sotalol ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
aromatic ring -CH(-OH)-CH2-NH-R 2464 3930-20-9

Description:

MoleculeDescription

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:

DoseUnitRoute
0.16 g O
0.16 g P

ADMET properties:

PropertyValueReference
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 ยตM/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:

DateAgencyCompanyOrphan
Oct. 30, 1992 FDA COVIS PHARMA SARL

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Torsade de pointes 307.65 14.76 115 14166 13236 63461505
Atrial fibrillation 231.50 14.76 199 14082 116437 63358304
Electrocardiogram QT prolonged 209.65 14.76 143 14138 59387 63415354
Bradycardia 121.41 14.76 113 14168 73114 63401627
Ventricular tachycardia 118.66 14.76 67 14214 19912 63454829
Drug interaction 110.10 14.76 190 14091 228941 63245800
Atrial tachycardia 95.71 14.76 36 14245 4204 63470537
International normalised ratio increased 83.46 14.76 75 14206 46350 63428391
Arrhythmia 71.29 14.76 63 14218 38077 63436664
Hyponatraemia 63.32 14.76 100 14181 111800 63362941
Hypotension 63.04 14.76 168 14113 272436 63202305
Sinus bradycardia 58.49 14.76 38 14243 14513 63460228
Palpitations 54.66 14.76 94 14187 112676 63362065
Cerebral haematoma 54.29 14.76 23 14258 3660 63471081
Urinary incontinence 50.31 14.76 48 14233 31966 63442775
Ischaemic stroke 49.03 14.76 37 14244 17920 63456821
Hyperkalaemia 47.89 14.76 60 14221 54143 63420598
Subarachnoid haemorrhage 47.11 14.76 33 14248 14250 63460491
Cardiospasm 45.99 14.76 17 14264 1890 63472851
Palmoplantar keratoderma 45.15 14.76 17 14264 1990 63472751
Cardio-respiratory arrest 44.62 14.76 61 14220 59898 63414843
Hepatocellular injury 42.92 14.76 41 14240 27340 63447401
Carotid artery occlusion 42.86 14.76 21 14260 4673 63470068
Erythromelalgia 41.37 14.76 9 14272 140 63474601
Syncope 40.90 14.76 85 14196 117300 63357441
Cardiac arrest 40.77 14.76 74 14207 92471 63382270
Pruritus genital 40.54 14.76 17 14264 2637 63472104
Sleep terror 40.38 14.76 17 14264 2663 63472078
Transient ischaemic attack 38.58 14.76 45 14236 37708 63437033
Tension headache 38.01 14.76 20 14261 5166 63469575
Cardiac disorder 36.76 14.76 51 14230 50765 63423976
Atrioventricular block 35.81 14.76 22 14259 7625 63467116
Presyncope 35.08 14.76 37 14244 27748 63446993
Atrial flutter 33.22 14.76 23 14258 9749 63464992
Asthenia 33.20 14.76 172 14109 383432 63091309
Inappropriate antidiuretic hormone secretion 31.83 14.76 27 14254 15435 63459306
Ventricular fibrillation 31.40 14.76 24 14257 11843 63462898
Apallic syndrome 31.38 14.76 10 14271 711 63474030
Systemic lupus erythematosus 30.85 14.76 5 14276 208913 63265828
Joint swelling 30.44 14.76 18 14263 327648 63147093
Anosmia 30.26 14.76 19 14262 6841 63467900
Drug intolerance 30.05 14.76 16 14265 308645 63166096
Acute kidney injury 30.01 14.76 128 14153 263287 63211454
Bundle branch block left 29.76 14.76 19 14262 7040 63467701
Localised oedema 29.15 14.76 17 14264 5361 63469380
Malaise 29.01 14.76 176 14105 415778 63058963
Ventricular arrhythmia 28.73 14.76 15 14266 3813 63470928
Contraindicated product administered 28.40 14.76 7 14274 217641 63257100
Long QT syndrome 27.95 14.76 14 14267 3265 63471476
Immunisation 26.45 14.76 10 14271 1183 63473558
Wound 26.25 14.76 3 14278 163260 63311481
Arthropathy 26.24 14.76 10 14271 234782 63239959
Subdural haematoma 25.44 14.76 23 14258 14305 63460436
Tachycardia 25.41 14.76 71 14210 118085 63356656
Melaena 24.27 14.76 32 14249 30333 63444408
Atrial rupture 23.96 14.76 5 14276 63 63474678
Gastrointestinal haemorrhage 23.95 14.76 55 14226 81121 63393620
Cardioactive drug level increased 23.61 14.76 11 14270 2189 63472552
Nasal mucosal erosion 23.54 14.76 5 14276 69 63474672
Rheumatoid arthritis 23.48 14.76 14 14267 253805 63220936
Sinus node dysfunction 23.27 14.76 14 14267 4671 63470070
Organising pneumonia 23 14.76 15 14266 5761 63468980
Pain 22.65 14.76 88 14193 740540 62734201
Haematoma 22.32 14.76 33 14248 34787 63439954
Hypersensitivity 22.08 14.76 20 14261 292665 63182076
Infusion related reaction 22.07 14.76 14 14267 245507 63229234
Heart rate increased 21.63 14.76 58 14223 94180 63380561
Cardiac failure congestive 21.32 14.76 57 14224 92376 63382365
Cardiac ablation 20.98 14.76 9 14272 1476 63473265
Infection 20.69 14.76 13 14268 229160 63245581
Electrocardiogram QRS complex prolonged 20.24 14.76 14 14267 5924 63468817
Product use issue 19.24 14.76 13 14268 220507 63254234
Anaemia macrocytic 18.93 14.76 11 14270 3443 63471298
Loss of consciousness 18.88 14.76 64 14217 118057 63356684
Facial pain 18.84 14.76 17 14264 10544 63464197
Eye pruritus 18.64 14.76 22 14259 18649 63456092
Hepatic cytolysis 18.53 14.76 20 14261 15387 63459354
Hypoglycaemia 18.05 14.76 41 14240 60024 63414717
Noninfective gingivitis 17.98 14.76 8 14273 1433 63473308
Mobility decreased 17.65 14.76 3 14278 121156 63353585
Pain of skin 17.44 14.76 17 14264 11617 63463124
Vasculitis 17.43 14.76 21 14260 18188 63456553
Fall 17.42 14.76 149 14132 392185 63082556
Musculoskeletal stiffness 17.33 14.76 10 14271 184608 63290133
Swelling 17.23 14.76 22 14259 275356 63199385
Disturbance in attention 16.12 14.76 30 14251 38159 63436582
Therapeutic product effect decreased 16.05 14.76 12 14269 193175 63281566
Haemorrhagic stroke 15.95 14.76 12 14269 5780 63468961
Diplopia 15.95 14.76 23 14258 23705 63451036
Discomfort 15.80 14.76 9 14272 167365 63307376
Blood glucose increased 15.76 14.76 48 14233 83708 63391033
Skin test positive 15.74 14.76 6 14275 726 63474015
Optic nerve infarction 15.61 14.76 3 14278 24 63474717
Cerebral congestion 15.40 14.76 3 14278 26 63474715
Blood loss anaemia 15.10 14.76 14 14267 8987 63465754
Resting tremor 15.06 14.76 6 14275 817 63473924

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Atrial fibrillation 196.33 14.63 231 12411 122162 34822127
Bradycardia 137.02 14.63 152 12490 75266 34869023
Ventricular tachycardia 105.76 14.63 83 12559 26496 34917793
Electrocardiogram QT prolonged 102.27 14.63 98 12544 40854 34903435
Torsade de pointes 91.61 14.63 47 12595 7162 34937127
Atrial flutter 60.55 14.63 48 12594 15526 34928763
Palpitations 50.30 14.63 67 12575 39919 34904370
Cardiogenic shock 48.83 14.63 54 12588 26564 34917725
Hypotension 42.95 14.63 176 12466 221473 34722816
Apallic syndrome 41.48 14.63 11 12631 249 34944040
Drug interaction 41.11 14.63 176 12466 225770 34718519
Arrhythmia 39.02 14.63 56 12586 35752 34908537
Atrial thrombosis 38.84 14.63 18 12624 2196 34942093
Antiacetylcholine receptor antibody positive 38.67 14.63 8 12634 57 34944232
Pacemaker generated rhythm 38.07 14.63 8 12634 62 34944227
Staring 35.64 14.63 15 12627 1455 34942834
Ventricular arrhythmia 35.20 14.63 23 12619 5505 34938784
Haemoptysis 34.19 14.63 52 12590 34954 34909335
International normalised ratio increased 33.72 14.63 61 12581 47266 34897023
Ischaemic stroke 33.42 14.63 37 12605 18213 34926076
Daydreaming 33.15 14.63 11 12631 549 34943740
Cardiac ablation 32.87 14.63 13 12629 1075 34943214
Pallor 32.50 14.63 43 12599 25437 34918852
Petit mal epilepsy 30.47 14.63 17 12625 3061 34941228
Loss of consciousness 28.74 14.63 80 12562 82587 34861702
Incontinence 27.07 14.63 20 12622 5827 34938462
Dissociation 24.56 14.63 12 12630 1646 34942643
Henoch-Schonlein purpura 24.53 14.63 12 12630 1650 34942639
Rectal haemorrhage 23.87 14.63 48 12594 40201 34904088
Long QT syndrome 23.78 14.63 14 12628 2789 34941500
Drug abuse 23.11 14.63 4 12638 99092 34845197
Presyncope 22.53 14.63 31 12611 19028 34925261
Xanthopsia 22.10 14.63 6 12636 149 34944140
BRASH syndrome 21.81 14.63 8 12634 538 34943751
Cardiac disorder 21.60 14.63 48 12594 43078 34901211
Sinus bradycardia 21.55 14.63 25 12617 12938 34931351
Heart rate abnormal 20.58 14.63 11 12631 1820 34942469
Brugada syndrome 18.84 14.63 8 12634 793 34943496
Cardiac failure congestive 18.38 14.63 69 12573 83201 34861088
Grandiosity 17.66 14.63 6 12636 322 34943967
Acquired haemophilia 17.06 14.63 8 12634 1002 34943287
Cardiac failure 16.46 14.63 71 12571 91177 34853112
Haematuria 15.97 14.63 47 12595 50019 34894270
Wolff-Parkinson-White syndrome 15.65 14.63 5 12637 221 34944068
Dyspnoea 15.60 14.63 206 12436 376576 34567713
Cardiac amyloidosis 15.44 14.63 8 12634 1243 34943046
Pressure of speech 15.25 14.63 6 12636 489 34943800
Treatment failure 15.05 14.63 44 12598 46653 34897636
Syncope 14.87 14.63 69 12573 91382 34852907
Pyrexia 14.86 14.63 66 12576 332947 34611342

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Torsade de pointes 376.00 13.10 159 23442 19153 79701634
Atrial fibrillation 345.14 13.10 355 23246 197531 79523256
Electrocardiogram QT prolonged 283.88 13.10 226 23375 90160 79630627
Bradycardia 235.69 13.10 243 23358 135314 79585473
Ventricular tachycardia 202.33 13.10 136 23465 41799 79678988
Drug interaction 135.10 13.10 345 23256 414838 79305949
International normalised ratio increased 101.10 13.10 125 23476 84596 79636191
Arrhythmia 92.46 13.10 102 23499 61170 79659617
Atrial flutter 92.15 13.10 65 23536 21560 79699227
Palpitations 88.93 13.10 145 23456 126465 79594322
Hypotension 86.19 13.10 306 23295 440011 79280776
Ischaemic stroke 83.44 13.10 73 23528 33058 79687729
Apallic syndrome 65.21 13.10 20 23581 948 79719839
Cardiogenic shock 61.88 13.10 69 23532 41845 79678942
Ventricular arrhythmia 61.02 13.10 36 23565 8804 79711983
Sinus bradycardia 56.40 13.10 52 23549 25195 79695592
Atrial tachycardia 54.42 13.10 31 23570 7102 79713685
Long QT syndrome 51.21 13.10 28 23573 5927 79714860
Syncope 48.97 13.10 140 23461 179309 79541478
Cerebral haematoma 48.76 13.10 30 23571 7912 79712875
Atrial thrombosis 48.40 13.10 23 23578 3633 79717154
Loss of consciousness 46.77 13.10 132 23469 167811 79552976
Acute kidney injury 40.16 13.10 277 23324 519127 79201660
Cardiac arrest 40.09 13.10 127 23474 171969 79548818
Pacemaker generated rhythm 39.34 13.10 8 23593 65 79720722
Antiacetylcholine receptor antibody positive 38.91 13.10 8 23593 69 79720718
Cardiac ablation 38.73 13.10 17 23584 2236 79718551
Cardiac disorder 37.85 13.10 69 23532 65688 79655099
Rectal haemorrhage 37.67 13.10 75 23526 76225 79644562
Presyncope 37.25 13.10 53 23548 41001 79679786
Inappropriate antidiuretic hormone secretion 36.59 13.10 42 23559 26271 79694516
Haemoptysis 36.42 13.10 62 23539 55937 79664850
Erythromelalgia 35.84 13.10 9 23592 201 79720586
Joint swelling 35.05 13.10 21 23580 288625 79432162
Ventricular fibrillation 34.71 13.10 45 23556 31881 79688906
Transient ischaemic attack 33.81 13.10 58 23543 52637 79668150
Cardiac failure congestive 33.08 13.10 105 23496 142297 79578490
Sinus node dysfunction 32.46 13.10 23 23578 7678 79713109
Haemorrhagic stroke 31.19 13.10 26 23575 11020 79709767
Asthenia 30.60 13.10 257 23344 511432 79209355
Urinary incontinence 30.25 13.10 48 23553 40861 79679926
Staring 30.08 13.10 15 23586 2630 79718157
Cardio-respiratory arrest 29.91 13.10 85 23516 108425 79612362
Daydreaming 29.81 13.10 11 23590 922 79719865
Gastrointestinal haemorrhage 28.21 13.10 102 23499 147617 79573170
Hyperkalaemia 28.08 13.10 86 23515 114312 79606475
Subarachnoid haemorrhage 27.40 13.10 35 23566 24430 79696357
Haematoma 26.59 13.10 52 23549 52143 79668644
Subdural haematoma 26.22 13.10 39 23562 31395 79689392
Hyponatraemia 26.05 13.10 113 23488 177735 79543052
Atrioventricular block 25.84 13.10 26 23575 14015 79706772
BRASH syndrome 25.34 13.10 10 23591 1007 79719780
Pain 25.17 13.10 115 23486 703687 79017100
Cardiospasm 24.25 13.10 14 23587 3287 79717500
Petit mal epilepsy 23.89 13.10 17 23584 5710 79715077
Atrial rupture 22.90 13.10 5 23596 59 79720728
Palmoplantar keratoderma 22.72 13.10 14 23587 3702 79717085
Hepatocellular injury 22.55 13.10 46 23555 47547 79673240
Melaena 22.22 13.10 53 23548 60837 79659950
Nasal mucosal erosion 22.18 13.10 5 23596 69 79720718
Arthralgia 21.90 13.10 91 23510 571712 79149075
Carotid artery occlusion 21.59 13.10 18 23583 7629 79713158
Rheumatoid arthritis 21.57 13.10 18 23583 208452 79512335
Organising pneumonia 21.51 13.10 21 23580 10918 79709869
Henoch-Schonlein purpura 21.27 13.10 12 23589 2698 79718089
Systemic lupus erythematosus 21.03 13.10 5 23596 121144 79599643
Pallor 20.95 13.10 46 23555 50016 79670771
Tachycardia 20.93 13.10 106 23495 177662 79543125
Tension headache 20.42 13.10 17 23584 7194 79713593
Sleep terror 20.39 13.10 14 23587 4444 79716343
Malaise 20.35 13.10 228 23373 489641 79231146
Pruritus genital 20.31 13.10 14 23587 4472 79716315
Infection 20.30 13.10 25 23576 241687 79479100
Heart rate increased 20.26 13.10 80 23521 120644 79600143
Arthropathy 19.97 13.10 14 23587 177097 79543690
Shock haemorrhagic 19.84 13.10 27 23574 20033 79700754
Fall 19.83 13.10 226 23375 487403 79233384
Mobility decreased 19.40 13.10 6 23595 122169 79598618
Dissociation 19.28 13.10 13 23588 4008 79716779
Blood loss anaemia 18.68 13.10 23 23578 15475 79705312
Acute pulmonary oedema 18.59 13.10 22 23579 14208 79706579
Xanthopsia 18.38 13.10 6 23595 349 79720438
Musculoskeletal stiffness 18.24 13.10 15 23586 174993 79545794
Left ventricular failure 18.11 13.10 18 23583 9563 79711224
Cerebrovascular accident 17.86 13.10 92 23509 155200 79565587
Cardioactive drug level increased 17.80 13.10 12 23589 3697 79717090
Hyperthyroidism 17.73 13.10 27 23574 22182 79698605
Asthma 17.58 13.10 9 23592 135086 79585701
Medication error 17.21 13.10 52 23549 68590 79652197
Dizziness 17.11 13.10 234 23367 526207 79194580
Incontinence 17.04 13.10 21 23580 14143 79706644
Brugada syndrome 17.04 13.10 8 23593 1230 79719557
Haemorrhage intracranial 17.02 13.10 29 23572 26164 79694623
Hypoglycaemia 16.78 13.10 67 23534 101527 79619260
Cardiac failure 16.61 13.10 90 23511 154752 79566035
Hypersensitivity 16.43 13.10 33 23568 262206 79458581
Junctional ectopic tachycardia 16.01 13.10 3 23598 15 79720772
Endodontic procedure 15.92 13.10 10 23591 2733 79718054
Therapeutic product effect decreased 15.92 13.10 15 23586 163848 79556939
Cardioversion 15.69 13.10 9 23592 2089 79718698
Grandiosity 15.43 13.10 6 23595 581 79720206
Haematuria 15.28 13.10 50 23551 68786 79652001
Localised oedema 15.14 13.10 15 23586 7937 79712850
Drug intolerance 15.09 13.10 35 23566 264084 79456703
Noninfective gingivitis 14.92 13.10 8 23593 1628 79719159
Stomatitis 14.77 13.10 13 23588 146744 79574043
Visual impairment 14.61 13.10 60 23541 92071 79628716
Venous pressure increased 14.28 13.10 3 23598 29 79720758
Pressure of speech 14.07 13.10 7 23594 1221 79719566
Discomfort 14.06 13.10 10 23591 125607 79595180
Cardiac amyloidosis 14.04 13.10 8 23593 1832 79718955
Cerebral haemorrhage 13.81 13.10 43 23558 57630 79663157
Anosmia 13.81 13.10 15 23586 8829 79711958
Acquired haemophilia 13.76 13.10 8 23593 1903 79718884
Heart rate irregular 13.64 13.10 30 23571 32649 79688138
Epistaxis 13.47 13.10 67 23534 111448 79609339
Disturbance in attention 13.22 13.10 39 23562 50762 79670025

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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|

DiseaseRelationSNOMED_IDDOID
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.95 acidic
pKa2 9.22 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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. 14, 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 10512620 Aug. 14, 2038 INTRAVENOUS SOTALOL DOSING REGIMEN FOR ACHIEVING STEADY STATE EXPOSURE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING
150MG/10ML (15MG/ML) SOTALOL HYDROCHLORIDE ALTATHERA PHARMS LLC N022306 July 2, 2009 RX SOLUTION INTRAVENOUS 11696902 Aug. 14, 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 INTRAVENOUS SOTALOL DOSING REGIMEN FOR USE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING
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
150MG/10ML (15MG/ML) SOTALOL HYDROCHLORIDE ALTATHERA PHARMS LLC N022306 July 2, 2009 RX SOLUTION INTRAVENOUS 11583216 Aug. 21, 2039 INTRAVENOUS SOTALOL DOSING REGIMEN FOR USE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Beta-1 adrenergic receptor GPCR ANTAGONIST Ki 6.10 WOMBAT-PK CHEMBL
Beta-2 adrenergic receptor GPCR ANTAGONIST Ki 6.90 WOMBAT-PK CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel BLOCKER Ki 4 WOMBAT-PK CHEMBL
Beta-2 adrenergic receptor GPCR Kd 6.24 CHEMBL
Beta-2 adrenergic receptor GPCR IC50 5.30 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-1060 TABLET 120 mg ORAL ANDA 25 sections
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 0093-1061 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 0093-1062 TABLET 160 mg ORAL ANDA 25 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-1063 TABLET 240 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