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

Stem definitionDrug idCAS RN
bronchodilators, phenethylamine derivatives 2419 89365-50-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • serevent
  • salmeterol
  • salmeterol xinafoate
Salmeterol is a selective long acting beta2-adrenoceptor agonist. In vitro studies show salmeterol to be at least 50 times more selective for beta2-adrenoceptors than albuterol. Although beta2-adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-adrenoceptors are the predominant receptors in the heart, there are also beta2-adrenoceptors in the human heart comprising 10% to 50% of the total beta-adrenoceptors. The precise function of these receptors has not been established, but their presence raises the possibility that even selective beta2-agonists may have cardiac effects. The pharmacologic effects of beta2-adrenoceptor agonist drugs, including salmeterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. In vitro tests show that salmeterol is a potent and long-lasting inhibitor of the release of mast cell mediators, such as histamine, leukotrienes, and prostaglandin D2, from human lung. Salmeterol inhibits histamine-induced plasma protein extravasation and inhibits platelet-activating factor-induced eosinophil accumulation in the lungs of guinea pigs when administered by the inhaled route. In humans, single doses of salmeterol administered via inhalation aerosol attenuate allergen-induced bronchial hyper-responsiveness. It has received approval to be used in combination with fluticasone.
  • Molecular weight: 415.57
  • Formula: C25H37NO4
  • CLOGP: 3.06
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 4
  • TPSA: 81.95
  • ALOGS: -5.26
  • ROTB: 16

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.10 mg Inhal.aerosol
0.10 mg Inhal.powder

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.00 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
March 26, 2021 EMA TEVA B.V.
Feb. 4, 1994 FDA

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
Asthma 241.03 11.69 241 21508 89096 50494279
Chronic obstructive pulmonary disease 172.05 11.69 159 21590 53276 50530099
Dyspnoea 150.23 11.69 545 21204 547063 50036312
Eosinophilic granulomatosis with polyangiitis 123.17 11.69 42 21707 1913 50581462
Product quality issue 119.53 11.69 102 21647 30756 50552619
Chest discomfort 109.65 11.69 165 21584 92557 50490818
Wheezing 96.56 11.69 126 21623 61921 50521454
Cough 62.19 11.69 236 21513 241028 50342347
Bronchitis 61.20 11.69 137 21612 104022 50479353
Product complaint 55.11 11.69 43 21706 11423 50571952
Pneumonia 55.09 11.69 313 21436 378088 50205287
Dysphonia 52.89 11.69 74 21675 38818 50544557
Bronchospasm 51.26 11.69 46 21703 14808 50568567
Contraindicated product administered 49.01 11.69 4 21745 148954 50434421
Status asthmaticus 48.99 11.69 17 21732 816 50582559
Off label use 47.55 11.69 82 21667 474344 50109031
Completed suicide 42.14 11.69 4 21745 131885 50451490
Synovitis 38.94 11.69 4 21745 123861 50459514
Product use issue 37.62 11.69 9 21740 149466 50433909
Drug intolerance 33.54 11.69 27 21722 219077 50364298
Stress fracture 33.51 11.69 26 21723 6849 50576526
Throat irritation 30.40 11.69 50 21699 30189 50553186
Increased upper airway secretion 29.97 11.69 18 21731 3126 50580249
Laryngeal pain 29.92 11.69 20 21729 4179 50579196
Systemic lupus erythematosus 29.09 11.69 12 21737 140610 50442765
Dysmetropsia 24.93 11.69 6 21743 75 50583300
Myocardial infarction 23.61 11.69 88 21661 88939 50494436
Rheumatoid arthritis 23.10 11.69 32 21717 202518 50380857
Palpitations 23.08 11.69 91 21658 94415 50488960
Toxicity to various agents 22.83 11.69 35 21714 212464 50370911
Abdominal discomfort 22.26 11.69 41 21708 231600 50351775
Chest pain 22.22 11.69 141 21608 176741 50406634
Peripheral swelling 22.05 11.69 34 21715 205902 50377473
Erysipelas 21.89 11.69 20 21729 6588 50576787
Maternal exposure during pregnancy 21.68 11.69 22 21727 159756 50423619
Derealisation 21.47 11.69 10 21739 1036 50582339
Eczema impetiginous 20.79 11.69 4 21745 15 50583360
Infusion related reaction 20.13 11.69 26 21723 169531 50413844
Arthropathy 20.03 11.69 23 21726 157883 50425492
Neutropenia 19.37 11.69 21 21728 147944 50435431
Acute respiratory failure 19.33 11.69 40 21709 28742 50554633
Productive cough 19.22 11.69 58 21691 52636 50530739
International normalised ratio increased 19.16 11.69 51 21698 43101 50540274
Joint swelling 18.95 11.69 49 21700 245237 50338138
Varicella zoster oesophagitis 18.71 11.69 4 21745 28 50583347
Cortisol decreased 18.69 11.69 9 21740 1005 50582370
Anaphylactic reaction 18.33 11.69 58 21691 53997 50529378
Varicella zoster gastritis 18.13 11.69 4 21745 33 50583342
Diarrhoea 18.06 11.69 164 21585 588312 49995063
Cardiac failure congestive 18.04 11.69 78 21671 84304 50499071
Glossodynia 17.97 11.69 14 21735 115555 50467820
Anxiety 17.82 11.69 134 21615 177472 50405903
Haemoptysis 17.72 11.69 36 21713 25537 50557838
Fracture displacement 17.47 11.69 9 21740 1160 50582215
Kounis syndrome 17.43 11.69 9 21740 1166 50582209
Intentional overdose 17.30 11.69 3 21746 62501 50520874
Inhalation therapy 17.26 11.69 4 21745 42 50583333
Intentional product use issue 16.84 11.69 6 21743 76912 50506463
Product use in unapproved indication 16.81 11.69 15 21734 115804 50467571
Calculus bladder 16.73 11.69 7 21742 562 50582813
Granuloma 16.67 11.69 15 21734 4843 50578532
Emphysema 16.57 11.69 20 21729 9073 50574302
Peroneal nerve injury 16.48 11.69 4 21745 52 50583323
Respiratory failure 16.32 11.69 80 21669 91101 50492274
Adrenal insufficiency 16.31 11.69 25 21724 14218 50569157
Drug abuse 16.29 11.69 3 21746 59843 50523532
Febrile neutropenia 16.27 11.69 11 21738 97656 50485719
Therapeutic product effect decreased 16.00 11.69 21 21728 136029 50447346
Pericarditis 15.81 11.69 7 21742 78682 50504693
Oedema peripheral 15.74 11.69 119 21630 157842 50425533
Investigation 15.09 11.69 9 21740 1543 50581832
Candida infection 14.99 11.69 32 21717 23491 50559884
Emotional distress 14.94 11.69 36 21713 28627 50554748
Ecchymosis 14.79 11.69 20 21729 10149 50573226
Alopecia 14.65 11.69 55 21694 244992 50338383
Oligohydramnios 14.53 11.69 15 21734 5735 50577640
Myoclonic dystonia 14.43 11.69 3 21746 18 50583357
Nikolsky's sign 14.30 11.69 4 21745 93 50583282
Uterine hypertonus 14.21 11.69 5 21744 250 50583125
Tremor 14.05 11.69 91 21658 114812 50468563
Injury 13.50 11.69 49 21700 48876 50534499
Hypercapnia 13.40 11.69 13 21736 4614 50578761
Impaired healing 12.82 11.69 7 21742 69779 50513596
Choking 12.80 11.69 17 21732 8481 50574894
Urethral pain 12.75 11.69 5 21744 339 50583036
Drug ineffective 12.56 11.69 263 21486 819070 49764305
Lung disorder 12.47 11.69 45 21704 44754 50538621
Pharyngeal oedema 12.20 11.69 21 21728 13144 50570231
Musculoskeletal stiffness 12.10 11.69 23 21726 128458 50454917
Rash 12.08 11.69 125 21624 437346 50146029

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
Asthma 216.82 13.14 142 10740 33707 29529938
Chronic obstructive pulmonary disease 146.65 13.14 121 10761 40834 29522811
Eosinophilic granulomatosis with polyangiitis 105.17 13.14 33 10849 1353 29562292
Dyspnoea 92.37 13.14 296 10586 326436 29237209
Cerebral artery thrombosis 74.86 13.14 22 10860 720 29562925
Brain scan abnormal 71.91 13.14 22 10860 828 29562817
Pneumonia 66.19 13.14 262 10620 319910 29243735
Product complaint 50.74 13.14 29 10853 5376 29558269
Product quality issue 50.71 13.14 44 10838 15851 29547794
Areflexia 49.85 13.14 23 10859 2731 29560914
Status asthmaticus 49.46 13.14 13 10869 279 29563366
Toxicity to various agents 39.42 13.14 8 10874 173653 29389992
Wheezing 38.50 13.14 54 10828 33186 29530459
Hepatic cancer 31.61 13.14 23 10859 6433 29557212
Respiratory distress 29.77 13.14 47 10835 32059 29531586
Carcinoid tumour of the gastrointestinal tract 27.56 13.14 6 10876 55 29563590
Hemiplegia 26.76 13.14 21 10861 6573 29557072
Facial paralysis 25.48 13.14 24 10858 9605 29554040
Ischaemic stroke 24.80 13.14 30 10852 15947 29547698
Respiratory failure 24.50 13.14 85 10797 97046 29466599
Sinusitis 23.57 13.14 44 10838 34306 29529339
Benign prostatic hyperplasia 23.28 13.14 25 10857 11685 29551960
Cough 21.54 13.14 98 10784 126629 29437016
Oral candidiasis 21.51 13.14 23 10859 10699 29552946
Inhalation therapy 19.58 13.14 4 10878 26 29563619
Drug abuse 19.58 13.14 3 10879 79880 29483765
Cardiac failure congestive 17.57 13.14 65 10817 76516 29487129
Carcinoid tumour of the stomach 17.17 13.14 4 10878 51 29563594
Disease recurrence 17.16 13.14 25 10857 15889 29547756
Increased upper airway secretion 16.32 13.14 9 10873 1557 29562088
Product use in unapproved indication 15.96 13.14 6 10876 86869 29476776
Lipohypertrophy 15.74 13.14 5 10877 213 29563432
Bronchospasm 14.84 13.14 18 10864 9591 29554054
Off label use 14.69 13.14 59 10823 300741 29262904
Emphysema 14.64 13.14 17 10865 8654 29554991
Pseudomonas infection 14.64 13.14 19 10863 10833 29552812
Nightmare 13.89 13.14 19 10863 11398 29552247
Bronchitis 13.72 13.14 37 10845 36831 29526814
Cortisol abnormal 13.20 13.14 3 10879 34 29563611

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
Asthma 270.20 11.81 254 25161 94971 64378346
Eosinophilic granulomatosis with polyangiitis 228.00 11.81 72 25343 2810 64470507
Chronic obstructive pulmonary disease 217.90 11.81 198 25217 70850 64402467
Dyspnoea 155.30 11.81 625 24790 718049 63755268
Product quality issue 115.50 11.81 95 25320 29704 64443613
Chest discomfort 90.12 11.81 163 25252 115943 64357374
Pneumonia 84.06 11.81 438 24977 559138 63914179
Wheezing 82.38 11.81 128 25287 80451 64392866
Product complaint 65.86 11.81 47 25368 11907 64461410
Brain scan abnormal 63.55 11.81 22 25393 1146 64472171
Cerebral artery thrombosis 61.71 11.81 21 25394 1038 64472279
Bronchitis 60.65 11.81 133 25282 108610 64364707
Completed suicide 56.75 11.81 10 25405 224404 64248913
Toxicity to various agents 56.38 11.81 37 25378 363476 64109841
Status asthmaticus 55.65 11.81 19 25396 949 64472368
Cough 54.12 11.81 249 25166 301899 64171418
Off label use 44.17 11.81 117 25298 632689 63840628
Bronchospasm 38.34 11.81 45 25370 21637 64451680
Drug abuse 37.93 11.81 4 25411 132370 64340947
Treatment failure 34.87 11.81 3 25412 116813 64356504
Increased upper airway secretion 34.73 11.81 20 25395 3507 64469810
Areflexia 30.65 11.81 21 25394 4986 64468331
Dysphonia 28.45 11.81 59 25356 46323 64426994
Febrile neutropenia 27.85 11.81 20 25395 187637 64285680
Inhalation therapy 27.76 11.81 6 25409 49 64473268
Haemoptysis 26.20 11.81 59 25356 48989 64424328
Respiratory failure 26.00 11.81 129 25286 161054 64312263
Product use in unapproved indication 25.98 11.81 19 25396 176599 64296718
Cerebrovascular accident 25.77 11.81 115 25300 137468 64335849
Carcinoid tumour of the gastrointestinal tract 25.38 11.81 6 25409 76 64473241
Oral candidiasis 25.28 11.81 38 25377 23174 64450143
Dysmetropsia 24.76 11.81 6 25409 85 64473232
Intentional product use issue 24.64 11.81 4 25411 95360 64377957
Throat irritation 24.17 11.81 45 25370 32666 64440651
Stress fracture 24.05 11.81 19 25396 5605 64467712
Laryngeal pain 23.92 11.81 19 25396 5649 64467668
Cardiac failure congestive 23.59 11.81 108 25307 130472 64342845
Myocardial infarction 23.49 11.81 128 25287 165693 64307624
Palpitations 23.19 11.81 92 25323 104396 64368921
Drug intolerance 23.08 11.81 24 25391 187968 64285349
Contraindicated product administered 22.89 11.81 7 25408 107822 64365495
Productive cough 22.74 11.81 72 25343 73131 64400186
Erysipelas 21.54 11.81 22 25393 9059 64464258
Tremor 21.38 11.81 115 25300 148115 64325202
Cortisol decreased 20.60 11.81 11 25404 1666 64471651
Acute respiratory failure 20.22 11.81 54 25361 49880 64423437
Chest pain 19.37 11.81 159 25256 235821 64237496
Varicella zoster oesophagitis 19.05 11.81 4 25411 28 64473289
Rheumatoid arthritis 19.03 11.81 22 25393 164272 64309045
Derealisation 18.91 11.81 10 25405 1485 64471832
Intentional overdose 18.80 11.81 6 25409 89938 64383379
Respiratory distress 18.63 11.81 54 25361 52277 64421040
International normalised ratio increased 18.62 11.81 71 25344 79096 64394221
Varicella zoster gastritis 18.47 11.81 4 25411 33 64473284
Emphysema 18.21 11.81 25 25390 14044 64459273
Fracture displacement 18.05 11.81 9 25406 1182 64472135
Product use issue 17.91 11.81 20 25395 151695 64321622
Benign prostatic hyperplasia 17.85 11.81 20 25395 9145 64464172
Hepatic cancer 17.59 11.81 18 25397 7430 64465887
Facial paralysis 16.47 11.81 28 25387 18938 64454379
Diffuse panbronchiolitis 16.36 11.81 3 25412 9 64473308
Peroneal nerve injury 16.35 11.81 4 25411 59 64473258
Sinusitis 15.77 11.81 105 25310 145823 64327494
Granuloma 15.59 11.81 16 25399 6625 64466692
Malignant neoplasm progression 15.51 11.81 13 25402 112858 64360459
Hemiplegia 15.50 11.81 22 25393 12746 64460571
Hypercapnia 15.35 11.81 17 25398 7677 64465640
Infective pulmonary exacerbation of cystic fibrosis 15.32 11.81 21 25394 11775 64461542
Lipohypertrophy 15.09 11.81 7 25408 785 64472532
Uterine hypertonus 15.08 11.81 5 25410 228 64473089
Peripheral swelling 15.04 11.81 38 25377 209115 64264202
Calculus bladder 14.98 11.81 8 25407 1212 64472105
Anxiety 14.76 11.81 133 25282 202516 64270801
Maternal exposure during pregnancy 14.51 11.81 10 25405 95874 64377443
Pulseless electrical activity 14.08 11.81 21 25394 12718 64460599
Neutropenia 13.99 11.81 48 25367 239576 64233741
Central obesity 13.66 11.81 8 25407 1447 64471870
Eye irritation 13.23 11.81 23 25392 15833 64457484
Intentional product misuse 13.15 11.81 6 25409 72289 64401028
Swelling face 13.04 11.81 52 25363 59114 64414203
Lung hyperinflation 12.90 11.81 8 25407 1604 64471713
Emotional distress 12.64 11.81 37 25378 36001 64437316
COVID-19 12.50 11.81 5 25410 65135 64408182
Urethral pain 12.48 11.81 5 25410 392 64472925
Swollen tongue 12.37 11.81 36 25379 34918 64438399
Thrombocytopenia 12.28 11.81 46 25369 223755 64249562
Nightmare 12.05 11.81 26 25389 20967 64452350
Carcinoid tumour of the stomach 11.91 11.81 4 25411 190 64473127
Oedema peripheral 11.90 11.81 131 25284 210186 64263131
White blood cell count decreased 11.87 11.81 28 25387 157809 64315508
Diarrhoea 11.87 11.81 207 25208 722497 63750820

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R03AC12 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Selective beta-2-adrenoreceptor agonists
ATC R03AK06 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AK12 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
FDA MoA N0000009922 Adrenergic beta2-Agonists
MeSH PA D018663 Adrenergic Agents
MeSH PA D000322 Adrenergic Agonists
MeSH PA D058666 Adrenergic beta-2 Receptor Agonists
MeSH PA D000318 Adrenergic beta-Agonists
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D001993 Bronchodilator Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D019141 Respiratory System Agents
CHEBI has role CHEBI:35522 beta-adrenergic agonists
CHEBI has role CHEBI:35523 bronchodilator
FDA EPC N0000175779 beta2-Adrenergic Agonist

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Pulmonary emphysema indication 87433001
Non-allergic asthma indication 266361008 DOID:9360
Allergic asthma indication 389145006 DOID:9415
Adjunct Therapy to Achieve Long-term Asthma Control indication
Bronchospasm Prevention with COPD indication
Exercise-Induced Bronchospasm Prevention indication
COPD Associated with Chronic Bronchitis indication
Mycosis contraindication 3218000 DOID:1564
Disease caused by parasite contraindication 17322007
Glaucoma contraindication 23986001 DOID:1686
Acute tuberculosis contraindication 25629007
Hypertensive disorder contraindication 38341003 DOID:10763
Hypokalemia contraindication 43339004
Conduction disorder of the heart contraindication 44808001
Ketoacidosis contraindication 56051008
Osteoporosis contraindication 64859006 DOID:11476
Diabetes mellitus contraindication 73211009 DOID:9351
Hypopituitarism contraindication 74728003 DOID:9406
Candidiasis of mouth contraindication 79740000 DOID:14262
Hyperglycemia contraindication 80394007 DOID:4195
Thyrotoxicosis contraindication 90739004 DOID:7997
Bilateral cataracts contraindication 95722004
Prolonged QT interval contraindication 111975006
Seizure disorder contraindication 128613002
Ophthalmic herpes simplex contraindication 186542001
Exacerbation of asthma contraindication 281239006
Osteopenia contraindication 312894000
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Congenital long QT syndrome contraindication 442917000
Uncontrolled Bacterial Infections contraindication




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 10.07 acidic
pKa2 9.28 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO DIGIHALER TEVA PHARM N208799 July 12, 2019 RX POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO RESPICLICK TEVA PHARM N208799 Jan. 27, 2017 RX POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO DIGIHALER TEVA PHARM N208799 July 12, 2019 RX POWDER INHALATION 9415008 Oct. 6, 2034 TREATMENT OF ASTHMA
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO RESPICLICK TEVA PHARM N208799 Jan. 27, 2017 RX POWDER INHALATION 9415008 Oct. 6, 2034 TREATMENT OF ASTHMA
0.113MG/INH;EQ 0.014MG BASE/INH AIRDUO DIGIHALER TEVA PHARM N208799 July 12, 2019 RX POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA
0.113MG/INH;EQ 0.014MG BASE/INH AIRDUO RESPICLICK TEVA PHARM N208799 Jan. 27, 2017 RX POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA
0.232MG/INH;EQ 0.014MG BASE/INH AIRDUO DIGIHALER TEVA PHARM N208799 July 12, 2019 RX POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA
0.232MG/INH;EQ 0.014MG BASE/INH AIRDUO RESPICLICK TEVA PHARM N208799 Jan. 27, 2017 RX POWDER INHALATION 9066957 Oct. 6, 2034 TREATMENT OF ASTHMA

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO DIGIHALER TEVA PHARM N208799 July 12, 2019 RX POWDER INHALATION July 9, 2024 REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO RESPICLICK TEVA PHARM N208799 Jan. 27, 2017 RX POWDER INHALATION July 9, 2024 REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO DIGIHALER TEVA PHARM N208799 July 12, 2019 RX POWDER INHALATION Jan. 9, 2025 PEDIATRIC EXCLUSIVITY
0.055MG/INH;EQ 0.014MG BASE/INH AIRDUO RESPICLICK TEVA PHARM N208799 Jan. 27, 2017 RX POWDER INHALATION Jan. 9, 2025 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Beta-2 adrenergic receptor GPCR AGONIST Ki 9.41 CHEMBL CHEMBL
D(2) dopamine receptor GPCR Ki 4.50 CHEMBL
D(3) dopamine receptor GPCR Ki 5.98 CHEMBL
Aldehyde oxidase Enzyme IC50 5.00 WOMBAT-PK
Beta-3 adrenergic receptor GPCR EC50 6 CHEMBL
Beta-1 adrenergic receptor GPCR Ki 6.10 CHEMBL
Beta-2 adrenergic receptor GPCR EC50 7.50 CHEMBL
Beta-1 adrenergic receptor GPCR Ki 6.26 CHEMBL

External reference:

IDSource
4023955 VUID
N0000021960 NUI
D00687 KEGG_DRUG
94749-08-3 SECONDARY_CAS_RN
4020873 VANDF
4023955 VANDF
C0245531 UMLSCUI
CHEBI:9011 CHEBI
K5Y PDB_CHEM_ID
CHEMBL1263 ChEMBL_ID
CHEMBL1082607 ChEMBL_ID
D000068299 MESH_DESCRIPTOR_UI
DB00938 DRUGBANK_ID
5152 PUBCHEM_CID
559 IUPHAR_LIGAND_ID
5578 INN_ID
2I4BC502BT UNII
203159 RXNORM
1605 MMSL
21564 MMSL
5440 MMSL
d03759 MMSL
004036 NDDF
004037 NDDF
108605008 SNOMEDCT_US
108606009 SNOMEDCT_US
372515005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0054-0326 POWDER 50 ug RESPIRATORY (INHALATION) ANDA 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0054-0327 POWDER 50 ug RESPIRATORY (INHALATION) ANDA 28 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3607 POWDER, METERED 14 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3607 POWDER, METERED 14 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3608 POWDER, METERED 14 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3608 POWDER, METERED 14 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3609 POWDER, METERED 14 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
Fluticasone Propionate and Salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-3609 POWDER, METERED 14 ug RESPIRATORY (INHALATION) NDA authorized generic 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-7516 POWDER 50 ug RESPIRATORY (INHALATION) ANDA 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-7517 POWDER 50 ug RESPIRATORY (INHALATION) ANDA 28 sections
fluticasone propionate and salmeterol HUMAN PRESCRIPTION DRUG LABEL 2 0093-7518 POWDER 50 ug RESPIRATORY (INHALATION) ANDA 28 sections
SEREVENTDISKUS HUMAN PRESCRIPTION DRUG LABEL 1 0173-0520 POWDER, METERED 50 ug RESPIRATORY (INHALATION) NDA 29 sections
SEREVENTDISKUS HUMAN PRESCRIPTION DRUG LABEL 1 0173-0521 POWDER, METERED 50 ug RESPIRATORY (INHALATION) NDA 29 sections
SEREVENTDISKUS HUMAN PRESCRIPTION DRUG LABEL 1 0173-0521 POWDER, METERED 50 ug RESPIRATORY (INHALATION) NDA 29 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 0173-0695 POWDER 50 ug RESPIRATORY (INHALATION) NDA 27 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 0173-0695 POWDER 50 ug RESPIRATORY (INHALATION) NDA 27 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 0173-0696 POWDER 50 ug RESPIRATORY (INHALATION) NDA 27 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 0173-0696 POWDER 50 ug RESPIRATORY (INHALATION) NDA 27 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 0173-0697 POWDER 50 ug RESPIRATORY (INHALATION) NDA 27 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 0173-0697 POWDER 50 ug RESPIRATORY (INHALATION) NDA 27 sections
ADVAIR HFA HUMAN PRESCRIPTION DRUG LABEL 2 0173-0715 AEROSOL, METERED 21 ug RESPIRATORY (INHALATION) NDA 28 sections
ADVAIR HFA HUMAN PRESCRIPTION DRUG LABEL 2 0173-0715 AEROSOL, METERED 21 ug RESPIRATORY (INHALATION) NDA 28 sections
ADVAIR HFA HUMAN PRESCRIPTION DRUG LABEL 2 0173-0716 AEROSOL, METERED 21 ug RESPIRATORY (INHALATION) NDA 28 sections
ADVAIR HFA HUMAN PRESCRIPTION DRUG LABEL 2 0173-0716 AEROSOL, METERED 21 ug RESPIRATORY (INHALATION) NDA 28 sections
ADVAIR HFA HUMAN PRESCRIPTION DRUG LABEL 2 0173-0717 AEROSOL, METERED 21 ug RESPIRATORY (INHALATION) NDA 28 sections
ADVAIR HFA HUMAN PRESCRIPTION DRUG LABEL 2 0173-0717 AEROSOL, METERED 21 ug RESPIRATORY (INHALATION) NDA 28 sections
Wixela Inhub HUMAN PRESCRIPTION DRUG LABEL 2 0378-9320 POWDER 50 ug RESPIRATORY (INHALATION) ANDA 30 sections
Wixela Inhub HUMAN PRESCRIPTION DRUG LABEL 2 0378-9321 POWDER 50 ug RESPIRATORY (INHALATION) ANDA 30 sections
Wixela Inhub HUMAN PRESCRIPTION DRUG LABEL 2 0378-9322 POWDER 50 ug RESPIRATORY (INHALATION) ANDA 30 sections
ADVAIRDISKUS HUMAN PRESCRIPTION DRUG LABEL 2 21695-196 POWDER 50 ug RESPIRATORY (INHALATION) NDA 30 sections