glycopyrronium bromide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
4302 596-51-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • sialanar
  • NVA237
  • Seebri Breezhaler
  • glycopyrronium bromide
  • copyrrolate
  • gastrodyn
  • glycopyrrolate
  • robanul
  • glycopyrronium
  • glycopyrrolate bromide
  • glycopyrronium tosilate
  • glycopyrronium tosilate hydrate
Glycopyrrolate is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical in vitro as well as in vivo studies, prevention of methacholine and acetylcholine induced bronchoconstrictive effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown. The bronchodilation following inhalation of glycopyrrolate is predominantly a site-specific effect.
  • Molecular weight: 318.44
  • Formula: C19H28NO3
  • CLOGP: 0.12
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 46.53
  • ALOGS: -5.57
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
3 mg O
0.30 mg P
3 mg R
44 mcg Inhal.powder

ADMET properties:

PropertyValueReference
BA (Bioavailability) 17 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.37 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 16.80 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.65 hours Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.48 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -0.904 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.766 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.368 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 2.547 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 76.230 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 66.250 % High 1
herg hERG pIC50 4.298 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.091 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.311 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 76.310 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CG,PRKDC,TEK,TGFBR1 22
kinase-selectivity-class AXL,GRK2,PDK4 3
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 1.125 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.798 High 1
mh-clint Mouse hepatocyte intrinsic clearance 19.543 High 1
mppb Mouse plasma protein binding (% unbound) 63.580 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.169 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 73.500 % High 1
rat-kpuu-brain Rat brain Kpuu 0.015 % High 1
rh-clint Rat hepatocyte intrinsic clearance 23.605 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 89.130 % High 1
rppb Rat plasma protein binding (% unbound) 68.730 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 928.966 uM High 1

Approvals:

DateAgencyCompanyOrphan
Aug. 11, 1961 FDA SHIONOGI INC
June 18, 2019 PMDA AstraZeneca K.K.
Sept. 28, 2012 EMA Novartis Europharm Limited

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
Total lung capacity increased 566.07 17.72 148 21546 4873 90601880
Asthma-chronic obstructive pulmonary disease overlap syndrome 469.52 17.72 127 21567 4772 90601981
Wheezing 468.91 17.72 415 21279 237665 90369088
Bronchiectasis 445.01 17.72 176 21518 22154 90584599
Asthma 439.18 17.72 403 21291 241757 90364996
Nasal polyps 420.86 17.72 140 21554 10740 90596013
Obstructive airways disorder 396.62 17.72 169 21525 25700 90581053
Sarcoidosis 360.30 17.72 124 21570 10549 90596204
Chronic obstructive pulmonary disease 325.82 17.72 209 21485 73620 90533133
Rhinitis allergic 312.50 17.72 126 21568 16659 90590094
Lung neoplasm malignant 302.18 17.72 137 21557 24136 90582617
Cardiac murmur 295.95 17.72 124 21570 18070 90588683
Cough 260.39 17.72 377 21317 368585 90238168
Dyspnoea 231.26 17.72 590 21104 880365 89726388
Forced expiratory volume decreased 225.61 17.72 75 21619 5733 90601020
Jaundice cholestatic 224.21 17.72 86 21608 9957 90596796
Hypomania 223.30 17.72 83 21611 8814 90597939
Nasal congestion 199.69 17.72 163 21531 83251 90523502
Schizophrenia 197.75 17.72 88 21606 14826 90591927
Blood immunoglobulin E increased 187.40 17.72 61 21633 4364 90602389
Sputum discoloured 180.27 17.72 91 21603 20300 90586453
Productive cough 168.66 17.72 143 21551 76920 90529833
Malignant mediastinal neoplasm 165.88 17.72 43 21651 1365 90605388
Stress cardiomyopathy 149.34 17.72 70 21624 13285 90593468
Psychotic disorder 149.09 17.72 93 21601 31137 90575616
Full blood count abnormal 142.77 17.72 96 21598 36501 90570252
Respiration abnormal 142.07 17.72 58 21636 7905 90598848
Bronchial neoplasm 139.61 17.72 31 21663 499 90606254
Bronchial haemorrhage 133.17 17.72 31 21663 622 90606131
Sleep apnoea syndrome 130.40 17.72 86 21608 31661 90575092
Blood bilirubin increased 130.12 17.72 97 21597 43373 90563380
Nasal turbinate hypertrophy 122.57 17.72 31 21663 890 90605863
Endometrial ablation 119.16 17.72 31 21663 998 90605755
Chest discomfort 117.67 17.72 155 21539 138210 90468543
Bronchial disorder 115.50 17.72 33 21661 1517 90605236
Gastrooesophageal reflux disease 112.62 17.72 167 21527 166170 90440583
Pneumonia 108.54 17.72 367 21327 637692 89969061
Hyper IgE syndrome 108.43 17.72 25 21669 480 90606273
Hepatotoxicity 108.41 17.72 89 21605 45753 90561000
Glaucoma 107.19 17.72 65 21629 20690 90586063
Rhonchi 102.02 17.72 35 21659 2943 90603810
Cholelithiasis 97.92 17.72 89 21605 52417 90554336
Rhinorrhoea 97.75 17.72 113 21581 88203 90518550
Heart sounds 97.25 17.72 27 21667 1117 90605636
Alopecia 94.90 17.72 6 21688 495065 90111688
Prolonged expiration 94.73 17.72 27 21667 1230 90605523
Frustration tolerance decreased 93.29 17.72 43 21651 7853 90598900
Pain 91.01 17.72 64 21630 996277 89610476
Infusion related reaction 86.47 17.72 3 21691 416777 90189976
Restrictive pulmonary disease 85.77 17.72 29 21665 2333 90604420
Sleep disorder due to a general medical condition 83.74 17.72 76 21618 44662 90562091
Humidity intolerance 80.70 17.72 19 21675 401 90606352
Rhinitis 79.21 17.72 46 21648 13526 90593227
Peak expiratory flow rate decreased 72.69 17.72 19 21675 623 90606130
Dyspnoea exertional 69.31 17.72 86 21608 72202 90534551
Rales 67.72 17.72 44 21650 15783 90590970
Secretion discharge 67.55 17.72 44 21650 15852 90590901
Joint swelling 66.62 17.72 19 21675 503281 90103472
Rash 65.18 17.72 57 21637 796043 89810710
Granuloma 64.79 17.72 31 21663 6154 90600599
Systemic lupus erythematosus 64.76 17.72 6 21688 361890 90244863
Breath sounds abnormal 63.94 17.72 42 21652 15344 90591409
Oedema peripheral 63.19 17.72 169 21525 257746 90349007
Breast cancer recurrent 62.00 17.72 29 21665 5474 90601279
Middle insomnia 60.70 17.72 42 21652 16709 90590044
Depressive symptom 60.00 17.72 28 21666 5257 90601496
Oxygen saturation decreased 58.91 17.72 98 21596 107385 90499368
Affective disorder 58.01 17.72 31 21663 7762 90598991
Synovitis 55.09 17.72 7 21687 329745 90277008
Influenza 54.79 17.72 110 21584 139154 90467599
Pulmonary function test decreased 54.74 17.72 25 21669 4469 90602284
Drug intolerance 52.09 17.72 21 21673 447570 90159183
Treatment failure 51.88 17.72 6 21688 303922 90302831
Rheumatoid arthritis 51.19 17.72 12 21682 362602 90244151
Appetite disorder 50.78 17.72 30 21664 9103 90597650
Pulmonary congestion 50.75 17.72 40 21654 19393 90587360
Therapeutic product effect incomplete 49.44 17.72 129 21565 193767 90412986
Polycystic ovaries 49.27 17.72 25 21669 5629 90601124
Therapeutic product effect decreased 48.60 17.72 5 21689 277566 90329187
Seizure 47.90 17.72 110 21584 152519 90454234
Pulmonary oedema 47.32 17.72 66 21628 62014 90544739
Increased bronchial secretion 46.48 17.72 18 21676 2135 90604618
Lung diffusion test decreased 45.76 17.72 14 21680 817 90605936
Swelling 45.07 17.72 22 21672 419036 90187717
Forced vital capacity decreased 44.90 17.72 15 21679 1163 90605590
Sinus tachycardia 44.85 17.72 44 21650 28469 90578284
Impaired healing 44.34 17.72 3 21691 234196 90372557
Arthralgia 41.58 17.72 77 21617 778445 89828308
Blister 41.19 17.72 6 21688 254992 90351761
Acute pulmonary oedema 39.44 17.72 26 21668 9554 90597199
Choking 38.58 17.72 28 21666 12005 90594748
Diarrhoea 37.95 17.72 108 21586 939082 89667671
Lower respiratory tract infection 37.92 17.72 139 21555 250520 90356233
Helicobacter infection 37.43 17.72 5 21689 226845 90379908
Pulmonary thrombosis 36.56 17.72 25 21669 9757 90596996
Bronchial obstruction 36.03 17.72 14 21680 1675 90605078
Dyslipidaemia 35.82 17.72 25 21669 10082 90596671
Nail dystrophy 35.66 17.72 13 21681 1305 90605448
Tachycardia 35.27 17.72 100 21594 157573 90449180
Lung neoplasm 34.53 17.72 21 21673 6714 90600039
Dystonia 34.29 17.72 30 21664 16789 90589964
Angioplasty 34.22 17.72 13 21681 1464 90605289
Restless legs syndrome 34.09 17.72 34 21660 22436 90584317
Coronary artery disease 33.83 17.72 41 21653 33582 90573171
Hypoventilation 33.71 17.72 19 21675 5277 90601476
Irritable bowel syndrome 33.23 17.72 5 21689 207443 90399310
Laryngitis fungal 33.04 17.72 8 21686 191 90606562
Blood pressure systolic increased 33.03 17.72 54 21640 58291 90548462
Bronchial wall thickening 32.89 17.72 14 21680 2117 90604636
Brain injury 31.85 17.72 21 21673 7717 90599036
Stomatitis 31.75 17.72 13 21681 274685 90332068
Ankle fracture 31.23 17.72 31 21663 20339 90586414
Nasal inflammation 31.03 17.72 10 21684 692 90606061
Bronchospasm paradoxical 30.84 17.72 7 21687 125 90606628
Blood test abnormal 30.50 17.72 31 21663 20921 90585832
Abdominal discomfort 30.35 17.72 42 21652 477286 90129467
Body temperature abnormal 30.14 17.72 14 21680 2601 90604152
Loss of personal independence in daily activities 30.12 17.72 86 21608 136019 90470734
Laryngospasm 29.81 17.72 15 21679 3318 90603435
Staphylococcal scalded skin syndrome 29.59 17.72 7 21687 151 90606602
Sneezing 29.36 17.72 36 21658 29833 90576920
Oropharyngitis fungal 29.13 17.72 6 21688 66 90606687
Staphylococcus test positive 28.78 17.72 16 21678 4329 90602424
Urinary retention 28.57 17.72 40 21654 37704 90569049
Axillary pain 28.54 17.72 13 21681 2308 90604445
Paranoia 28.30 17.72 24 21670 12884 90593869
Respiratory rate increased 27.64 17.72 26 21668 15975 90590778
Granulomatosis with polyangiitis 27.21 17.72 13 21681 2572 90604181
Discomfort 27.13 17.72 16 21678 274319 90332434
Dysphonia 26.20 17.72 51 21643 63033 90543720
Apnoea 25.93 17.72 20 21674 9394 90597359
Brachial plexopathy 25.91 17.72 7 21687 261 90606492
Abscess 25.78 17.72 27 21667 18864 90587889
C-reactive protein increased 25.58 17.72 6 21688 181383 90425370
Peripheral vascular disorder 25.38 17.72 17 21677 6414 90600339
Anaphylactic reaction 25.18 17.72 61 21633 87463 90519290
Maternal exposure during delivery 25.03 17.72 14 21680 3832 90602921
Vulvovaginal candidiasis 24.85 17.72 14 21680 3886 90602867
Musculoskeletal stiffness 24.46 17.72 21 21673 296511 90310242
Condition aggravated 24.22 17.72 233 21461 595312 90011441
General physical health deterioration 23.83 17.72 30 21664 355085 90251668
Diplegia 23.79 17.72 10 21684 1465 90605288
Respiratory symptom 23.72 17.72 14 21680 4238 90602515
Flank pain 23.64 17.72 26 21668 19196 90587557
Confusional state 23.53 17.72 35 21659 386170 90220583
Musculoskeletal pain 23.49 17.72 6 21688 171245 90435508
Sleep disorder 23.48 17.72 9 21685 198021 90408732
Opisthotonus 23.37 17.72 7 21687 380 90606373
Catheter site haemorrhage 22.92 17.72 13 21681 3655 90603098
Drug ineffective 22.81 17.72 217 21477 1384081 89222672
Crepitations 22.64 17.72 18 21676 8834 90597919
Depression 22.63 17.72 136 21558 300465 90306288
Pancreatic mass 22.21 17.72 9 21685 1202 90605551
Drug hypersensitivity 22.01 17.72 49 21645 463560 90143193
Cerebral thrombosis 21.86 17.72 10 21684 1793 90604960
Smoke sensitivity 21.52 17.72 7 21687 499 90606254
Bursitis 21.48 17.72 3 21691 131651 90475102
Osteoarthritis 21.44 17.72 10 21684 195720 90411033
Ill-defined disorder 20.95 17.72 9 21685 184882 90421871
Sleep disorder due to general medical condition, insomnia type 20.84 17.72 3 21691 128691 90478062
Blood cholesterol increased 20.75 17.72 12 21682 208000 90398753
Respiratory disorder 20.63 17.72 47 21647 64769 90541984
Muscle disorder 20.47 17.72 14 21680 5465 90601288
Infective exacerbation of chronic obstructive airways disease 20.44 17.72 9 21685 1477 90605276
Appendicitis 20.36 17.72 18 21676 10213 90596540
Blood disorder 20.26 17.72 16 21678 7774 90598979
Seasonal allergy 19.89 17.72 26 21668 22957 90583796
Neutropenia 19.70 17.72 15 21679 224889 90381864
Abdominal pain 19.46 17.72 41 21653 395680 90211073
Respiratory rate decreased 19.35 17.72 12 21682 3971 90602782
Respiratory failure 19.01 17.72 67 21627 118351 90488402
Wound 18.89 17.72 27 21667 302953 90303800
Weight decreased 18.69 17.72 155 21539 379755 90226998
Stress 18.56 17.72 52 21642 81343 90525410
Adverse event 18.41 17.72 3 21691 117415 90489338
Conjunctivitis 18.30 17.72 27 21667 26679 90580074
Heart rate increased 18.23 17.72 64 21630 112838 90493915
Mite allergy 18.05 17.72 7 21687 833 90605920
Peripheral swelling 17.75 17.72 46 21648 413060 90193693

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 252.37 17.53 183 12748 62131 42546273
Wheezing 208.45 17.53 155 12776 54626 42553778
Productive cough 174.31 17.53 136 12795 51431 42556973
Dyspnoea 156.19 17.53 384 12547 442237 42166167
Obstructive airways disorder 128.97 17.53 85 12846 24674 42583730
Full blood count abnormal 125.91 17.53 90 12841 29786 42578618
Sputum discoloured 118.52 17.53 59 12872 10073 42598331
Chronic obstructive pulmonary disease 107.09 17.53 113 12818 63001 42545403
Cough 103.66 17.53 190 12741 177913 42430491
Asthma-chronic obstructive pulmonary disease overlap syndrome 103.37 17.53 32 12899 1527 42606877
Pulmonary function test abnormal 89.90 17.53 33 12898 2661 42605743
Gastrooesophageal reflux disease 86.09 17.53 86 12845 44937 42563467
Chest discomfort 84.06 17.53 100 12831 63516 42544888
Therapeutic product effect incomplete 83.20 17.53 105 12826 70834 42537570
Adjustment disorder 82.51 17.53 26 12905 1316 42607088
Eosinophil count increased 76.38 17.53 45 12886 10718 42597686
Sleep disorder due to a general medical condition 72.17 17.53 52 12879 17401 42591003
Rhinitis perennial 67.50 17.53 15 12916 188 42608216
Dyspnoea exertional 64.86 17.53 78 12853 50070 42558334
Tachycardia 62.70 17.53 111 12820 100976 42507428
Bronchial hyperreactivity 62.04 17.53 23 12908 1906 42606498
Eosinophilic granulomatosis with polyangiitis 60.99 17.53 36 12895 8602 42599802
Forced expiratory volume decreased 59.71 17.53 34 12897 7596 42600808
Blood immunoglobulin E increased 57.36 17.53 26 12905 3599 42604805
Respiratory disorder 47.46 17.53 45 12886 22040 42586364
Loss of personal independence in daily activities 46.50 17.53 66 12865 49750 42558654
Prolonged expiration 46.02 17.53 12 12919 305 42608099
Serotonin syndrome 45.07 17.53 47 12884 25798 42582606
Angle closure glaucoma 42.13 17.53 15 12916 1107 42607297
Dehiscence 41.73 17.53 13 12918 633 42607771
Upper respiratory tract infection 41.03 17.53 57 12874 42116 42566288
Rhinitis allergic 40.90 17.53 21 12910 3821 42604583
Smoke sensitivity 40.53 17.53 10 12921 202 42608202
Drug dependence 40.48 17.53 47 12884 29047 42579357
Ischaemic cardiomyopathy 40.41 17.53 25 12906 6497 42601907
Heat stroke 38.55 17.53 14 12917 1094 42607310
Perfume sensitivity 37.73 17.53 9 12922 157 42608247
Emphysema 37.30 17.53 30 12901 11805 42596599
Salivary hypersecretion 37.20 17.53 29 12902 10914 42597490
Breath sounds abnormal 36.74 17.53 30 12901 12063 42596341
Vasculitis 36.73 17.53 36 12895 18358 42590046
Sputum purulent 36.43 17.53 12 12919 700 42607704
Dyspnoea at rest 36.14 17.53 20 12911 4229 42604175
Precancerous condition 34.79 17.53 8 12923 118 42608286
Haemoptysis 34.30 17.53 55 12876 46112 42562292
Orthostatic hypertension 32.40 17.53 10 12921 472 42607932
Discomfort 32.21 17.53 39 12892 25180 42583224
Cardiomyopathy 31.82 17.53 34 12897 19176 42589228
Middle insomnia 31.60 17.53 23 12908 7810 42600594
Hypercholesterolaemia 31.13 17.53 28 12903 12821 42595583
Drug intolerance 30.40 17.53 72 12859 80352 42528052
Saliva altered 30.32 17.53 8 12923 213 42608191
Dyspnoea paroxysmal nocturnal 30.08 17.53 13 12918 1607 42606797
Bradycardia 29.61 17.53 74 12857 85410 42522994
Umbilical hernia 29.06 17.53 19 12912 5428 42602976
Obesity 28.81 17.53 30 12901 16429 42591975
Disease recurrence 28.69 17.53 40 12891 29638 42578766
Off label use 26.60 17.53 102 12829 638233 41970171
Accelerated idioventricular rhythm 26.48 17.53 7 12924 188 42608216
Cardiorenal syndrome 26.36 17.53 10 12921 883 42607521
Paraesthesia 24.82 17.53 63 12868 73396 42535008
Carboxyhaemoglobin increased 23.18 17.53 5 12926 54 42608350
Pseudomonal sepsis 23.11 17.53 15 12916 4234 42604170
Parkinsonian rest tremor 22.81 17.53 7 12924 324 42608080
Occupational exposure to air contaminants 22.52 17.53 6 12925 166 42608238
Forced vital capacity decreased 22.36 17.53 9 12922 931 42607473
Physical deconditioning 22.34 17.53 12 12919 2393 42606011
Hypoxia 21.67 17.53 58 12873 69728 42538676
Infective exacerbation of chronic obstructive airways disease 21.31 17.53 11 12920 2022 42606382
Mydriasis 21.02 17.53 19 12912 8751 42599653
Volume blood decreased 20.47 17.53 6 12925 237 42608167
Expiratory reserve volume decreased 19.61 17.53 5 12926 116 42608288
Lung diffusion test decreased 19.48 17.53 8 12923 871 42607533
Pulmonary mass 18.91 17.53 24 12907 16241 42592163
Laryngospasm 18.69 17.53 10 12921 1978 42606426
Proctitis bacterial 18.61 17.53 5 12926 143 42608261
Bronchiectasis 18.49 17.53 25 12906 17994 42590410
Appendicitis perforated 18.15 17.53 10 12921 2096 42606308
Nasal congestion 17.74 17.53 32 12899 29469 42578935
Orthopnoea 17.64 17.53 14 12917 5403 42603001

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 600.94 15.70 531 31584 249760 110307424
Wheezing 562.45 15.70 516 31599 254714 110302470
Total lung capacity increased 539.54 15.70 149 31966 4963 110552221
Asthma-chronic obstructive pulmonary disease overlap syndrome 520.95 15.70 152 31963 6192 110550992
Obstructive airways disorder 458.01 15.70 237 31878 45912 110511272
Chronic obstructive pulmonary disease 393.60 15.70 294 31821 108864 110448320
Bronchiectasis 375.31 15.70 192 31923 36301 110520883
Nasal polyps 353.48 15.70 136 31979 13064 110544120
Rhinitis allergic 346.29 15.70 146 31969 17776 110539408
Sarcoidosis 327.57 15.70 127 31988 12452 110544732
Cough 326.77 15.70 524 31591 461117 110096067
Dyspnoea 318.41 15.70 866 31249 1106006 109451178
Productive cough 307.10 15.70 259 31856 114046 110443138
Sputum discoloured 281.44 15.70 145 31970 27800 110529384
Forced expiratory volume decreased 243.44 15.70 104 32011 13072 110544112
Lung neoplasm malignant 241.99 15.70 140 31975 33702 110523482
Cardiac murmur 239.99 15.70 125 31990 24503 110532681
Full blood count abnormal 224.56 15.70 161 31954 55891 110501293
Blood immunoglobulin E increased 210.75 15.70 80 32035 7402 110549782
Hypomania 203.31 15.70 85 32030 10125 110547059
Nasal congestion 197.23 15.70 189 31926 98093 110459091
Gastrooesophageal reflux disease 194.16 15.70 250 31865 179726 110377458
Jaundice cholestatic 189.28 15.70 90 32025 14518 110542666
Chest discomfort 154.76 15.70 220 31895 173628 110383556
Malignant mediastinal neoplasm 153.88 15.70 42 32073 1336 110555848
Schizophrenia 152.59 15.70 89 32026 21737 110535447
Bronchial neoplasm 133.29 15.70 31 32084 505 110556679
Prolonged expiration 130.99 15.70 38 32077 1514 110555670
Respiration abnormal 125.75 15.70 60 32055 9749 110547435
Stress cardiomyopathy 122.66 15.70 69 32046 15737 110541447
Nasal turbinate hypertrophy 119.30 15.70 31 32084 813 110556371
Sleep apnoea syndrome 117.54 15.70 96 32019 40351 110516833
Dyspnoea exertional 115.98 15.70 147 31968 103913 110453271
Endometrial ablation 115.73 15.70 31 32084 917 110556267
Bronchial haemorrhage 104.06 15.70 31 32084 1356 110555828
Sleep disorder due to a general medical condition 102.19 15.70 99 32016 52013 110505171
Rhinorrhoea 101.92 15.70 137 31978 102529 110454655
Glaucoma 100.19 15.70 69 32046 22448 110534736
Psychotic disorder 98.44 15.70 96 32019 50841 110506343
Breath sounds abnormal 97.20 15.70 71 32044 25333 110531851
Hyper IgE syndrome 96.20 15.70 25 32090 656 110556528
Bronchial disorder 94.05 15.70 34 32081 2742 110554442
Pneumonia 93.69 15.70 501 31614 876213 109680971
Heart sounds 92.11 15.70 27 32088 1116 110556068
Tachycardia 89.50 15.70 201 31914 226444 110330740
Rhonchi 87.89 15.70 37 32078 4481 110552703
Blood bilirubin increased 87.31 15.70 109 32006 75863 110481321
Pain 86.59 15.70 90 32025 954865 109602319
Restrictive pulmonary disease 85.17 15.70 33 32082 3226 110553958
Middle insomnia 84.62 15.70 60 32055 20442 110536742
Cholelithiasis 84.34 15.70 98 32017 63324 110493860
Frustration tolerance decreased 81.29 15.70 43 32072 8688 110548496
Therapeutic product effect incomplete 81.22 15.70 192 31923 223613 110333571
Pulmonary function test abnormal 77.85 15.70 35 32080 4965 110552219
Alopecia 77.41 15.70 8 32107 364745 110192439
Infusion related reaction 76.81 15.70 10 32105 381152 110176032
Hepatotoxicity 76.12 15.70 93 32022 63307 110493877
Humidity intolerance 73.76 15.70 19 32096 481 110556703
Joint swelling 69.73 15.70 21 32094 442824 110114360
Rash 68.21 15.70 83 32032 820881 109736303
Eosinophilic granulomatosis with polyangiitis 67.95 15.70 41 32074 10645 110546539
Peak expiratory flow rate decreased 67.42 15.70 19 32096 681 110556503
Forced vital capacity decreased 66.26 15.70 24 32091 1946 110555238
Rhinitis perennial 66.03 15.70 15 32100 219 110556965
Oedema peripheral 65.39 15.70 227 31888 328433 110228751
Eosinophil count increased 61.21 15.70 50 32065 21008 110536176
Lung diffusion test decreased 58.69 15.70 21 32094 1644 110555540
Contraindicated product administered 56.60 15.70 4 32111 248263 110308921
Bronchial hyperreactivity 55.79 15.70 25 32090 3519 110553665
Synovitis 55.66 15.70 7 32108 274085 110283099
Secretion discharge 54.54 15.70 46 32069 20198 110536986
Arthropathy 54.53 15.70 9 32106 287513 110269671
Pulmonary function test decreased 54.34 15.70 33 32082 8667 110548517
Treatment failure 54.12 15.70 8 32107 277226 110279958
Smoke sensitivity 53.68 15.70 16 32099 701 110556483
Systemic lupus erythematosus 52.87 15.70 6 32109 254332 110302852
Pericarditis 51.52 15.70 3 32112 219111 110338073
Hypoventilation 51.37 15.70 31 32084 8050 110549134
Rhinitis 50.25 15.70 46 32069 22499 110534685
Polycystic ovaries 48.59 15.70 25 32090 4771 110552413
Rales 48.49 15.70 47 32068 24692 110532492
Rheumatoid arthritis 47.51 15.70 14 32101 299599 110257585
Loss of personal independence in daily activities 47.29 15.70 122 31993 149898 110407286
Granuloma 46.80 15.70 31 32084 9459 110547725
Respiratory disorder 46.14 15.70 78 32037 71304 110485880
Swelling 44.79 15.70 23 32092 351018 110206166
Salivary hypersecretion 43.70 15.70 38 32077 17383 110539801
Appetite disorder 43.60 15.70 30 32085 9739 110547445
Laryngospasm 43.48 15.70 23 32092 4645 110552539
Depressive symptom 42.74 15.70 28 32087 8386 110548798
Impaired healing 42.53 15.70 4 32111 196713 110360471
Affective disorder 42.06 15.70 31 32084 11210 110545974
Oxygen saturation decreased 41.82 15.70 120 31995 156862 110400322
Therapeutic product effect decreased 41.41 15.70 10 32105 244306 110312878
Lower respiratory tract infection 40.81 15.70 159 31956 242947 110314237
Pulmonary oedema 40.50 15.70 90 32025 100569 110456615
Orthostatic hypertension 40.08 15.70 14 32101 1021 110556163
Influenza 40.05 15.70 124 31991 168977 110388207
Choking 40.02 15.70 34 32081 15076 110542108
Perfume sensitivity 39.36 15.70 14 32101 1077 110556107
Ischaemic cardiomyopathy 39.09 15.70 26 32089 7985 110549199
Angle closure glaucoma 37.66 15.70 19 32096 3480 110553704
Upper respiratory tract infection 37.54 15.70 103 32012 131225 110425959
Seizure 37.40 15.70 145 31970 221040 110336144
Diarrhoea 36.94 15.70 188 31927 1139317 109417867
Sneezing 36.91 15.70 46 32069 31938 110525246
Pulmonary congestion 36.48 15.70 45 32070 30921 110526263
Toxicity to various agents 36.34 15.70 52 32063 480503 110076681
Dehiscence 36.20 15.70 12 32103 746 110556438
Sinus tachycardia 36.18 15.70 54 32061 44439 110512745
Depressed mood 36.10 15.70 64 32051 60745 110496439
Seasonal allergy 35.92 15.70 36 32079 19686 110537498
Arthralgia 35.08 15.70 113 32002 779519 109777665
Heat stroke 34.83 15.70 15 32100 1920 110555264
Apnoea 34.71 15.70 30 32085 13609 110543575
Nail dystrophy 34.11 15.70 13 32102 1215 110555969
Irritable bowel syndrome 33.80 15.70 4 32111 164211 110392973
Helicobacter infection 33.80 15.70 6 32109 181871 110375313
Respiratory rate increased 33.74 15.70 39 32076 25044 110532140
Blood pressure systolic increased 33.16 15.70 74 32041 82917 110474267
C-reactive protein increased 33.08 15.70 11 32104 217908 110339276
Adjustment disorder 32.15 15.70 26 32089 10769 110546415
Lung neoplasm 31.86 15.70 23 32092 8053 110549131
Angioplasty 31.33 15.70 14 32101 1957 110555227
Dyspnoea paroxysmal nocturnal 31.14 15.70 15 32100 2487 110554697
Blister 30.36 15.70 14 32101 227362 110329822
Drug dependence 30.15 15.70 53 32062 49967 110507217
Umbilical hernia 30.02 15.70 21 32094 7001 110550183
Increased bronchial secretion 29.99 15.70 17 32098 3931 110553253
Pancytopenia 29.42 15.70 12 32103 209601 110347583
Nasal inflammation 29.13 15.70 11 32104 1002 110556182
Bronchitis 29.07 15.70 106 32009 156926 110400258
Ankle fracture 28.67 15.70 32 32083 19787 110537397
Abdominal discomfort 28.42 15.70 44 32071 393814 110163370
Bradycardia 27.97 15.70 104 32011 155413 110401771
Intentional product misuse 27.95 15.70 3 32112 132901 110424283
Abscess 27.76 15.70 37 32078 27432 110529752
Axillary pain 27.71 15.70 14 32101 2572 110554612
Stomatitis 27.30 15.70 23 32092 270219 110286965
Acute pulmonary oedema 27.30 15.70 29 32086 16967 110540217
Drug hypersensitivity 27.15 15.70 57 32058 454033 110103151
Musculoskeletal stiffness 26.84 15.70 25 32090 279797 110277387
Pulmonary thrombosis 26.53 15.70 26 32089 13837 110543347
Aphonia 26.27 15.70 25 32090 12835 110544349
Restless legs syndrome 26.17 15.70 34 32081 24592 110532592
Neutropenia 25.94 15.70 43 32072 374577 110182607
Bronchospasm paradoxical 25.91 15.70 7 32108 214 110556970
Off label use 25.56 15.70 296 31819 1499889 109057295
Sputum purulent 25.52 15.70 12 32103 1886 110555298
Body temperature abnormal 25.28 15.70 14 32101 3095 110554089
Osteoarthritis 24.76 15.70 11 32104 182612 110374572
Dyspnoea at rest 24.64 15.70 20 32095 8326 110548858
Vulvovaginal candidiasis 24.56 15.70 14 32101 3271 110553913
Mydriasis 24.19 15.70 31 32084 22126 110535058
Dysphonia 24.17 15.70 62 32053 75867 110481317
Inflammation 24.13 15.70 13 32102 193225 110363959
Accelerated idioventricular rhythm 23.98 15.70 7 32108 285 110556899
Brachial plexopathy 23.66 15.70 7 32108 299 110556885
Dyslipidaemia 23.47 15.70 26 32089 15939 110541245
Dystonia 23.42 15.70 33 32082 25772 110531412
Saliva altered 23.36 15.70 8 32107 550 110556634
Flank pain 23.14 15.70 31 32084 23099 110534085
Precancerous condition 23.01 15.70 8 32107 575 110556609
Disease recurrence 22.94 15.70 53 32062 60731 110496453
Serotonin syndrome 22.79 15.70 52 32063 59101 110498083
Occupational exposure to air contaminants 22.78 15.70 6 32109 166 110557018
Hypoxia 22.77 15.70 86 32029 129429 110427755
Anaphylactic reaction 22.73 15.70 79 32036 114221 110442963
Bronchial obstruction 22.70 15.70 13 32102 3066 110554118
White blood cell count decreased 22.59 15.70 20 32095 229370 110327814
Haemoptysis 22.44 15.70 58 32057 71296 110485888
Infective exacerbation of chronic obstructive airways disease 22.27 15.70 13 32102 3177 110554007
Laryngitis fungal 22.19 15.70 6 32109 184 110557000
Cardiomyopathy 22.15 15.70 37 32078 33488 110523696
Liver injury 22.12 15.70 8 32107 150405 110406779
Ill-defined disorder 21.98 15.70 9 32106 156844 110400340
Liver disorder 21.90 15.70 7 32108 142236 110414948
Platelet count decreased 21.62 15.70 21 32094 230422 110326762
Adverse event 21.55 15.70 3 32112 108806 110448378
Maternal exposure during delivery 20.93 15.70 13 32102 3552 110553632
Blood test abnormal 20.88 15.70 33 32082 28521 110528663
Peripheral swelling 20.72 15.70 55 32060 403979 110153205
Choking sensation 20.69 15.70 14 32101 4422 110552762
Opisthotonus 20.68 15.70 8 32107 778 110556406
Decreased appetite 20.65 15.70 70 32045 475776 110081408
Sinus operation 20.38 15.70 12 32103 2979 110554205
Vasculitis 20.32 15.70 37 32078 35836 110521348
Urinary retention 20.25 15.70 55 32060 69628 110487556
Respiratory failure 20.15 15.70 119 31996 215213 110341971
Crepitations 20.14 15.70 20 32095 10815 110546369
Cerebral thrombosis 19.84 15.70 11 32104 2437 110554747
Pancreatic mass 19.75 15.70 10 32105 1845 110555339
Staphylococcal scalded skin syndrome 19.69 15.70 7 32108 538 110556646
Intentional overdose 19.56 15.70 7 32108 132494 110424690
Respiratory acidosis 19.44 15.70 22 32093 13804 110543380
Cardiorenal syndrome 19.44 15.70 10 32105 1908 110555276
Acute kidney injury 19.31 15.70 107 32008 635323 109921861
Drug abuse 19.30 15.70 14 32101 177397 110379787
Cerebrovascular accident 18.83 15.70 15 32100 181269 110375915
Proctitis bacterial 18.83 15.70 5 32110 143 110557041
Joint range of motion decreased 18.75 15.70 6 32109 121826 110435358
Hypotonia 18.73 15.70 23 32092 15722 110541462
Vital capacity decreased 18.70 15.70 10 32105 2063 110555121
Anaesthetic complication neurological 18.57 15.70 8 32107 1025 110556159
Physical deconditioning 18.53 15.70 12 32103 3525 110553659
Fatigue 18.38 15.70 246 31869 1215712 109341472
Staphylococcus test positive 18.33 15.70 16 32099 7354 110549830
Drug-induced liver injury 18.32 15.70 6 32109 120061 110437123
Peripheral vascular disorder 18.15 15.70 17 32098 8559 110548625
Fibromyalgia 17.93 15.70 14 32101 170895 110386289
Extrapyramidal disorder 17.93 15.70 31 32084 28836 110528348
Diplegia 17.81 15.70 10 32105 2271 110554913
Muscle disorder 17.64 15.70 15 32100 6657 110550527
Sleep disorder 17.61 15.70 19 32096 198625 110358559
Carboxyhaemoglobin increased 17.38 15.70 4 32111 62 110557122
Catheter site haemorrhage 17.17 15.70 14 32101 5866 110551318
Upper airway obstruction 17.13 15.70 9 32106 1793 110555391
Drug ineffective 16.55 15.70 327 31788 1520213 109036971
Brain injury 16.54 15.70 20 32095 13456 110543728
Respiratory symptom 16.45 15.70 21 32094 14924 110542260
Anticholinergic syndrome 16.45 15.70 12 32103 4268 110552916
Cellulitis 16.44 15.70 8 32107 126008 110431176
Granulomatosis with polyangiitis 16.24 15.70 11 32104 3479 110553705
Emphysema 16.09 15.70 24 32091 19732 110537452
Suicide attempt 16.07 15.70 5 32110 103389 110453795
Blood cholesterol increased 16.02 15.70 18 32097 184767 110372417
Pain in extremity 15.92 15.70 80 32035 487038 110070146
Abdominal pain 15.78 15.70 86 32029 512903 110044281
Pulmonary mass 15.73 15.70 34 32081 37267 110519917

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A03AB02 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
Synthetic anticholinergics, quaternary ammonium compounds
ATC A03CA05 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
ANTISPASMODICS IN COMBINATION WITH PSYCHOLEPTICS
Synthetic anticholinergic agents in combination with psycholeptics
ATC D11AA01 DERMATOLOGICALS
OTHER DERMATOLOGICAL PREPARATIONS
OTHER DERMATOLOGICAL PREPARATIONS
Antihidrotics
ATC R03AL04 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03AL07 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03AL09 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03AL11 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03AL12 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03BB06 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
Anticholinergics
FDA MoA N0000000125 Cholinergic Muscarinic Antagonists
FDA MoA N0000175370 Cholinergic Antagonists
FDA EPC N0000175574 Anticholinergic
MeSH PA D000759 Adjuvants, Anesthesia
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018678 Cholinergic Agents
MeSH PA D018680 Cholinergic Antagonists
MeSH PA D018727 Muscarinic Antagonists
FDA EPC N0000175700 Cholinergic Muscarinic Antagonist
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:231911 renoprotective agent
CHEBI has role CHEBI:22587 antiviral agent

Related Drugs by ATC class:

A03AB Synthetic anticholinergics, quaternary ammonium compounds 19 drugs
(2-benzhydryloxyethyl)diethyl-methylammonium iodidebenziloniumbevoniumdiphemanilfenpiveriniumhexocycliumisopropamidemepenzolatemethantheliniumotilonium bromideoxyphenoniumpenthienate show all 19 →
A03CA Synthetic anticholinergic agents in combination with psycholeptics 10 drugs
ambutoniumbevoniumclidiniumdiphemanilemeproniumisopropamideotilonium bromideoxyphencycliminepipenzolatepropantheline
D11AA Antihidrotics 1 drug
sofpironium bromide
R03AL Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids 14 drugs
aclidinium bromidebeclometasone dipropionatebudesonidefenoterolfluticasone furoateformoterolindacaterolipratropiummometasone furoateolodaterolsalbutamoltiotropium bromide show all 14 →
R03BB Anticholinergics 6 drugs
aclidinium bromideipratropiumoxitropiumrevefenacintiotropium bromideumeclidinium

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

DiseaseRelationSNOMED_IDDOID
Peptic ulcer indication 13200003 DOID:750
Chronic obstructive lung disease indication 13645005 DOID:3083
General anesthesia indication 50697003
Excessive salivation indication 53827007
Hyperhidrosis of axilla indication 303089000
Vagal Reflex Bradycardia indication
Irritable bowel syndrome off-label use 10743008 DOID:9778
Diarrhea off-label use 62315008
Brain damage contraindication 2470005
Tachyarrhythmia contraindication 6285003
Suicidal thoughts contraindication 6471006
Urinary tract obstruction contraindication 7163005 DOID:5200
Alcoholism contraindication 7200002
Hyperammonemia contraindication 9360008
Hepatic encephalopathy contraindication 13920009 DOID:13413
Severe chronic ulcerative colitis contraindication 14311001
Toxic megacolon contraindication 28536002 DOID:1770
Atony of colon contraindication 29479008
Hyperthyroidism contraindication 34486009 DOID:7998
Depressive disorder contraindication 35489007
Hypertensive disorder contraindication 38341003 DOID:10763
Complete trisomy 21 syndrome contraindication 41040004 DOID:14250
Achalasia of esophagus contraindication 45564002 DOID:9164
Chronic heart failure contraindication 48447003
Paralytic ileus contraindication 55525008 DOID:8442
Peptic reflux disease contraindication 57643001
Hepatic failure contraindication 59927004
Ulcerative colitis contraindication 64766004 DOID:8577
Poisoning by phenobarbital contraindication 64921004
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Hepatic coma contraindication 72836002 DOID:12550
Sleep apnea contraindication 73430006 DOID:0050847
Spastic paralysis contraindication 78403003
Disturbance of salivary secretion contraindication 78948009
Hiatal hernia contraindication 84089009 DOID:12642
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Gastrointestinal obstruction contraindication 126765001
Autonomic dysreflexia contraindication 129618003
Bleeding contraindication 131148009
Myocardial dysfunction contraindication 233928007
Disease of liver contraindication 235856003 DOID:409
Bladder outflow obstruction contraindication 236645006
Pyloric obstruction contraindication 244815007
Benign prostatic hyperplasia contraindication 266569009
Dyspnea contraindication 267036007
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Drowsy contraindication 271782001
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Angle-closure glaucoma contraindication 392291006 DOID:13550
Gastric ulcer contraindication 397825006 DOID:10808
Breastfeeding (mother) contraindication 413712001
Chronic lung disease contraindication 413839001
Disorder of coronary artery contraindication 414024009
Porphyria contraindication 418470004




🐶 Veterinary Drug Use

SpeciesUseRelation
Cats Preanesthesia Indication
Dogs Preanesthesia Indication

🐶 Veterinary products

ProductApplicantIngredients
Robinul-V Injectable Zoetis Inc. 1
Glycopyrrolate Injectable, Robinul-V Cronus Pharma Specialities India Private Limited 1

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
25MCG/ML LONHALA MAGNAIR KIT SUMITOMO PHARMA AM N208437 Dec. 5, 2017 DISCN SOLUTION INHALATION 10940110 Feb. 26, 2029 LONG-TERM MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 10716753 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 8324266 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 8703806 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 8808713 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 9415009 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 9463161 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 10716753 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 8324266 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 8703806 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 8808713 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 9415009 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 9463161 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 10716753 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 8324266 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 8703806 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 8808713 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 9415009 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 9463161 May 28, 2030 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.086MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 10159645 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
0.086MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 11590074 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
0.086MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 12357568 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
0.172MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 10159645 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
0.172MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 11590074 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
0.172MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 12357568 Dec. 23, 2030 MAINTENANCE TREATMENT OF ASTHMA
0.0048MG/INH;0.0090MG/INH BEVESPI AEROSPHERE ASTRAZENECA N208294 April 25, 2016 RX AEROSOL, METERED INHALATION 8815258 March 17, 2031 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.009MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 July 23, 2020 RX AEROSOL, METERED INHALATION 8815258 March 17, 2031 USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION 8815258 March 17, 2031 USE FOR THE MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER
0.086MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 10617638 Dec. 23, 2034 MAINTENANCE TREATMENT OF ASTHMA
0.172MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION 10617638 Dec. 23, 2034 MAINTENANCE TREATMENT OF ASTHMA
25MCG/ML LONHALA MAGNAIR KIT SUMITOMO PHARMA AM N208437 Dec. 5, 2017 DISCN SOLUTION INHALATION 10744277 Dec. 7, 2036 A METHOD OF USING AN AEROSOL DELIVERY DEVICE TO AEROSOLIZE GLYCOPYRROLATE FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.16MG/INH;0.0048MG/INH;0.018MG/INH BREZTRI AEROSPHERE ASTRAZENECA AB N212122 April 27, 2026 RX AEROSOL, METERED INHALATION April 27, 2029 NEW STRENGTH
0.086MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION May 14, 2029 NEW PRODUCT
0.172MG/INH;0.0049MG/INH;0.0106MG/INH TRIMBOW CHIESI N219622 May 14, 2026 RX AEROSOL, METERED INHALATION May 14, 2029 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Muscarinic acetylcholine receptor M1 GPCR ANTAGONIST Ki 9.69 SCIENTIFIC LITERATURE CHEMBL
Muscarinic acetylcholine receptor M2 GPCR ANTAGONIST Ki 9.25 SCIENTIFIC LITERATURE IUPHAR
Muscarinic acetylcholine receptor M3 GPCR ANTAGONIST Ki 9.64 SCIENTIFIC LITERATURE CHEMBL
Muscarinic acetylcholine receptor M4 GPCR ANTAGONIST Ki 9.06 SCIENTIFIC LITERATURE IUPHAR
Muscarinic acetylcholine receptor M5 GPCR ANTAGONIST Ki 8.91 SCIENTIFIC LITERATURE IUPHAR

External reference:

IDSource
4018421 VUID
N0000146747 NUI
D00540 KEGG_DRUG
51186-83-5 SECONDARY_CAS_RN
4018421 VANDF
4038210 VANDF
C4082411 UMLSCUI
CHEBI:5494 CHEBI
CHEMBL1201027 ChEMBL_ID
11693 PUBCHEM_CID
CHEMBL1201335 ChEMBL_ID
740028-90-4 SECONDARY_CAS_RN
DB00986 DRUGBANK_ID
1546438 RXNORM
4794 MMSL
609 MMSL
d00992 MMSL
001737 NDDF
017641 NDDF
387122008 SNOMEDCT_US
769097000 SNOMEDCT_US
772943003 SNOMEDCT_US
D006024 MESH_DESCRIPTOR_UI
CHEMBL3707243 ChEMBL_ID
7459 IUPHAR_LIGAND_ID
1038 INN_ID
V92SO9WP2I UNII
V92SO9WP2I INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-1250 TABLET 1 mg ORAL ANDA 12 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-1251 TABLET 2 mg ORAL ANDA 12 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9584 INJECTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9585 INJECTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9586 INJECTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9587 INJECTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9679 INJECTION 0.20 mg INTRAMUSCULAR ANDA 24 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9680 INJECTION 0.20 mg INTRAMUSCULAR ANDA 24 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9681 INJECTION 0.20 mg INTRAMUSCULAR ANDA 24 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9682 INJECTION 0.20 mg INTRAMUSCULAR ANDA 24 sections
Cuvposa HUMAN PRESCRIPTION DRUG LABEL 1 0259-0501 LIQUID 1 mg ORAL NDA 27 sections
BEVESPI AEROSPHERE HUMAN PRESCRIPTION DRUG LABEL 2 0310-4600 AEROSOL, METERED 9 ug RESPIRATORY (INHALATION) NDA 27 sections
BREZTRI HUMAN PRESCRIPTION DRUG LABEL 3 0310-4616 AEROSOL, METERED 9 ug RESPIRATORY (INHALATION) NDA 28 sections
BREZTRI HUMAN PRESCRIPTION DRUG LABEL 3 0310-6616 AEROSOL, METERED 18 ug RESPIRATORY (INHALATION) NDA 28 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9775 INJECTION, SOLUTION 0.20 mg INTRAMUSCULAR ANDA 12 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9776 INJECTION, SOLUTION 0.20 mg INTRAMUSCULAR ANDA 11 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9777 INJECTION, SOLUTION 0.20 mg INTRAMUSCULAR ANDA 11 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9782 INJECTION, SOLUTION 0.20 mg INTRAMUSCULAR ANDA 11 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9782 INJECTION, SOLUTION 0.20 mg INTRAMUSCULAR ANDA 11 sections
GLYCOPYRROLATE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9867 INJECTION 0.20 mg INTRAMUSCULAR ANDA 12 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0517-4601 INJECTION, SOLUTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0517-4602 INJECTION, SOLUTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0517-4605 INJECTION, SOLUTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0517-4620 INJECTION, SOLUTION 0.20 mg INTRAMUSCULAR ANDA 23 sections
GLYCOPYRROLATE HUMAN PRESCRIPTION DRUG LABEL 1 0615-8617 TABLET 1 mg ORAL ANDA 24 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6212 INJECTION 0.20 mg INTRAMUSCULAR NDA 22 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6212 INJECTION 0.20 mg INTRAMUSCULAR NDA 22 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6213 INJECTION 0.20 mg INTRAMUSCULAR NDA 22 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6213 INJECTION 0.20 mg INTRAMUSCULAR NDA 22 sections
Glycopyrrolate HUMAN PRESCRIPTION DRUG LABEL 1 0722-7097 TABLET 1.50 mg ORAL ANDA 16 sections