
Presyncope	32.28	14.55	34	12585	25548	56253900
Bundle branch block left	31.64	14.55	19	12600	6343	56273105
Localised oedema	30.33	14.55	17	12602	4992	56274456
Ventricular arrhythmia	30.24	14.55	15	12604	3439	56276009
Acute kidney injury	29.23	14.55	119	12500	240644	56038804
Long QT syndrome	28.85	14.55	14	12605	3062	56276386
Ventricular fibrillation	28.71	14.55	22	12597	10930	56268518
Pain	27.74	14.55	68	12551	663116	55616332
Subdural haematoma	26.69	14.55	23	12596	13476	56265972
Gastrointestinal haemorrhage	26.58	14.55	55	12564	75896	56203552
Melaena	26.16	14.55	32	12587	28258	56251190
Joint swelling	25.27	14.55	17	12602	289783	55989665
Systemic lupus erythematosus	24.98	14.55	5	12614	180073	56099375
Malaise	24.86	14.55	154	12465	367706	55911742
Organising pneumonia	24.14	14.55	15	12604	5320	56274128
Sinus node dysfunction	24.03	14.55	14	12605	4420	56275028
Drug intolerance	23.81	14.55	15	12604	264803	56014645
Nasal mucosal erosion	23.56	14.55	5	12614	69	56279379
Haematoma	23.03	14.55	32	12587	31987	56247461
Cardiac failure congestive	22.32	14.55	56	12563	87664	56191784
Contraindicated product administered	22.31	14.55	7	12612	186279	56093169
Cardiac ablation	21.73	14.55	9	12610	1358	56278090
Electrocardiogram QRS complex prolonged	21.33	14.55	14	12605	5453	56273995
Wound	21.13	14.55	3	12616	138801	56140647
Hypoglycaemia	20.21	14.55	41	12578	55774	56223674
Loss of consciousness	20.10	14.55	62	12557	109287	56170161
Anaemia macrocytic	20.07	14.55	11	12608	3092	56276356
Arthropathy	19.93	14.55	10	12609	200265	56079183
Noninfective gingivitis	18.42	14.55	8	12611	1356	56278092
Occupational exposure to product	18.32	14.55	9	12610	2021	56277427
Hypersensitivity	17.51	14.55	19	12600	256389	56023059
Fall	17.27	14.55	138	12481	357372	55922076
Infusion related reaction	17.22	14.55	13	12606	208918	56070530
Arthralgia	16.85	14.55	57	12562	501612	55777836
Haemorrhagic stroke	16.74	14.55	12	12607	5391	56274057
Abdominal discomfort	16.35	14.55	23	12596	277251	56002197
Transient ischaemic attack	16.33	14.55	28	12591	33549	56245899
Skin test positive	16.24	14.55	6	12613	668	56278780
Cerebral congestion	16.24	14.55	3	12616	19	56279429
Blood loss anaemia	16.13	14.55	14	12605	8283	56271165
Optic nerve infarction	15.98	14.55	3	12616	21	56279427
Subarachnoid haemorrhage	15.98	14.55	16	12603	11331	56268117
Infection	15.81	14.55	13	12606	200193	56079255
Resting tremor	15.81	14.55	6	12613	720	56278728
Blood pressure increased	15.45	14.55	69	12550	145107	56134341
Cerebrovascular accident	15.28	14.55	53	12566	99217	56180231
Cardioactive drug level increased	15.25	14.55	8	12611	2061	56277387
Endodontic procedure	15.20	14.55	9	12610	2927	56276521
Acute pulmonary oedema	15.13	14.55	13	12606	7584	56271864
Muscle haemorrhage	15.09	14.55	9	12610	2966	56276482
Electrocardiogram T wave amplitude increased	14.85	14.55	3	12616	32	56279416
Livedo reticularis	14.67	14.55	8	12611	2227	56277221

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Atrial fibrillation	249.83	13.87	259	11786	113524	31571775
Ventricular tachycardia	140.50	13.87	96	11949	23605	31661694
Bradycardia	125.81	13.87	143	11902	69184	31616115
Electrocardiogram QT prolonged	98.71	13.87	95	11950	37892	31647407
Torsade de pointes	88.79	13.87	46	11999	6804	31678495
Atrial flutter	63.20	13.87	49	11996	14606	31670693
Palpitations	55.40	13.87	67	11978	34516	31650783
Cardiogenic shock	54.35	13.87	54	11991	22354	31662945
Arrhythmia	48.02	13.87	61	11984	33016	31652283
Drug interaction	44.07	13.87	176	11869	208367	31476932
Apallic syndrome	41.20	13.87	11	12034	243	31685056
Hypotension	40.31	13.87	169	11876	204449	31480850
Atrial thrombosis	39.26	13.87	18	12027	2039	31683260
Antiacetylcholine receptor antibody positive	38.65	13.87	8	12037	54	31685245
Pacemaker generated rhythm	37.68	13.87	8	12037	62	31685237
Ventricular arrhythmia	36.74	13.87	23	12022	4868	31680431
Staring	35.61	13.87	15	12030	1387	31683912
Cardiac ablation	33.63	13.87	13	12032	962	31684337
International normalised ratio increased	33.54	13.87	61	11984	45162	31640137
Daydreaming	33.48	13.87	11	12034	506	31684793
Haemoptysis	32.69	13.87	50	11995	32139	31653160
Ischaemic stroke	32.39	13.87	36	12009	16935	31668364
Pallor	31.98	13.87	41	12004	22383	31662916
Petit mal epilepsy	30.63	13.87	17	12028	2883	31682416
Incontinence	27.65	13.87	20	12025	5366	31679933
Loss of consciousness	27.61	13.87	78	11967	77277	31608022
Dissociation	26.68	13.87	12	12033	1300	31683999
BRASH syndrome	25.57	13.87	8	12037	314	31684985
Long QT syndrome	25.40	13.87	14	12031	2342	31682957
Presyncope	23.64	13.87	31	12014	17297	31668002
Xanthopsia	21.92	13.87	6	12039	146	31685153
Drug abuse	20.90	13.87	4	12041	87754	31597545
Rectal haemorrhage	20.87	13.87	44	12001	36260	31649039
Cardiac disorder	20.79	13.87	46	11999	39168	31646131
Heart rate abnormal	20.61	13.87	11	12034	1727	31683572
Brugada syndrome	19.30	13.87	8	12037	710	31684589
Grandiosity	17.44	13.87	6	12039	318	31684981
Acquired haemophilia	17.06	13.87	8	12037	953	31684346
Cardiac failure	16.85	13.87	71	11974	85882	31599417
Cardiac failure congestive	16.69	13.87	67	11978	79320	31605979
Pyrexia	16.31	13.87	60	11985	303780	31381519
Haematuria	15.83	13.87	46	11999	46268	31639031
Pressure of speech	15.27	13.87	6	12039	464	31684835
Dyspnoea	14.81	13.87	197	11848	343282	31342017
Food interaction	14.42	13.87	7	12038	900	31684399
Gingival bleeding	14.34	13.87	15	12030	6586	31678713
Venous pressure increased	14.28	13.87	3	12042	22	31685277
Tachycardia induced cardiomyopathy	14.11	13.87	4	12041	111	31685188

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Atrial fibrillation	478.75	13.39	417	21160	183931	70722936
Torsade de pointes	348.27	13.39	149	21428	17967	70888900
Electrocardiogram QT prolonged	263.99	13.39	212	21365	83305	70823562
Bradycardia	227.07	13.39	232	21345	124383	70782484
Ventricular tachycardia	208.96	13.39	133	21444	36290	70870577
Drug interaction	132.02	13.39	330	21247	381111	70525756
Arrhythmia	106.61	13.39	107	21470	56036	70850831
Atrial flutter	103.72	13.39	69	21508	20258	70886609
International normalised ratio increased	103.20	13.39	125	21452	80601	70826266
Hypotension	82.36	13.39	290	21287	404091	70502776
Ischaemic stroke	80.19	13.39	70	21507	30750	70876117
Palpitations	78.09	13.39	129	21448	110624	70796243
Cardiogenic shock	68.54	13.39	69	21508	36238	70870629
Apallic syndrome	66.48	13.39	20	21557	863	70906004
Ventricular arrhythmia	64.17	13.39	36	21541	7794	70899073
Long QT syndrome	53.42	13.39	28	21549	5299	70901568
Atrial thrombosis	50.55	13.39	23	21554	3202	70903665
Loss of consciousness	47.76	13.39	129	21448	155587	70751280
Syncope	46.60	13.39	133	21444	165576	70741291
Rheumatoid arthritis	43.79	13.39	17	21560	291788	70615079
Cardiac arrest	40.84	13.39	124	21453	159710	70747157
Cardiac ablation	39.92	13.39	17	21560	2021	70904846
Antiacetylcholine receptor antibody positive	39.57	13.39	8	21569	61	70906806
Pacemaker generated rhythm	39.12	13.39	8	21569	65	70906802
Rectal haemorrhage	38.95	13.39	71	21506	65760	70841107
Inappropriate antidiuretic hormone secretion	38.11	13.39	41	21536	23235	70883632
Cardiac disorder	37.61	13.39	66	21511	59349	70847518
Erythromelalgia	36.31	13.39	9	21568	185	70906682
Ventricular fibrillation	36.28	13.39	43	21534	27068	70879799
Sinus bradycardia	35.88	13.39	40	21537	23583	70883284
Acute kidney injury	35.87	13.39	257	21320	474367	70432500
Atrial tachycardia	35.73	13.39	19	21558	3701	70903166
Presyncope	35.39	13.39	50	21527	37388	70869479
Cerebral haematoma	35.13	13.39	24	21553	7354	70899513
Haemoptysis	34.99	13.39	59	21518	51393	70855474
Sinus node dysfunction	33.37	13.39	23	21554	7146	70899721
Asthenia	32.38	13.39	244	21333	457422	70449445
Haemorrhagic stroke	32.29	13.39	26	21551	10216	70896651
Urinary incontinence	32.08	13.39	48	21529	37794	70869073
Cardiac failure congestive	31.74	13.39	102	21475	135355	70771512
Hyponatraemia	30.91	13.39	113	21464	159974	70746893
Staring	30.75	13.39	15	21562	2441	70904426
Daydreaming	30.57	13.39	11	21566	835	70906032
Joint swelling	30.14	13.39	20	21557	253191	70653676
Pain	28.63	13.39	97	21480	628719	70278148
Arthralgia	28.50	13.39	70	21507	503320	70403547
Subdural haematoma	27.50	13.39	39	21538	29259	70877608
Gastrointestinal haemorrhage	27.38	13.39	98	21479	137310	70769557
BRASH syndrome	25.74	13.39	9	21568	628	70906239
Cardio-respiratory arrest	24.67	13.39	77	21500	100600	70806267
Haematoma	24.65	13.39	49	21528	48369	70858498
Petit mal epilepsy	24.25	13.39	17	21560	5427	70901440
Occupational exposure to product	24.25	13.39	9	21568	746	70906121
Melaena	23.99	13.39	53	21524	56302	70850565
Pallor	23.99	13.39	44	21533	40930	70865937
Hyperkalaemia	23.83	13.39	79	21498	106512	70800355
Organising pneumonia	22.53	13.39	21	21556	10029	70896838
Nasal mucosal erosion	22.04	13.39	5	21572	69	70906798
Dissociation	21.03	13.39	13	21564	3363	70903504
Transient ischaemic attack	20.46	13.39	44	21533	45900	70860967
Hepatocellular injury	20.36	13.39	44	21533	46047	70860820
Cardiac failure	20.28	13.39	92	21485	143449	70763418
Fall	20.14	13.39	215	21362	443881	70462986
Cerebrovascular accident	19.56	13.39	91	21486	143379	70763488
Blood loss anaemia	19.48	13.39	23	21554	14418	70892449
Malaise	19.36	13.39	209	21368	432723	70474144
Medication error	19.31	13.39	49	21528	56863	70850004
Acute pulmonary oedema	19.16	13.39	22	21555	13390	70893477
Left ventricular failure	19.11	13.39	18	21559	8710	70898157
Xanthopsia	18.88	13.39	6	21571	311	70906556
Atrioventricular block	18.44	13.39	21	21556	12667	70894200
Incontinence	17.99	13.39	21	21556	13007	70893860
Hypoglycaemia	17.69	13.39	66	21511	94298	70812569
Brugada syndrome	17.57	13.39	8	21569	1115	70905752
Systemic lupus erythematosus	16.89	13.39	5	21572	101897	70804970
Shock haemorrhagic	16.84	13.39	24	21553	18082	70888785
Endodontic procedure	16.39	13.39	10	21567	2527	70904340
Arthropathy	16.35	13.39	13	21564	150044	70756823
Hyperthyroidism	16.34	13.39	25	21552	20066	70886801
Haemorrhage intracranial	16.29	13.39	28	21549	24749	70882118
Alopecia	16.20	13.39	22	21555	198468	70708399
Cardioversion	16.05	13.39	9	21568	1945	70904922
Junctional ectopic tachycardia	15.92	13.39	3	21574	15	70906852
Haematuria	15.91	13.39	49	21528	63524	70843343
Localised oedema	15.67	13.39	15	21562	7406	70899461
Infection	15.61	13.39	25	21552	210760	70696107
Dizziness	15.48	13.39	212	21365	463929	70442938
Mobility decreased	15.43	13.39	6	21571	102993	70803874
Grandiosity	15.34	13.39	6	21571	574	70906293
Asthma	15.10	13.39	9	21568	120784	70786083
Pressure of speech	15.03	13.39	7	21570	1028	70905839
Noninfective gingivitis	15.02	13.39	8	21569	1563	70905304
Musculoskeletal stiffness	14.64	13.39	14	21563	147746	70759121
Tachycardia	14.41	13.39	90	21487	158456	70748411
Venous pressure increased	14.20	13.39	3	21574	29	70906838
Acquired haemophilia	13.77	13.39	8	21569	1849	70905018
Prothrombin time ratio decreased	13.54	13.39	6	21571	785	70906082
Intraventricular haemorrhage	13.51	13.39	11	21566	4390	70902477

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C07AA07	CARDIOVASCULAR SYSTEM BETA BLOCKING AGENTS BETA BLOCKING AGENTS Beta blocking agents, non-selective
ATC	C07BA07	CARDIOVASCULAR SYSTEM BETA BLOCKING AGENTS BETA BLOCKING AGENTS AND THIAZIDES Beta blocking agents, non-selective, and thiazides
ATC	C07FX02	CARDIOVASCULAR SYSTEM BETA BLOCKING AGENTS BETA BLOCKING AGENTS, OTHER COMBINATIONS Beta blocking agents, other combinations
FDA MoA	N0000000161	Adrenergic beta-Antagonists
FDA PE	N0000008330	Cardiac Rhythm Alteration
FDA EPC	N0000175426	Antiarrhythmic
MeSH PA	D018663	Adrenergic Agents
MeSH PA	D018674	Adrenergic Antagonists
MeSH PA	D000319	Adrenergic beta-Antagonists
MeSH PA	D000889	Anti-Arrhythmia Agents
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D013565	Sympatholytics
CHEBI has role	CHEBI:35530	beta-adrenergic blockers
CHEBI has role	CHEBI:38070	antiarrhythmic agent
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:78298	environmental contaminants

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Atrial fibrillation	indication	49436004	DOID:0060224
Life-Threatening Ventricular Tachycardia	indication
Bronchospasm	contraindication	4386001
Complete atrioventricular block	contraindication	27885002
Torsades de pointes	contraindication	31722008
Sick sinus syndrome	contraindication	36083008	DOID:13884
Anaphylaxis	contraindication	39579001
Hypokalemia	contraindication	43339004
Low blood pressure	contraindication	45007003
Sinus bradycardia	contraindication	49710005
Diabetes mellitus	contraindication	73211009	DOID:9351
Cardiogenic shock	contraindication	89138009
Prolonged QT interval	contraindication	111975006
Hypomagnesemia	contraindication	190855004
Second degree atrioventricular block	contraindication	195042002
Decompensated cardiac failure	contraindication	195111005
Asthma	contraindication	195967001	DOID:2841
Impaired renal function disorder	contraindication	197663003
Pregnancy, function	contraindication	289908002
Congenital long QT syndrome	contraindication	442917000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.95	acidic
pKa2	9.22	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
5MG/ML (5MG/ML)	SOTYLIZE	AZURITY	N205108	Oct. 22, 2014	RX	SOLUTION	ORAL	10206895	April 1, 2034	INDICATED FOR THE TREATMENT OF VENTRICULAR ARRHYTHMIAS, SUCH AS SUSTAINED VENTRICULAR TACHYCARDIA, THAT IN THE JUDGEMENT OF THE PHYSICIAN ARE LIFE-THREATENING
5MG/ML (5MG/ML)	SOTYLIZE	AZURITY	N205108	Oct. 22, 2014	RX	SOLUTION	ORAL	10206895	April 1, 2034	SOTYLIZE IS INDICATED FOR THE MAINTENANCE OF NORMAL SINUS RHYTHM [DELAY IN TIME TO RECURRENCE OF ATRIAL FIBRILLATION/ATRIAL FLUTTER (AFIB/AFL)] IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM
5MG/ML (5MG/ML)	SOTYLIZE	AZURITY	N205108	Oct. 22, 2014	RX	SOLUTION	ORAL	9724297	Aug. 31, 2035	SOTYLIZE IS INDICATED FOR THE MAINTENANCE OF NORMAL SINUS RHYTHM [DELAY IN TIME TO RECURRENCE OF ATRIAL FIBRILLATION/ATRIAL FLUTTER (AFIB/AFL)] IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM
150MG/10ML (15MG/ML)	SOTALOL HYDROCHLORIDE	ALTATHERA PHARMS LLC	N022306	July 2, 2009	RX	SOLUTION	INTRAVENOUS	10512620	Aug. 18, 2038	DOSING REGIMEN FOR INTRAVENOUS SOTALOL FOR ADMINISTRATION IN A FACILITY THAT CAN PROVIDE CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING AND CARDIAC RESUSCITATION.
150MG/10ML (15MG/ML)	SOTALOL HYDROCHLORIDE	ALTATHERA PHARMS LLC	N022306	July 2, 2009	RX	SOLUTION	INTRAVENOUS	10799138	April 5, 2039	USE FOR LOADING DOSE IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM OR FOR THE TREATMENT OF LIFE-THREATENING VENTRICULAR TACHYCARDIA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Beta-1 adrenergic receptor	GPCR	P08588	ADRB1_HUMAN	ANTAGONIST	Ki	6.10	WOMBAT-PK	CHEMBL
Beta-2 adrenergic receptor	GPCR	P07550	ADRB2_HUMAN	ANTAGONIST	Ki	6.90	WOMBAT-PK	CHEMBL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN	BLOCKER	Ki	4	WOMBAT-PK	CHEMBL
Beta-2 adrenergic receptor	GPCR		ADRB2_BOVIN		Kd	6.24	CHEMBL
Beta-2 adrenergic receptor	GPCR		ADRB2_CANFA		IC50	5.30	CHEMBL

External reference:

ID	Source
4020814	VUID
N0000148334	NUI
D01026	KEGG_DRUG
959-24-0	SECONDARY_CAS_RN
4020779	VANDF
4020814	VANDF
C0037707	UMLSCUI
CHEBI:63622	CHEBI
CHEMBL471	ChEMBL_ID
DB00489	DRUGBANK_ID
CHEMBL1700	ChEMBL_ID
D013015	MESH_DESCRIPTOR_UI
5253	PUBCHEM_CID
7297	IUPHAR_LIGAND_ID
2350	INN_ID
A6D97U294I	UNII
1593726	RXNORM
230116	MMSL
31427	MMSL
5503	MMSL
d00371	MMSL
003453	NDDF
004111	NDDF
125691000	SNOMEDCT_US
372911006	SNOMEDCT_US
96301002	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1060	TABLET	120 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1061	TABLET	80 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1062	TABLET	160 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1063	TABLET	240 mg	ORAL	ANDA	25 sections
Sorine	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0012	TABLET	80 mg	ORAL	ANDA	28 sections
Sorine	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0013	TABLET	120 mg	ORAL	ANDA	28 sections
Sorine	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0014	TABLET	160 mg	ORAL	ANDA	28 sections
Sorine	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0015	TABLET	240 mg	ORAL	ANDA	28 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0615-5552	TABLET	80 mg	ORAL	ANDA	24 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7143	TABLET	80 mg	ORAL	ANDA	25 sections
Sotalol	HUMAN PRESCRIPTION DRUG LABEL	1	10135-661	TABLET	80 mg	ORAL	ANDA	24 sections
Sotalol	HUMAN PRESCRIPTION DRUG LABEL	1	10135-662	TABLET	120 mg	ORAL	ANDA	24 sections
Sotalol	HUMAN PRESCRIPTION DRUG LABEL	1	10135-663	TABLET	160 mg	ORAL	ANDA	24 sections
Sotalol HydrochlorideAF	HUMAN PRESCRIPTION DRUG LABEL	1	10135-715	TABLET	80 mg	ORAL	ANDA	24 sections
Sotalol HydrochlorideAF	HUMAN PRESCRIPTION DRUG LABEL	1	10135-716	TABLET	120 mg	ORAL	ANDA	24 sections
Sotalol HydrochlorideAF	HUMAN PRESCRIPTION DRUG LABEL	1	10135-717	TABLET	160 mg	ORAL	ANDA	24 sections
sotalol hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	21695-397	TABLET	80 mg	ORAL	ANDA	19 sections
SOTYLIZE	HUMAN PRESCRIPTION DRUG LABEL	1	24338-530	SOLUTION	5 mg	ORAL	NDA	29 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	42806-121	TABLET	80 mg	ORAL	ANDA	14 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	42806-122	TABLET	120 mg	ORAL	ANDA	14 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	42806-123	TABLET	160 mg	ORAL	ANDA	14 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	43353-616	TABLET	80 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	50090-1299	TABLET	80 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	50268-724	TABLET	80 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	50268-724	TABLET	80 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	50268-725	TABLET	120 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	50268-725	TABLET	120 mg	ORAL	ANDA	25 sections
Sotalol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	53217-011	TABLET	80 mg	ORAL	ANDA	21 sections
sotalol hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	54868-4435	TABLET	80 mg	ORAL	ANDA	19 sections
sotalol hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5549	TABLET	160 mg	ORAL	ANDA	19 sections