fluticasone furoate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4554 | 397864-44-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti‑inflammatory activity. Fluticasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor. The precise mechanism of corticosteroid action on asthma is not known. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. These anti-inflammatory actions of corticosteroids contribute to their efficacy in asthma.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.20 | mg | N |
| 0.11 | mg | N |
| 0.60 | mg | Inhal.aerosol |
| 0.60 | mg | Inhal.powder |
| 1.50 | mg | Inhal.solution |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 4.95 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 13.40 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 10.60 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 27, 2007 | FDA | GLAXOSMITHKLINE | |
| April 22, 2009 | PMDA | GlaxoSmithKline K.K. |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Macular degeneration | 460.12 | 18.99 | 161 | 12134 | 14227 | 50578602 |
| Asthma | 455.32 | 18.99 | 278 | 12017 | 89059 | 50503770 |
| Wheezing | 359.79 | 18.99 | 210 | 12085 | 61837 | 50530992 |
| Obstructive airways disorder | 337.13 | 18.99 | 131 | 12164 | 15521 | 50577308 |
| Full blood count abnormal | 198.60 | 18.99 | 102 | 12193 | 23286 | 50569543 |
| Nasal congestion | 171.94 | 18.99 | 123 | 12172 | 50997 | 50541832 |
| Dyspnoea | 134.54 | 18.99 | 361 | 11934 | 547247 | 50045582 |
| Therapeutic product effect incomplete | 115.24 | 18.99 | 126 | 12169 | 91389 | 50501440 |
| Bronchial haemorrhage | 112.65 | 18.99 | 26 | 12269 | 494 | 50592335 |
| Bronchial neoplasm | 111.90 | 18.99 | 25 | 12270 | 408 | 50592421 |
| Gastrooesophageal reflux disease | 102.82 | 18.99 | 109 | 12186 | 76319 | 50516510 |
| Nasal turbinate hypertrophy | 101.04 | 18.99 | 25 | 12270 | 645 | 50592184 |
| Cough | 99.98 | 18.99 | 196 | 12099 | 241068 | 50351761 |
| Sleep disorder due to a general medical condition | 95.54 | 18.99 | 43 | 12252 | 7328 | 50585501 |
| Chest discomfort | 95.35 | 18.99 | 115 | 12180 | 92607 | 50500222 |
| Endometrial ablation | 94.76 | 18.99 | 25 | 12270 | 838 | 50591991 |
| Productive cough | 94.67 | 18.99 | 88 | 12207 | 52606 | 50540223 |
| Bronchial disorder | 92.35 | 18.99 | 26 | 12269 | 1116 | 50591713 |
| Bronchiectasis | 87.67 | 18.99 | 45 | 12250 | 10238 | 50582591 |
| Nasal polyps | 83.14 | 18.99 | 29 | 12266 | 2525 | 50590304 |
| Blepharospasm | 82.80 | 18.99 | 30 | 12265 | 2918 | 50589911 |
| Hyper IgE syndrome | 79.81 | 18.99 | 19 | 12276 | 415 | 50592414 |
| Total lung capacity increased | 79.54 | 18.99 | 21 | 12274 | 706 | 50592123 |
| Rhonchi | 78.21 | 18.99 | 27 | 12268 | 2280 | 50590549 |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 78.10 | 18.99 | 19 | 12276 | 456 | 50592373 |
| Throat clearing | 77.82 | 18.99 | 23 | 12272 | 1175 | 50591654 |
| Respiratory tract inflammation | 75.68 | 18.99 | 19 | 12276 | 521 | 50592308 |
| Dust allergy | 74.93 | 18.99 | 19 | 12276 | 543 | 50592286 |
| Sputum discoloured | 71.31 | 18.99 | 43 | 12252 | 13352 | 50579477 |
| Blood immunoglobulin E increased | 69.99 | 18.99 | 25 | 12270 | 2334 | 50590495 |
| Malignant mediastinal neoplasm | 69.95 | 18.99 | 18 | 12277 | 546 | 50592283 |
| Dyspnoea exertional | 65.21 | 18.99 | 71 | 12224 | 51162 | 50541667 |
| Breath sounds abnormal | 63.26 | 18.99 | 33 | 12262 | 7759 | 50585070 |
| Restrictive pulmonary disease | 61.50 | 18.99 | 20 | 12275 | 1404 | 50591425 |
| Rhinitis | 61.29 | 18.99 | 33 | 12262 | 8268 | 50584561 |
| Taste disorder | 61.21 | 18.99 | 33 | 12262 | 8291 | 50584538 |
| Affective disorder | 60.15 | 18.99 | 28 | 12267 | 5153 | 50587676 |
| Blood test abnormal | 59.38 | 18.99 | 36 | 12259 | 11283 | 50581546 |
| Secretion discharge | 58.85 | 18.99 | 34 | 12261 | 9757 | 50583072 |
| Granuloma | 55.61 | 18.99 | 26 | 12269 | 4832 | 50587997 |
| Rhinorrhoea | 53.00 | 18.99 | 64 | 12231 | 51519 | 50541310 |
| Haemoptysis | 48.40 | 18.99 | 44 | 12251 | 25529 | 50567300 |
| Polycystic ovaries | 47.16 | 18.99 | 19 | 12276 | 2465 | 50590364 |
| Sleep apnoea syndrome | 47.01 | 18.99 | 42 | 12253 | 23826 | 50569003 |
| Chronic obstructive pulmonary disease | 46.46 | 18.99 | 61 | 12234 | 53374 | 50539455 |
| Sarcoidosis | 45.80 | 18.99 | 23 | 12272 | 4994 | 50587835 |
| Lung hyperinflation | 45.45 | 18.99 | 15 | 12280 | 1103 | 50591726 |
| Eczema | 44.82 | 18.99 | 40 | 12255 | 22662 | 50570167 |
| Nasal obstruction | 42.52 | 18.99 | 14 | 12281 | 1022 | 50591807 |
| Chronic sinusitis | 41.41 | 18.99 | 23 | 12272 | 6122 | 50586707 |
| Respiratory disorder | 41.03 | 18.99 | 44 | 12251 | 31143 | 50561686 |
| Rhinitis allergic | 40.62 | 18.99 | 24 | 12271 | 7176 | 50585653 |
| Lactose intolerance | 39.81 | 18.99 | 17 | 12278 | 2553 | 50590276 |
| Eye pruritus | 39.43 | 18.99 | 29 | 12266 | 12505 | 50580324 |
| Death | 37.66 | 18.99 | 16 | 12279 | 325363 | 50267466 |
| Toxicity to various agents | 37.49 | 18.99 | 4 | 12291 | 212495 | 50380334 |
| Sinusitis | 34.23 | 18.99 | 105 | 12190 | 170453 | 50422376 |
| Forced expiratory volume decreased | 33.93 | 18.99 | 18 | 12277 | 4376 | 50588453 |
| Dyslipidaemia | 33.89 | 18.99 | 20 | 12275 | 5968 | 50586861 |
| Herpes zoster | 33.51 | 18.99 | 61 | 12234 | 70725 | 50522104 |
| Ligament pain | 33.29 | 18.99 | 8 | 12287 | 182 | 50592647 |
| Rales | 31.19 | 18.99 | 23 | 12272 | 9955 | 50582874 |
| Weight decreased | 31.12 | 18.99 | 121 | 12174 | 221124 | 50371705 |
| Crystal arthropathy | 31.08 | 18.99 | 8 | 12287 | 243 | 50592586 |
| Migraine | 30.84 | 18.99 | 61 | 12234 | 75219 | 50517610 |
| Ear pruritus | 30.40 | 18.99 | 14 | 12281 | 2512 | 50590317 |
| Sneezing | 30.23 | 18.99 | 26 | 12269 | 14018 | 50578811 |
| Blood pressure diastolic abnormal | 30.22 | 18.99 | 22 | 12273 | 9339 | 50583490 |
| Epilepsy | 29.38 | 18.99 | 31 | 12264 | 21536 | 50571293 |
| Bronchitis | 28.68 | 18.99 | 72 | 12223 | 104087 | 50488742 |
| Alopecia | 26.84 | 18.99 | 13 | 12282 | 245034 | 50347795 |
| Asthmatic crisis | 25.98 | 18.99 | 11 | 12284 | 1617 | 50591212 |
| Ankle fracture | 25.81 | 18.99 | 25 | 12270 | 15697 | 50577132 |
| Swelling face | 25.74 | 18.99 | 46 | 12249 | 52549 | 50540280 |
| Blood pressure systolic increased | 25.58 | 18.99 | 37 | 12258 | 35412 | 50557417 |
| Sinus pain | 25.56 | 18.99 | 12 | 12283 | 2249 | 50590580 |
| Seasonal allergy | 25.34 | 18.99 | 24 | 12271 | 14652 | 50578177 |
| Angioedema | 25.28 | 18.99 | 38 | 12257 | 37638 | 50555191 |
| Blood pressure systolic abnormal | 24.62 | 18.99 | 18 | 12277 | 7688 | 50585141 |
| Pertussis | 23.71 | 18.99 | 8 | 12287 | 630 | 50592199 |
| Arthropathy | 23.22 | 18.99 | 5 | 12290 | 157901 | 50434928 |
| Blood pressure diastolic increased | 22.91 | 18.99 | 17 | 12278 | 7426 | 50585403 |
| Subclavian vein thrombosis | 21.74 | 18.99 | 10 | 12285 | 1789 | 50591040 |
| Sensitivity to weather change | 21.43 | 18.99 | 15 | 12280 | 5986 | 50586843 |
| Stress | 21.32 | 18.99 | 43 | 12252 | 53750 | 50539079 |
| Cardiac murmur | 21.27 | 18.99 | 19 | 12276 | 10765 | 50582064 |
| Sinus tachycardia | 21.11 | 18.99 | 26 | 12269 | 21328 | 50571501 |
| Stent placement | 20.82 | 18.99 | 12 | 12283 | 3426 | 50589403 |
| Lung neoplasm malignant | 20.63 | 18.99 | 22 | 12273 | 15462 | 50577367 |
| Eosinophilia | 20.55 | 18.99 | 24 | 12271 | 18628 | 50574201 |
| Paraesthesia | 20.45 | 18.99 | 70 | 12225 | 120173 | 50472656 |
| Eosinophil count increased | 20.34 | 18.99 | 17 | 12278 | 8813 | 50584016 |
| Radioallergosorbent test positive | 20.30 | 18.99 | 4 | 12291 | 34 | 50592795 |
| Dyspnoea at rest | 20.16 | 18.99 | 12 | 12283 | 3635 | 50589194 |
| Restless legs syndrome | 20.15 | 18.99 | 22 | 12273 | 15875 | 50576954 |
| Chondrocalcinosis pyrophosphate | 19.81 | 18.99 | 8 | 12287 | 1044 | 50591785 |
| Respiratory gas exchange disorder | 19.69 | 18.99 | 6 | 12289 | 340 | 50592489 |
| Oral pruritus | 19.26 | 18.99 | 9 | 12286 | 1669 | 50591160 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Asthma | 259.88 | 20.73 | 130 | 5897 | 33719 | 29534781 |
| Wheezing | 184.88 | 20.73 | 103 | 5924 | 33137 | 29535363 |
| Nasal polyps | 81.39 | 20.73 | 25 | 6002 | 1744 | 29566756 |
| Appendicolith | 79.39 | 20.73 | 29 | 5998 | 3451 | 29565049 |
| Therapeutic product effect incomplete | 73.13 | 20.73 | 62 | 5965 | 39243 | 29529257 |
| Sleep disorder due to a general medical condition | 70.96 | 20.73 | 26 | 6001 | 3120 | 29565380 |
| Obstructive airways disorder | 69.03 | 20.73 | 37 | 5990 | 10979 | 29557521 |
| Nasal congestion | 67.20 | 20.73 | 44 | 5983 | 18835 | 29549665 |
| Foetal malformation | 66.81 | 20.73 | 13 | 6014 | 125 | 29568375 |
| Trisomy 18 | 62.26 | 20.73 | 13 | 6014 | 183 | 29568317 |
| Appendicitis | 53.63 | 20.73 | 29 | 5998 | 8750 | 29559750 |
| Cough | 52.36 | 20.73 | 93 | 5934 | 126634 | 29441866 |
| Full blood count abnormal | 51.02 | 20.73 | 34 | 5993 | 14979 | 29553521 |
| Rhinitis | 50.74 | 20.73 | 23 | 6004 | 4755 | 29563745 |
| Sputum discoloured | 49.59 | 20.73 | 25 | 6002 | 6538 | 29561962 |
| Seasonal allergy | 46.22 | 20.73 | 22 | 6005 | 5080 | 29563420 |
| Ocular discomfort | 41.98 | 20.73 | 15 | 6012 | 1674 | 29566826 |
| Middle insomnia | 40.96 | 20.73 | 21 | 6006 | 5687 | 29562813 |
| Stress | 40.13 | 20.73 | 34 | 5993 | 21456 | 29547044 |
| Dyspnoea | 39.00 | 20.73 | 150 | 5877 | 326582 | 29241918 |
| Eye pruritus | 37.18 | 20.73 | 18 | 6009 | 4314 | 29564186 |
| Chest discomfort | 36.67 | 20.73 | 46 | 5981 | 45937 | 29522563 |
| Anosmia | 36.00 | 20.73 | 14 | 6013 | 1977 | 29566523 |
| Nasal oedema | 35.94 | 20.73 | 9 | 6018 | 293 | 29568207 |
| Forced expiratory volume decreased | 34.56 | 20.73 | 15 | 6012 | 2798 | 29565702 |
| Loss of personal independence in daily activities | 33.33 | 20.73 | 33 | 5994 | 25407 | 29543093 |
| Cardiogenic shock | 33.07 | 20.73 | 29 | 5998 | 19161 | 29549339 |
| Productive cough | 32.79 | 20.73 | 36 | 5991 | 31223 | 29537277 |
| Pharyngeal paraesthesia | 32.18 | 20.73 | 9 | 6018 | 451 | 29568049 |
| SARS-CoV-2 sepsis | 32.07 | 20.73 | 7 | 6020 | 123 | 29568377 |
| Glaucoma | 32.06 | 20.73 | 18 | 6009 | 5839 | 29562661 |
| Central obesity | 31.80 | 20.73 | 9 | 6018 | 471 | 29568029 |
| Victim of child abuse | 30.80 | 20.73 | 10 | 6017 | 835 | 29567665 |
| Eczema | 30.27 | 20.73 | 24 | 6003 | 13802 | 29554698 |
| Nasal disorder | 29.10 | 20.73 | 11 | 6016 | 1438 | 29567062 |
| Dermatitis atopic | 27.81 | 20.73 | 12 | 6015 | 2207 | 29566293 |
| Dermatitis allergic | 27.18 | 20.73 | 16 | 6011 | 5672 | 29562828 |
| Polyp | 26.70 | 20.73 | 13 | 6014 | 3152 | 29565348 |
| Nasal septum deviation | 25.67 | 20.73 | 9 | 6018 | 950 | 29567550 |
| Gastroenteritis eosinophilic | 25.22 | 20.73 | 6 | 6021 | 157 | 29568343 |
| Eosinophilic pneumonia chronic | 25.07 | 20.73 | 6 | 6021 | 161 | 29568339 |
| Ocular hyperaemia | 24.74 | 20.73 | 18 | 6009 | 9109 | 29559391 |
| Lung diffusion disorder | 23.23 | 20.73 | 5 | 6022 | 82 | 29568418 |
| Cortisol decreased | 23.02 | 20.73 | 8 | 6019 | 823 | 29567677 |
| Faecal calprotectin | 22.83 | 20.73 | 4 | 6023 | 20 | 29568480 |
| Alpha 2 globulin decreased | 22.83 | 20.73 | 4 | 6023 | 20 | 29568480 |
| Otosalpingitis | 22.83 | 20.73 | 4 | 6023 | 20 | 29568480 |
| Sex hormone binding globulin decreased | 22.67 | 20.73 | 4 | 6023 | 21 | 29568479 |
| Free androgen index decreased | 22.67 | 20.73 | 4 | 6023 | 21 | 29568479 |
| Androgen insensitivity syndrome | 22.51 | 20.73 | 4 | 6023 | 22 | 29568478 |
| Viral acanthoma | 22.51 | 20.73 | 4 | 6023 | 22 | 29568478 |
| Testicular microlithiasis | 22.22 | 20.73 | 4 | 6023 | 24 | 29568476 |
| Conjunctivitis | 22.19 | 20.73 | 16 | 6011 | 7982 | 29560518 |
| Dehydroepiandrosterone decreased | 22.08 | 20.73 | 4 | 6023 | 25 | 29568475 |
| Urine calcium/creatinine ratio increased | 22.08 | 20.73 | 4 | 6023 | 25 | 29568475 |
| Blood test abnormal | 21.92 | 20.73 | 14 | 6013 | 5735 | 29562765 |
| Ventricular fibrillation | 21.59 | 20.73 | 21 | 6006 | 15812 | 29552688 |
| Rhinorrhoea | 21.21 | 20.73 | 24 | 6003 | 21495 | 29547005 |
| Creatinine urine decreased | 20.79 | 20.73 | 4 | 6023 | 36 | 29568464 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Asthma | 580.85 | 16.97 | 339 | 16168 | 94886 | 64387339 |
| Wheezing | 486.20 | 16.97 | 285 | 16222 | 80294 | 64401931 |
| Obstructive airways disorder | 357.34 | 16.97 | 155 | 16352 | 23030 | 64459195 |
| Full blood count abnormal | 241.25 | 16.97 | 128 | 16379 | 29629 | 64452596 |
| Nasal congestion | 229.46 | 16.97 | 159 | 16348 | 59499 | 64422726 |
| Therapeutic product effect incomplete | 162.09 | 16.97 | 164 | 16343 | 103318 | 64378907 |
| Nasal polyps | 150.30 | 16.97 | 50 | 16457 | 3579 | 64478646 |
| Dyspnoea | 144.23 | 16.97 | 456 | 16051 | 718218 | 63764007 |
| Cough | 138.56 | 16.97 | 264 | 16243 | 301884 | 64180341 |
| Sleep disorder due to a general medical condition | 133.16 | 16.97 | 57 | 16450 | 8177 | 64474048 |
| Chest discomfort | 114.96 | 16.97 | 145 | 16362 | 115961 | 64366264 |
| Productive cough | 112.69 | 16.97 | 115 | 16392 | 73088 | 64409137 |
| Bronchial neoplasm | 110.03 | 16.97 | 25 | 16482 | 418 | 64481807 |
| Nasal turbinate hypertrophy | 108.70 | 16.97 | 26 | 16481 | 549 | 64481676 |
| Sputum discoloured | 106.96 | 16.97 | 63 | 16444 | 17793 | 64464432 |
| Rhinitis | 106.55 | 16.97 | 53 | 16454 | 10712 | 64471513 |
| Gastrooesophageal reflux disease | 100.58 | 16.97 | 115 | 16392 | 83028 | 64399197 |
| Endometrial ablation | 95.31 | 16.97 | 25 | 16482 | 776 | 64481449 |
| Rhonchi | 90.92 | 16.97 | 34 | 16473 | 3429 | 64478796 |
| Bronchial haemorrhage | 89.27 | 16.97 | 26 | 16481 | 1196 | 64481029 |
| Bronchiectasis | 87.62 | 16.97 | 51 | 16456 | 14089 | 64468136 |
| Throat clearing | 86.94 | 16.97 | 26 | 16481 | 1312 | 64480913 |
| Blood test abnormal | 81.04 | 16.97 | 47 | 16460 | 12896 | 64469329 |
| Hyper IgE syndrome | 76.34 | 16.97 | 19 | 16488 | 476 | 64481749 |
| Bronchial disorder | 75.23 | 16.97 | 26 | 16481 | 2089 | 64480136 |
| Total lung capacity increased | 74.27 | 16.97 | 20 | 16487 | 688 | 64481537 |
| Eczema | 71.61 | 16.97 | 60 | 16447 | 29660 | 64452565 |
| Blepharospasm | 70.29 | 16.97 | 28 | 16479 | 3347 | 64478878 |
| Appendicolith | 69.54 | 16.97 | 28 | 16479 | 3441 | 64478784 |
| Rhinorrhoea | 69.22 | 16.97 | 81 | 16426 | 59888 | 64422337 |
| Eye pruritus | 68.90 | 16.97 | 42 | 16465 | 12617 | 64469608 |
| Respiratory tract inflammation | 67.53 | 16.97 | 19 | 16488 | 771 | 64481454 |
| Restrictive pulmonary disease | 66.94 | 16.97 | 24 | 16483 | 2148 | 64480077 |
| Malignant mediastinal neoplasm | 65.14 | 16.97 | 17 | 16490 | 517 | 64481708 |
| Affective disorder | 63.94 | 16.97 | 32 | 16475 | 6548 | 64475677 |
| Blood immunoglobulin E increased | 63.43 | 16.97 | 27 | 16480 | 3817 | 64478408 |
| Toxicity to various agents | 63.23 | 16.97 | 9 | 16498 | 363504 | 64118721 |
| Forced expiratory volume decreased | 62.65 | 16.97 | 32 | 16475 | 6835 | 64475390 |
| Dust allergy | 62.14 | 16.97 | 19 | 16488 | 1034 | 64481191 |
| Breath sounds abnormal | 61.68 | 16.97 | 38 | 16469 | 11631 | 64470594 |
| Stress | 58.89 | 16.97 | 75 | 16432 | 60459 | 64421766 |
| Seasonal allergy | 54.01 | 16.97 | 35 | 16472 | 11691 | 64470534 |
| Secretion discharge | 53.36 | 16.97 | 35 | 16472 | 11929 | 64470296 |
| Taste disorder | 53.14 | 16.97 | 32 | 16475 | 9401 | 64472824 |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 52.63 | 16.97 | 17 | 16490 | 1108 | 64481117 |
| Sleep apnoea syndrome | 49.78 | 16.97 | 49 | 16458 | 29783 | 64452442 |
| Granuloma | 49.39 | 16.97 | 27 | 16480 | 6614 | 64475611 |
| Polycystic ovaries | 48.81 | 16.97 | 19 | 16488 | 2136 | 64480089 |
| Rhinitis allergic | 47.05 | 16.97 | 28 | 16479 | 8050 | 64474175 |
| Sinusitis | 46.33 | 16.97 | 110 | 16397 | 145818 | 64336407 |
| Respiratory disorder | 45.41 | 16.97 | 51 | 16456 | 36060 | 64446165 |
| Dyspnoea exertional | 44.72 | 16.97 | 73 | 16434 | 73657 | 64408568 |
| Middle insomnia | 44.06 | 16.97 | 32 | 16475 | 12845 | 64469380 |
| Lung hyperinflation | 42.95 | 16.97 | 16 | 16491 | 1596 | 64480629 |
| Lactose intolerance | 42.94 | 16.97 | 17 | 16490 | 1999 | 64480226 |
| Death | 39.79 | 16.97 | 39 | 16468 | 482666 | 63999559 |
| Migraine | 39.29 | 16.97 | 63 | 16444 | 62614 | 64419611 |
| Bronchitis | 38.96 | 16.97 | 86 | 16421 | 108657 | 64373568 |
| Chronic obstructive pulmonary disease | 38.64 | 16.97 | 67 | 16440 | 70981 | 64411244 |
| Anosmia | 38.60 | 16.97 | 20 | 16487 | 4397 | 64477828 |
| Nasal obstruction | 38.09 | 16.97 | 14 | 16493 | 1345 | 64480880 |
| Blood pressure diastolic increased | 37.43 | 16.97 | 27 | 16480 | 10725 | 64471500 |
| Chronic sinusitis | 37.15 | 16.97 | 22 | 16485 | 6270 | 64475955 |
| Loss of personal independence in daily activities | 36.40 | 16.97 | 66 | 16441 | 72388 | 64409837 |
| Lower respiratory tract infection | 36.38 | 16.97 | 77 | 16430 | 94537 | 64387688 |
| Polyp | 35.95 | 16.97 | 22 | 16485 | 6651 | 64475574 |
| Appendicitis | 33.94 | 16.97 | 28 | 16479 | 13541 | 64468684 |
| Swelling face | 33.75 | 16.97 | 57 | 16450 | 59109 | 64423116 |
| Herpes zoster | 33.45 | 16.97 | 67 | 16440 | 79120 | 64403105 |
| Sarcoidosis | 32.44 | 16.97 | 20 | 16487 | 6126 | 64476099 |
| Ligament pain | 32.35 | 16.97 | 8 | 16499 | 195 | 64482030 |
| Eosinophilic pneumonia chronic | 32.21 | 16.97 | 9 | 16498 | 356 | 64481869 |
| Anaemia | 31.87 | 16.97 | 30 | 16477 | 378650 | 64103575 |
| Thrombocytopenia | 31.69 | 16.97 | 9 | 16498 | 223792 | 64258433 |
| Cardiac murmur | 31.32 | 16.97 | 25 | 16482 | 11538 | 64470687 |
| Blood pressure diastolic abnormal | 30.66 | 16.97 | 25 | 16482 | 11892 | 64470333 |
| Nasal oedema | 30.54 | 16.97 | 11 | 16496 | 997 | 64481228 |
| Haemoptysis | 30.33 | 16.97 | 49 | 16458 | 48999 | 64433226 |
| SARS-CoV-2 sepsis | 30.32 | 16.97 | 7 | 16500 | 126 | 64482099 |
| Sneezing | 29.14 | 16.97 | 27 | 16480 | 15224 | 64467001 |
| Ear pruritus | 29.02 | 16.97 | 14 | 16493 | 2646 | 64479579 |
| Victim of child abuse | 28.26 | 16.97 | 10 | 16497 | 861 | 64481364 |
| Weight decreased | 28.23 | 16.97 | 146 | 16361 | 285593 | 64196632 |
| Ankle fracture | 28.02 | 16.97 | 26 | 16481 | 14684 | 64467541 |
| Acute kidney injury | 27.91 | 16.97 | 45 | 16462 | 449195 | 64033030 |
| Asthmatic crisis | 27.87 | 16.97 | 12 | 16495 | 1744 | 64480481 |
| Ocular discomfort | 26.30 | 16.97 | 15 | 16492 | 3984 | 64478241 |
| Oropharyngeal pain | 26.06 | 16.97 | 65 | 16442 | 88802 | 64393423 |
| Blood pressure systolic increased | 26.05 | 16.97 | 46 | 16461 | 49407 | 64432818 |
| Atopy | 25.55 | 16.97 | 7 | 16500 | 257 | 64481968 |
| Neutropenia | 25.27 | 16.97 | 15 | 16492 | 239609 | 64242616 |
| Dehydration | 25.16 | 16.97 | 12 | 16495 | 216751 | 64265474 |
| Dyslipidaemia | 25.07 | 16.97 | 20 | 16487 | 9222 | 64473003 |
| Eosinophilia | 24.86 | 16.97 | 39 | 16468 | 38037 | 64444188 |
| Epilepsy | 24.23 | 16.97 | 36 | 16471 | 33495 | 64448730 |
| Cardiac arrest | 24.14 | 16.97 | 5 | 16502 | 154059 | 64328166 |
| Throat irritation | 23.46 | 16.97 | 35 | 16472 | 32676 | 64449549 |
| Crepitations | 23.35 | 16.97 | 18 | 16489 | 7897 | 64474328 |
| Haemoglobin decreased | 22.33 | 16.97 | 11 | 16496 | 195052 | 64287173 |
| Nasal disorder | 22.21 | 16.97 | 12 | 16495 | 2872 | 64479353 |
| Cortisol decreased | 21.92 | 16.97 | 10 | 16497 | 1667 | 64480558 |
| Blood pressure systolic abnormal | 21.75 | 16.97 | 19 | 16488 | 9923 | 64472302 |
| Rales | 21.74 | 16.97 | 23 | 16484 | 15206 | 64467019 |
| Gastroenteritis eosinophilic | 21.70 | 16.97 | 6 | 16501 | 228 | 64481997 |
| Platelet count decreased | 21.52 | 16.97 | 8 | 16499 | 167703 | 64314522 |
| Lung neoplasm malignant | 21.52 | 16.97 | 27 | 16480 | 21421 | 64460804 |
| Sensitivity to weather change | 21.43 | 16.97 | 16 | 16491 | 6698 | 64475527 |
| Eosinophil count increased | 21.37 | 16.97 | 22 | 16485 | 14090 | 64468135 |
| Pertussis | 21.33 | 16.97 | 8 | 16499 | 813 | 64481412 |
| Paraesthesia | 21.10 | 16.97 | 79 | 16428 | 134443 | 64347782 |
| Pharyngeal paraesthesia | 20.64 | 16.97 | 10 | 16497 | 1907 | 64480318 |
| Sinus pain | 20.57 | 16.97 | 11 | 16496 | 2578 | 64479647 |
| Lung diffusion disorder | 20.45 | 16.97 | 5 | 16502 | 116 | 64482109 |
| Autism spectrum disorder | 20.27 | 16.97 | 8 | 16499 | 933 | 64481292 |
| Radioallergosorbent test positive | 20.19 | 16.97 | 4 | 16503 | 33 | 64482192 |
| Central obesity | 20.04 | 16.97 | 9 | 16498 | 1446 | 64480779 |
| Influenza | 19.66 | 16.97 | 66 | 16441 | 106465 | 64375760 |
| Eosinophilic granulomatosis with polyangiitis | 19.47 | 16.97 | 11 | 16496 | 2871 | 64479354 |
| Gastrointestinal haemorrhage | 19.32 | 16.97 | 5 | 16502 | 132307 | 64349918 |
| Cardiac failure congestive | 18.95 | 16.97 | 5 | 16502 | 130575 | 64351650 |
| Eosinophilic bronchitis | 18.91 | 16.97 | 6 | 16501 | 369 | 64481856 |
| Ocular hyperaemia | 18.91 | 16.97 | 26 | 16481 | 22538 | 64459687 |
| Respiratory failure | 18.58 | 16.97 | 9 | 16498 | 161174 | 64321051 |
| Overdose | 18.26 | 16.97 | 9 | 16498 | 159557 | 64322668 |
| Ovarian cyst | 18.19 | 16.97 | 18 | 16489 | 11000 | 64471225 |
| Oral pruritus | 18.19 | 16.97 | 9 | 16498 | 1796 | 64480429 |
| Sinus disorder | 18.11 | 16.97 | 22 | 16485 | 16886 | 64465339 |
| Febrile neutropenia | 18.08 | 16.97 | 13 | 16494 | 187644 | 64294581 |
| Asthenia | 17.44 | 16.97 | 54 | 16453 | 427990 | 64054235 |
| Respiratory tract infection | 17.43 | 16.97 | 33 | 16474 | 37374 | 64444851 |
| Paraesthesia oral | 17.28 | 16.97 | 19 | 16488 | 13112 | 64469113 |
| Malignant neoplasm progression | 17.00 | 16.97 | 4 | 16503 | 112867 | 64369358 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | D07AC17 | DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, potent (group III) |
| ATC | R01AD08 | RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids |
| ATC | R01AD12 | RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids |
| ATC | R01AD58 | RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids |
| ATC | R03AK06 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics |
| ATC | R03AK10 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics |
| ATC | R03AK11 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics |
| ATC | R03AL08 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids |
| ATC | R03BA05 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS Glucocorticoids |
| ATC | R03BA09 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS Glucocorticoids |
| FDA MoA | N0000175450 | Corticosteroid Hormone Receptor Agonists |
| FDA EPC | N0000175576 | Corticosteroid |
| CHEBI has role | CHEBI:49167 | anti-asthmatic drugs |
| CHEBI has role | CHEBI:50857 | anti-allergic drugs |
| MeSH PA | D018926 | Anti-Allergic Agents |
| MeSH PA | D018927 | Anti-Asthmatic Agents |
| MeSH PA | D000893 | Anti-Inflammatory Agents |
| MeSH PA | D001993 | Bronchodilator Agents |
| MeSH PA | D003879 | Dermatologic Agents |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| MeSH PA | D019141 | Respiratory System Agents |
| CHEBI has role | CHEBI:50266 | Prodrugs |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Chronic obstructive lung disease | indication | 13645005 | DOID:3083 |
| Allergic rhinitis | indication | 61582004 | |
| Chronic bronchitis | indication | 63480004 | DOID:6132 |
| Pulmonary emphysema | indication | 87433001 | |
| Asthma | indication | 195967001 | DOID:2841 |
| Chronic Non-Allergic Rhinitis | indication | ||
| Mycosis | contraindication | 3218000 | DOID:1564 |
| Ocular hypertension | contraindication | 4210003 | DOID:9282 |
| Epistaxis | contraindication | 12441001 | |
| Measles | contraindication | 14189004 | DOID:8622 |
| Disease caused by parasite | contraindication | 17322007 | |
| Glaucoma | contraindication | 23986001 | DOID:1686 |
| Viral disease | contraindication | 34014006 | DOID:934 |
| Hypercortisolism | contraindication | 47270006 | |
| Perforation of nasal septum | contraindication | 80142000 | |
| Bacterial infectious disease | contraindication | 87628006 | |
| Operation on nose | contraindication | 88733004 | |
| Bilateral cataracts | contraindication | 95722004 | |
| Pulmonary tuberculosis | contraindication | 154283005 | DOID:2957 |
| Ophthalmic herpes simplex | contraindication | 186542001 | |
| Varicella-zoster virus infection | contraindication | 309465005 | |
| Adrenal cortical hypofunction | contraindication | 386584007 | DOID:10493 |
| Exposure to varicella | contraindication | 444453009 | |
| Nasal Candidiasis | contraindication | ||
| Nasal Trauma | contraindication | ||
| Nasal Septal Ulcers | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 11.49 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | RE44874 | March 23, 2023 | FOR THE LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS |
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | RE44874 | March 23, 2023 | INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER |
| 0.2MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | April 30, 2015 | RX | POWDER | INHALATION | RE44874 | March 23, 2023 | INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER |
| 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | TRELEGY ELLIPTA | GLAXOSMITHKLINE | N209482 | Sept. 18, 2017 | RX | POWDER | INHALATION | RE44874 | March 23, 2023 | INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA |
| 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | TRELEGY ELLIPTA | GLAXOSMITHKLINE | N209482 | Sept. 18, 2017 | RX | POWDER | INHALATION | RE44874 | March 23, 2023 | INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA; AND ASTHMA |
| 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | TRELEGY ELLIPTA | GLAXOSMITHKLINE | N209482 | Sept. 9, 2020 | RX | POWDER | INHALATION | RE44874 | March 23, 2023 | INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA; AND ASTHMA |
| 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | TRELEGY ELLIPTA | GLAXOSMITHKLINE | N209482 | Sept. 18, 2017 | RX | POWDER | INHALATION | 8309572 | April 27, 2025 | METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION |
| 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | TRELEGY ELLIPTA | GLAXOSMITHKLINE | N209482 | Sept. 9, 2020 | RX | POWDER | INHALATION | 8309572 | April 27, 2025 | METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION |
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | 7439393 | May 21, 2025 | INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS |
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | 7439393 | May 21, 2025 | INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING BRONCHITIS AND/OR EMPHYSEMA |
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | 7439393 | May 21, 2025 | INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER |
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | 7439393 | May 21, 2025 | INDICATED FOR THE ONCE-DAILY TREATMENT OF ASTHMA IN PATIENTS 18 YEARS AND OLDER |
| 0.2MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | April 30, 2015 | RX | POWDER | INHALATION | 7439393 | May 21, 2025 | INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING BRONCHITIS AND/OR EMPHYSEMA |
| 0.2MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | April 30, 2015 | RX | POWDER | INHALATION | 7439393 | May 21, 2025 | INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER |
| 0.2MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | April 30, 2015 | RX | POWDER | INHALATION | 7439393 | May 21, 2025 | INDICATED FOR THE ONCE-DAILY TREATMENT OF ASTHMA IN PATIENTS 18 YEARS AND OLDER |
| 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | TRELEGY ELLIPTA | GLAXOSMITHKLINE | N209482 | Sept. 18, 2017 | RX | POWDER | INHALATION | 7439393 | May 21, 2025 | INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA |
| 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | TRELEGY ELLIPTA | GLAXOSMITHKLINE | N209482 | Sept. 18, 2017 | RX | POWDER | INHALATION | 7439393 | May 21, 2025 | MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 18 YRS AND OLDER, OR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA |
| 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | TRELEGY ELLIPTA | GLAXOSMITHKLINE | N209482 | Sept. 9, 2020 | RX | POWDER | INHALATION | 7439393 | May 21, 2025 | MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 18 YRS AND OLDER, OR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA |
| 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | TRELEGY ELLIPTA | GLAXOSMITHKLINE | N209482 | Sept. 18, 2017 | RX | POWDER | INHALATION | 8183257 | July 27, 2025 | METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA INHALATION |
| 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | TRELEGY ELLIPTA | GLAXOSMITHKLINE | N209482 | Sept. 18, 2017 | RX | POWDER | INHALATION | 8183257 | July 27, 2025 | METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION |
| 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | TRELEGY ELLIPTA | GLAXOSMITHKLINE | N209482 | Sept. 9, 2020 | RX | POWDER | INHALATION | 8183257 | July 27, 2025 | METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION |
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | 8511304 | June 14, 2027 | INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER |
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | 8511304 | June 14, 2027 | LONG-TERM, ONCE DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS |
| 0.2MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | April 30, 2015 | RX | POWDER | INHALATION | 8511304 | June 14, 2027 | INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER |
| 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | TRELEGY ELLIPTA | GLAXOSMITHKLINE | N209482 | Sept. 18, 2017 | RX | POWDER | INHALATION | 8511304 | June 14, 2027 | METHOD OF DISPENSING A COMBINATION MEDICAMENT PRODUCT FROM CLAIMED DELIVERY DEVICE, FOR EXAMPLE FOR THE TREATMENT OF ASTHMA OR COPD |
| 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | TRELEGY ELLIPTA | GLAXOSMITHKLINE | N209482 | Sept. 9, 2020 | RX | POWDER | INHALATION | 8511304 | June 14, 2027 | METHOD OF DISPENSING A COMBINATION MEDICAMENT PRODUCT FROM CLAIMED DELIVERY DEVICE, FOR EXAMPLE FOR THE TREATMENT OF ASTHMA OR COPD |
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | 11116721 | Feb. 26, 2029 | INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS |
| 0.1MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | May 10, 2013 | RX | POWDER | INHALATION | 11116721 | Feb. 26, 2029 | INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER |
| 0.2MG/INH;EQ 0.025MG BASE/INH | BREO ELLIPTA | GLAXO GRP LTD | N204275 | April 30, 2015 | RX | POWDER | INHALATION | 11116721 | Feb. 26, 2029 | INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER |
| 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | TRELEGY ELLIPTA | GLAXOSMITHKLINE | N209482 | Sept. 18, 2017 | RX | POWDER | INHALATION | 11090294 | Nov. 29, 2030 | MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) COMPRISING THE ONCE PER DAY ADMINISTRATION OF TRELEGY ELLIPTA, 100 MCG FLUTICASONE FUROATE/62.5 MCG UMECLIDINIUM/25 MCG VILANTEROL |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | TRELEGY ELLIPTA | GLAXOSMITHKLINE | N209482 | Sept. 18, 2017 | RX | POWDER | INHALATION | Sept. 9, 2023 | MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 18 YEARS AND OLDER |
| 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | TRELEGY ELLIPTA | GLAXOSMITHKLINE | N209482 | Sept. 9, 2020 | RX | POWDER | INHALATION | Sept. 9, 2023 | NEW STRENGTH |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Glucocorticoid receptor | Nuclear hormone receptor | AGONIST | IC50 | 10.12 | CHEMBL | CHEMBL | |||
| Mineralocorticoid receptor | Nuclear hormone receptor | IC50 | 6.83 | CHEMBL | |||||
| Progesterone receptor | Nuclear hormone receptor | IC50 | 7.68 | CHEMBL | |||||
| Androgen receptor | Transcription factor | IC50 | 5.73 | CHEMBL | |||||
| Glucocorticoid receptor | Transcription factor | IC50 | 8.30 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D06315 | KEGG_DRUG |
| 4026165 | VUID |
| N0000179800 | NUI |
| 4020529 | VANDF |
| 4026165 | VANDF |
| CHEBI:74899 | CHEBI |
| CHEBI:5134 | CHEBI |
| GW6 | PDB_CHEM_ID |
| CHEMBL1676 | ChEMBL_ID |
| C523187 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10892 | IUPHAR_LIGAND_ID |
| 6699 | IUPHAR_LIGAND_ID |
| 8521 | INN_ID |
| 90566-53-3 | SECONDARY_CAS_RN |
| DB08906 | DRUGBANK_ID |
| JS86977WNV | UNII |
| 9854489 | PUBCHEM_CID |
| 5311101 | PUBCHEM_CID |
| DB13867 | DRUGBANK_ID |
| 41126 | RXNORM |
| 109674 | MMSL |
| 23848 | MMSL |
| 51966 | MMSL |
| d01296 | MMSL |
| 004952 | NDDF |
| 012173 | NDDF |
| 108632003 | SNOMEDCT_US |
| 397192001 | SNOMEDCT_US |
| 426409006 | SNOMEDCT_US |
| C1948374 | UMLSCUI |
| C0082607 | UMLSCUI |
| CHEMBL1201396 | ChEMBL_ID |
| 5636 | INN_ID |
| D000068298 | MESH_DESCRIPTOR_UI |
| CUT2W21N7U | UNII |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| FLONASE SENSIMISTALLERGY RELIEF | HUMAN OTC DRUG LABEL | 1 | 0135-0615 | SPRAY, METERED | 27.50 ug | NASAL | NDA | 16 sections |
| FLONASE SENSIMISTALLERGY RELIEF | HUMAN OTC DRUG LABEL | 1 | 0135-0616 | SPRAY, METERED | 27.50 ug | NASAL | NDA | 16 sections |
| Breo Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0173-0859 | POWDER | 100 ug | RESPIRATORY (INHALATION) | NDA | 26 sections |
| Breo Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0173-0859 | POWDER | 100 ug | RESPIRATORY (INHALATION) | NDA | 26 sections |
| Arnuity Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0173-0874 | POWDER | 100 ug | RESPIRATORY (INHALATION) | NDA | 27 sections |
| Arnuity Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0173-0876 | POWDER | 200 ug | RESPIRATORY (INHALATION) | NDA | 27 sections |
| Breo Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0173-0882 | POWDER | 200 ug | RESPIRATORY (INHALATION) | NDA | 26 sections |
| Breo Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0173-0882 | POWDER | 200 ug | RESPIRATORY (INHALATION) | NDA | 26 sections |
| Trelegy Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0173-0887 | POWDER | 100 ug | RESPIRATORY (INHALATION) | NDA | 27 sections |
| Trelegy Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0173-0887 | POWDER | 100 ug | RESPIRATORY (INHALATION) | NDA | 27 sections |
| Arnuity Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0173-0888 | POWDER | 50 ug | RESPIRATORY (INHALATION) | NDA | 27 sections |
| Trelegy Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0173-0893 | POWDER | 200 ug | RESPIRATORY (INHALATION) | NDA | 27 sections |
| Trelegy Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0173-0893 | POWDER | 200 ug | RESPIRATORY (INHALATION) | NDA | 27 sections |
| FLONASE SENSIMISTALLERGY RELIEF | HUMAN OTC DRUG LABEL | 1 | 50090-5967 | SPRAY, METERED | 27.50 ug | NASAL | NDA | 17 sections |
| Veramyst | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-6168 | SPRAY, METERED | 27.50 ug | NASAL | NDA | 27 sections |
| Fluticasone Furoate and Vilanterol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 66993-135 | POWDER | 100 ug | RESPIRATORY (INHALATION) | NDA authorized generic | 26 sections |
| Fluticasone Furoate and Vilanterol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 66993-136 | POWDER | 200 ug | RESPIRATORY (INHALATION) | NDA authorized generic | 26 sections |
| Breo Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 2 | 70518-2028 | POWDER | 100 ug | RESPIRATORY (INHALATION) | NDA | 27 sections |
| Breo Ellipta | HUMAN PRESCRIPTION DRUG LABEL | 2 | 70518-2028 | POWDER | 100 ug | RESPIRATORY (INHALATION) | NDA | 27 sections |