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

Stem definitionDrug idCAS RN
prednisone and prednisolone derivatives 294 5534-09-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • rhinocort
  • beclometasone dipropionate
  • beclomethasone dipropionate
  • beclomethasone dipropionate monohydrate
An anti-inflammatory, synthetic glucocorticoid. It is used topically as an anti-inflammatory agent and in aerosol form for the treatment of ASTHMA.
  • Molecular weight: 521.05
  • Formula: C28H37ClO7
  • CLOGP: 4.26
  • LIPINSKI: 1
  • HAC: 7
  • HDO: 1
  • TPSA: 106.97
  • ALOGS: -5.40
  • ROTB: 8

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.40 mg N
0.80 mg Inhal.aerosol
0.80 mg Inhal.powder
1.50 mg Inhal.solution

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.05 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.29 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 36 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.13 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.50 hours Lombardo F, Berellini G, Obach RS
S (Water solubility) 0.00 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
May 12, 1976 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 433.20 12.69 382 25553 127179 63335908
Wheezing 208.75 12.69 225 25710 95370 63367717
Bacterial disease carrier 141.15 12.69 42 25893 1289 63461798
Bronchial secretion retention 129.27 12.69 47 25888 2726 63460361
Bronchospasm 128.73 12.69 83 25852 17197 63445890
Superinfection 113.44 12.69 42 25893 2565 63460522
Aggression 112.28 12.69 86 25849 23412 63439675
Dyspnoea 109.12 12.69 545 25390 660768 62802319
Nightmare 104.56 12.69 76 25859 19118 63443969
Drug ineffective 99.74 12.69 172 25763 1044593 62418494
Depressed mood 93.63 12.69 98 25837 40093 63422994
Sleep disorder due to a general medical condition 79.75 12.69 54 25881 12134 63450953
Chest discomfort 79.65 12.69 153 25782 109816 63353271
Cough 76.59 12.69 278 25657 292465 63170622
Swelling face 69.31 12.69 106 25829 63369 63399718
Nonspecific reaction 68.10 12.69 28 25907 2264 63460823
Lip swelling 67.49 12.69 73 25862 30990 63432097
Contraindicated product administered 66.87 12.69 6 25929 217642 63245445
Rheumatoid arthritis 63.85 12.69 13 25922 253806 63209281
Illness 62.33 12.69 88 25847 48971 63414116
Sinus operation 61.58 12.69 27 25908 2559 63460528
Scoliosis 61.49 12.69 39 25896 7849 63455238
Treatment failure 59.78 12.69 6 25929 199037 63264050
Arthropathy 59.11 12.69 12 25923 234780 63228307
Swollen tongue 57.47 12.69 71 25864 34729 63428358
Off label use 53.77 12.69 123 25812 674339 62788748
Infusion related reaction 53.26 12.69 17 25918 245504 63217583
Palpitations 51.07 12.69 130 25805 112640 63350447
Toxicity to various agents 47.14 12.69 21 25914 247229 63215858
Myalgia 46.90 12.69 149 25786 146380 63316707
Transient ischaemic attack 43.98 12.69 65 25870 37688 63425399
Asthmatic crisis 43.40 12.69 19 25916 1794 63461293
Separation anxiety disorder 43.35 12.69 8 25927 24 63463063
Glossodynia 43.26 12.69 10 25925 178866 63284221
Malaise 43.11 12.69 304 25631 415650 63047437
Anxiety 42.69 12.69 189 25746 217352 63245735
Atelectasis 42.37 12.69 48 25887 21435 63441652
Blood electrolytes abnormal 42.18 12.69 16 25919 1045 63462042
Pericarditis 42.14 12.69 3 25932 131576 63331511
Sputum discoloured 41.94 12.69 42 25893 16305 63446782
Death 41.87 12.69 55 25880 374326 63088761
Throat tightness 41.45 12.69 51 25884 24836 63438251
Rib fracture 38.76 12.69 47 25888 22550 63440537
Genital pain 38.31 12.69 12 25923 439 63462648
Systemic lupus erythematosus 37.89 12.69 19 25916 208899 63254188
Vascular device infection 37.66 12.69 28 25907 7284 63455803
Eosinophilia 36.88 12.69 46 25889 22710 63440377
Impaired quality of life 36.44 12.69 36 25899 13747 63449340
Abdominal discomfort 36.01 12.69 47 25888 320838 63142249
Hepatic enzyme increased 35.80 12.69 19 25916 202309 63260778
Flashback 34.39 12.69 9 25926 170 63462917
Squamous cell carcinoma of the oral cavity 33.76 12.69 10 25925 302 63462785
Middle insomnia 33.38 12.69 33 25902 12610 63450477
Infective pulmonary exacerbation of cystic fibrosis 33.04 12.69 28 25907 8789 63454298
Productive cough 33.01 12.69 77 25858 63131 63399956
Therapeutic product effect decreased 32.93 12.69 19 25916 193168 63269919
Limb injury 32.79 12.69 46 25889 25431 63437656
Periorbital swelling 32.06 12.69 18 25917 2900 63460187
Breast conserving surgery 31.79 12.69 13 25922 1036 63462051
Angioplasty 31.42 12.69 14 25921 1378 63461709
Oropharyngeal pain 31.05 12.69 97 25838 94390 63368697
Eosinophilic granulomatosis with polyangiitis 31.03 12.69 16 25919 2176 63460911
Alopecia 30.66 12.69 57 25878 337479 63125608
Bronchitis 30.36 12.69 116 25819 124819 63338268
Genital ulceration 30.15 12.69 11 25924 644 63462443
Miller Fisher syndrome 29.33 12.69 7 25928 89 63462998
Gastric mucosa erythema 29.33 12.69 9 25926 307 63462780
Abdominal rigidity 29.30 12.69 15 25920 2009 63461078
Discomfort 29.19 12.69 16 25919 167358 63295729
Anaphylactic reaction 28.67 12.69 75 25860 66025 63397062
Sinusitis 28.49 12.69 174 25761 226479 63236608
Sinus disorder 28.20 12.69 42 25893 24511 63438576
Hiccups 27.93 12.69 15 25920 2216 63460871
Musculoskeletal stiffness 27.63 12.69 21 25914 184597 63278490
Obstructive airways disorder 27.58 12.69 38 25897 20661 63442426
Helicobacter infection 27.32 12.69 3 25932 92782 63370305
Rhinovirus infection 27.11 12.69 19 25916 4510 63458577
Drug monitoring procedure not performed 27.05 12.69 10 25925 608 63462479
Peripheral vascular disorder 26.46 12.69 21 25914 6014 63457073
Arterial spasm 26.46 12.69 6 25929 60 63463027
Nail infection 26.20 12.69 15 25920 2508 63460579
Onychophagia 25.54 12.69 6 25929 71 63463016
Dizziness 25.51 12.69 278 25657 429647 63033440
Duodenal ulcer perforation 25.22 12.69 3 25932 87206 63375881
Dysmetropsia 25.02 12.69 6 25929 78 63463009
Essential tremor 24.74 12.69 11 25924 1077 63462010
Differential white blood cell count abnormal 24.71 12.69 10 25925 776 63462311
Choking 24.64 12.69 25 25910 9854 63453233
Crying 24.09 12.69 38 25897 23305 63439782
Paraesthesia oral 23.65 12.69 34 25901 19222 63443865
Forced expiratory volume decreased 23.32 12.69 18 25917 4950 63458137
Pharyngeal swelling 23.30 12.69 20 25915 6384 63456703
Hyponatraemia 23.27 12.69 99 25836 111801 63351286
Joint swelling 22.72 12.69 64 25871 327602 63135485
Rash macular 22.69 12.69 37 25898 23327 63439760
Eye movement disorder 22.51 12.69 18 25917 5210 63457877
Butterfly rash 22.42 12.69 12 25923 1761 63461326
Dermatitis allergic 21.99 12.69 29 25906 15119 63447968
Stomatitis 21.77 12.69 15 25920 138710 63324377
Anger 21.51 12.69 26 25909 12430 63450657
Food poisoning 21.06 12.69 16 25919 4300 63458787
Maternal exposure during pregnancy 21.01 12.69 36 25899 220026 63243061
Poor peripheral circulation 20.76 12.69 15 25920 3734 63459353
Secretion discharge 20.26 12.69 25 25910 12206 63450881
Pregnancy with implant contraceptive 20.25 12.69 13 25922 2670 63460417
Status asthmaticus 20.11 12.69 9 25926 895 63462192
Treatment noncompliance 20.06 12.69 46 25889 37279 63425808
Personality change 19.91 12.69 19 25916 6954 63456133
Idiopathic orbital inflammation 19.80 12.69 6 25929 196 63462891
Drug abuse 19.77 12.69 3 25932 72515 63390572
Mobility decreased 19.14 12.69 13 25922 121146 63341941
Lacrimation increased 19.13 12.69 32 25903 20599 63442488
Malignant neoplasm progression 19.04 12.69 5 25930 82116 63380971
Gastroenteritis aeromonas 18.79 12.69 4 25931 29 63463058
Gingival swelling 18.57 12.69 15 25920 4403 63458684
Mood altered 18.06 12.69 26 25909 14717 63448370
Blood cholesterol increased 17.88 12.69 8 25927 94024 63369063
Impaired healing 17.58 12.69 10 25925 102532 63360555
Tongue pruritus 17.45 12.69 7 25928 531 63462556
Hyperkinesia 17.35 12.69 10 25925 1694 63461393
Intentional product use issue 17.34 12.69 16 25919 127876 63335211
Oral mucosal blistering 17.09 12.69 16 25919 5717 63457370
Pubic pain 17.07 12.69 5 25930 145 63462942
Brain contusion 16.88 12.69 7 25928 578 63462509
Hallucination 16.84 12.69 55 25880 54762 63408325
Pulmonary congestion 16.13 12.69 27 25908 17391 63445696
Irritability 15.88 12.69 38 25897 31656 63431431
Nasal discomfort 15.58 12.69 14 25921 4746 63458341
Respiration abnormal 15.57 12.69 16 25919 6401 63456686
Acute myocardial infarction 15.54 12.69 38 25897 32086 63431001
Angioedema 15.53 12.69 49 25886 47916 63415171
Emotional disorder 15.52 12.69 23 25912 13356 63449731
Sleep terror 15.48 12.69 11 25924 2669 63460418
Platelet count decreased 15.19 12.69 15 25920 116107 63346980
Therapy non-responder 15.16 12.69 6 25929 75895 63387192
Antipsychotic drug level increased 15.16 12.69 12 25923 3423 63459664
Fungal infection 15.13 12.69 41 25894 36833 63426254
Tendonitis 15.05 12.69 28 25907 19587 63443500
Pulmonary oedema 15.04 12.69 53 25882 54820 63408267
Facial pain 15.00 12.69 20 25915 10541 63452546
Oral mucosa erosion 14.94 12.69 8 25927 1175 63461912
Heart rate increased 14.91 12.69 77 25858 94161 63368926
Psychomotor hyperactivity 14.85 12.69 20 25915 10643 63452444
Arthralgia 14.85 12.69 155 25780 569555 62893532
Derealisation 14.78 12.69 8 25927 1200 63461887
Reperfusion arrhythmia 14.68 12.69 5 25930 239 63462848
Bladder irritation 14.62 12.69 5 25930 242 63462845
Necrosis ischaemic 14.30 12.69 7 25928 853 63462234
Crepitations 14.24 12.69 17 25918 8023 63455064
Pneumonia streptococcal 14.23 12.69 9 25926 1802 63461285
Urticaria 14.19 12.69 116 25819 165686 63297401
Fall 14.18 12.69 232 25703 392102 63070985
Influenza 13.98 12.69 84 25851 108638 63354449
Therapeutic product effect incomplete 13.84 12.69 93 25842 124963 63338124
Product dosage form issue 13.83 12.69 3 25932 24 63463063
Cytomegalovirus enteritis 13.82 12.69 5 25930 286 63462801
Drug intolerance 13.80 12.69 72 25863 308589 63154498
Disease progression 13.72 12.69 18 25917 122740 63340347
Eosinophil count abnormal 13.55 12.69 6 25929 582 63462505
Urinary incontinence 13.54 12.69 36 25899 31978 63431109
Anaemia 13.37 12.69 68 25867 293362 63169725
Abnormal behaviour 13.32 12.69 28 25907 21398 63441689
Product use issue 13.20 12.69 46 25889 220474 63242613
Dermatitis atopic 13.18 12.69 18 25917 9706 63453381
Skin exfoliation 13.01 12.69 43 25892 43059 63420028
Gingival discomfort 12.82 12.69 5 25930 352 63462735
Migraine 12.75 12.69 79 25856 103267 63359820
Urinary retention 12.74 12.69 34 25901 30267 63432820

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 326.57 13.44 209 14249 42447 34900026
Wheezing 143.01 13.44 126 14332 41276 34901197
Dyspnoea 85.47 13.44 344 14114 376438 34566035
Nightmare 71.12 13.44 54 14404 14337 34928136
Anger 70.97 13.44 50 14408 11834 34930639
Lip swelling 63.73 13.44 53 14405 16027 34926446
Ballismus 54.95 13.44 12 14446 98 34942375
Sleep terror 51.06 13.44 23 14435 2295 34940178
Lower respiratory tract infection 49.19 13.44 63 14395 31574 34910899
Abnormal behaviour 49.07 13.44 56 14402 24913 34917560
Swollen tongue 47.48 13.44 43 14415 14562 34927911
Blood immunoglobulin E increased 45.94 13.44 22 14436 2524 34939949
Pharyngeal oedema 42.16 13.44 28 14430 6019 34936454
Infective pulmonary exacerbation of cystic fibrosis 39.18 13.44 28 14430 6773 34935700
Malaise 35.91 13.44 162 14296 185663 34756810
Nasal disorder 35.82 13.44 17 14441 1911 34940562
Attention-seeking behaviour 34.23 13.44 7 14451 40 34942433
Acquired macroglossia 32.44 13.44 6 14452 18 34942455
Cough 30.57 13.44 133 14325 150007 34792466
Neuropsychiatric symptoms 30.03 13.44 12 14446 890 34941583
Chest discomfort 29.67 13.44 68 14390 54462 34888011
Toxicity to various agents 29.25 13.44 24 14434 200338 34742135
Crepitations 27.75 13.44 17 14441 3179 34939294
Drug abuse 27.73 13.44 4 14454 99092 34843381
Chorea 27.35 13.44 12 14446 1125 34941348
Central obesity 26.97 13.44 10 14448 605 34941868
Dyspnoea at rest 24.95 13.44 17 14441 3811 34938662
Gastric ulcer perforation 24.81 13.44 11 14447 1057 34941416
Neonatal hyponatraemia 24.67 13.44 6 14452 82 34942391
Anosmia 24.18 13.44 17 14441 4007 34938466
Daydreaming 24.17 13.44 9 14449 551 34941922
Sputum discoloured 23.45 13.44 22 14436 7790 34934683
Nasal discomfort 23.24 13.44 12 14446 1616 34940857
Crying 22.55 13.44 19 14439 5843 34936630
Death 22.35 13.44 87 14371 397962 34544511
Depressed mood 21.82 13.44 33 14425 19284 34923189
Completed suicide 21.34 13.44 7 14451 98161 34844312
Paraesthesia oral 21.28 13.44 16 14442 4181 34938292
Neuropsychiatric syndrome 21.16 13.44 5 14453 60 34942413
Spleen congestion 21.02 13.44 7 14451 308 34942165
Gastrointestinal tract irritation 20.96 13.44 7 14451 311 34942162
Cervicogenic headache 20.94 13.44 4 14454 15 34942458
Micturition urgency 20.79 13.44 19 14439 6506 34935967
Tic 20.61 13.44 12 14446 2046 34940427
Platelet count decreased 20.56 13.44 12 14446 119705 34822768
Productive cough 20.39 13.44 47 14411 37766 34904707
Off label use 20.31 13.44 97 14361 419427 34523046
Mood altered 19.16 13.44 21 14437 8931 34933542
Mesothelioma 18.66 13.44 7 14451 438 34942035
Graft versus host disease in gastrointestinal tract 18.58 13.44 14 14444 3669 34938804
Suicidal ideation 18.36 13.44 47 14411 40341 34902132
Irritability 18.35 13.44 35 14423 24655 34917818
Chronic obstructive pulmonary disease 18.31 13.44 53 14405 48865 34893608
Locked-in syndrome 17.91 13.44 6 14452 269 34942204
Mood swings 17.72 13.44 19 14439 7882 34934591
Sinusitis 17.61 13.44 47 14411 41355 34901118
Bronchomalacia 17.53 13.44 5 14453 130 34942343
Nasal septum perforation 17.49 13.44 5 14453 131 34942342
Convulsive threshold lowered 17.37 13.44 7 14451 531 34941942
Self-injurious ideation 17.34 13.44 10 14448 1674 34940799
Eye swelling 17.28 13.44 21 14437 9974 34932499
Reading disorder 17.27 13.44 7 14451 539 34941934
Multifocal motor neuropathy 17.24 13.44 4 14454 44 34942429
Impaired quality of life 16.73 13.44 16 14442 5802 34936671
Oral pain 15.94 13.44 21 14437 10806 34931667
Thrombocytopenia 15.94 13.44 25 14433 156222 34786251
Disease progression 15.68 13.44 13 14445 108064 34834409
Palpitations 15.62 13.44 44 14414 39942 34902531
Pruritus 15.41 13.44 106 14352 141875 34800598
Apnoeic attack 15.35 13.44 6 14452 420 34942053
Benign prostatic hyperplasia 15.30 13.44 24 14434 14471 34928002
Headache 15.28 13.44 138 14320 200497 34741976
Renal failure 15.20 13.44 19 14439 130538 34811935
Antibody test abnormal 15.17 13.44 5 14453 213 34942260
Ocular discomfort 15.16 13.44 10 14448 2124 34940349
Infarction 15.09 13.44 11 14447 2742 34939731
Aortic dissection 15.04 13.44 11 14447 2757 34939716
Renal aplasia 14.99 13.44 7 14451 759 34941714
Tryptase increased 14.76 13.44 5 14453 232 34942241
Slow speech 14.73 13.44 8 14450 1194 34941279
Weaning failure 14.68 13.44 5 14453 236 34942237
Ejaculation failure 14.62 13.44 7 14451 802 34941671
Pharyngeal swelling 14.59 13.44 10 14448 2262 34940211
Eosinophilia 14.58 13.44 33 14425 26189 34916284
Angioedema 14.47 13.44 41 14417 37333 34905140
Neonatal seizure 14.37 13.44 6 14452 498 34941975
Testicular mass 14.17 13.44 4 14454 100 34942373
Nasal inflammation 14.03 13.44 5 14453 270 34942203
Urticaria 14.02 13.44 57 14401 62320 34880153
Violence-related symptom 14.01 13.44 6 14452 530 34941943
Abdominal symptom 13.96 13.44 6 14452 535 34941938
Sleep talking 13.95 13.44 6 14452 536 34941937
Rash papular 13.71 13.44 19 14439 10259 34932214
Hepatic cancer 13.68 13.44 17 14441 8258 34934215
Ageusia 13.66 13.44 19 14439 10289 34932184
Forced expiratory volume decreased 13.61 13.44 11 14447 3192 34939281
Obsessive-compulsive disorder 13.59 13.44 14 14444 5550 34936923
Malignant neoplasm progression 13.52 13.44 10 14448 88036 34854437
Sleep disorder 13.50 13.44 36 14422 31652 34910821

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 601.05 11.72 486 34292 134609 79575001
Wheezing 303.87 11.72 311 34467 116353 79593257
Nightmare 189.56 11.72 126 34652 25735 79683875
Dyspnoea 166.27 11.72 775 34003 856250 78853360
Bacterial disease carrier 136.38 11.72 43 34735 1503 79708107
Lip swelling 130.54 11.72 122 34656 40789 79668821
Depressed mood 122 11.72 127 34651 48353 79661257
Bronchospasm 111.41 11.72 90 34688 24769 79684841
Bronchial secretion retention 108.42 11.72 47 34731 4057 79705553
Swollen tongue 104.40 11.72 110 34668 42460 79667150
Drug ineffective 94.23 11.72 208 34570 1080705 78628905
Chest discomfort 88.81 11.72 190 34588 137854 79571756
Aggression 88.26 11.72 110 34668 50848 79658762
Superinfection 85.23 11.72 42 34736 4860 79704750
Completed suicide 84.03 11.72 6 34772 245761 79463849
Anger 80.88 11.72 64 34714 17098 79692512
Toxicity to various agents 77.21 11.72 44 34734 421496 79288114
Swelling face 74.73 11.72 121 34657 71091 79638519
Sinus operation 70.26 11.72 30 34748 2495 79707115
Malaise 70.15 11.72 408 34370 489461 79220149
Sleep disorder due to a general medical condition 68.91 11.72 54 34724 14223 79695387
Palpitations 67.75 11.72 162 34616 126448 79583162
Infective pulmonary exacerbation of cystic fibrosis 67.26 11.72 51 34727 12800 79696810
Cough 66.46 11.72 326 34452 366463 79343147
Off label use 65.43 11.72 192 34586 907023 78802587
Scoliosis 63.62 11.72 40 34738 7424 79702186
Abnormal behaviour 62.07 11.72 78 34700 36343 79673267
Sputum discoloured 62.07 11.72 61 34717 21682 79687928
Illness 61.49 11.72 88 34690 46423 79663187
Nonspecific reaction 60.42 11.72 27 34751 2505 79707105
Myalgia 58.44 11.72 196 34582 185445 79524165
Sleep terror 56.80 11.72 31 34747 4427 79705183
Death 55.13 11.72 102 34676 566412 79143198
Rheumatoid arthritis 52.72 11.72 13 34765 208457 79501153
Infusion related reaction 51.57 11.72 18 34760 230219 79479391
Treatment failure 50.88 11.72 7 34771 170479 79539131
Synovitis 50.60 11.72 4 34774 150730 79558880
Separation anxiety disorder 48.18 11.72 9 34769 27 79709583
Contraindicated product administered 48.13 11.72 6 34772 157532 79552078
Drug abuse 47.80 11.72 7 34771 162684 79546926
Anxiety 45.75 11.72 222 34556 248290 79461320
Pharyngeal oedema 45.24 11.72 45 34733 16227 79693383
Eosinophilia 44.80 11.72 75 34703 45270 79664340
Impaired quality of life 44.15 11.72 42 34736 14344 79695266
Crying 43.55 11.72 52 34726 22991 79686619
Ballismus 42.12 11.72 12 34766 294 79709316
Productive cough 40.90 11.72 107 34671 88224 79621386
Asthmatic crisis 40.36 11.72 19 34759 1987 79707623
Crepitations 40.15 11.72 34 34744 9983 79699627
Dizziness 39.88 11.72 377 34401 526064 79183546
Arthropathy 39.39 11.72 14 34764 177097 79532513
Transient ischaemic attack 39.13 11.72 77 34701 52618 79656992
Paraesthesia oral 38.36 11.72 46 34732 20425 79689185
Genital pain 37.80 11.72 14 34764 800 79708810
Irritability 36.64 11.72 65 34713 41079 79668531
Hepatic enzyme increased 36.44 11.72 17 34761 182593 79527017
Throat tightness 35.71 11.72 52 34726 27855 79681755
Mood altered 34.92 11.72 41 34737 17806 79691804
Breast conserving surgery 34.54 11.72 13 34765 777 79708833
Periorbital swelling 33.78 11.72 19 34759 2877 79706733
Pharyngeal swelling 32.59 11.72 27 34751 7692 79701918
Attention-seeking behaviour 32.56 11.72 8 34770 108 79709502
Obstructive airways disorder 32.37 11.72 53 34725 31406 79678204
Oropharyngeal pain 32.23 11.72 113 34665 109240 79600370
Eosinophilic granulomatosis with polyangiitis 32.16 11.72 20 34758 3640 79705970
Essential tremor 32.13 11.72 15 34763 1540 79708070
Blood electrolytes abnormal 31.93 11.72 16 34762 1918 79707692
Middle insomnia 31.58 11.72 37 34741 16032 79693578
Mood swings 31.39 11.72 41 34737 19839 79689771
Rib fracture 31.38 11.72 49 34729 27898 79681712
Choking 30.96 11.72 32 34746 12069 79697541
Genital ulceration 30.38 11.72 13 34765 1087 79708523
Forced expiratory volume decreased 30.25 11.72 26 34752 7788 79701822
Rash macular 30.16 11.72 49 34729 28850 79680760
Atelectasis 30.07 11.72 52 34726 32205 79677405
Malignant neoplasm progression 29.81 11.72 11 34767 135979 79573631
Angioplasty 29.55 11.72 15 34763 1848 79707762
Pericarditis 29.45 11.72 5 34773 104231 79605379
Thrombocytopenia 28.27 11.72 45 34733 265214 79444396
Angioedema 28.21 11.72 85 34693 75950 79633660
Platelet count decreased 28.18 11.72 26 34752 194638 79514972
Limb injury 28.05 11.72 48 34730 29480 79680130
Squamous cell carcinoma of the oral cavity 27.94 11.72 10 34768 518 79709092
Blood immunoglobulin E increased 27.85 11.72 22 34756 5860 79703750
Vascular device infection 27.79 11.72 28 34750 10248 79699362
Antipsychotic drug level increased 27.60 11.72 22 34756 5935 79703675
Dermatitis allergic 26.49 11.72 36 34742 18094 79691516
Nail infection 25.99 11.72 15 34763 2384 79707226
Gingival swelling 25.69 11.72 19 34759 4590 79705020
Hallucination 25.61 11.72 89 34689 85656 79623954
Disease progression 25.09 11.72 26 34752 184336 79525274
Anaphylactic reaction 25.07 11.72 87 34691 83656 79625954
Abdominal rigidity 24.95 11.72 16 34762 3072 79706538
Poor peripheral circulation 24.72 11.72 17 34761 3666 79705944
Pregnancy with implant contraceptive 23.90 11.72 13 34765 1843 79707767
Peripheral vascular disorder 23.80 11.72 23 34755 8007 79701603
Dysmetropsia 23.77 11.72 6 34772 91 79709519
Anaemia 23.48 11.72 107 34671 444908 79264702
Micturition urgency 23.02 11.72 28 34750 12613 79696997
Tic 22.96 11.72 15 34763 2971 79706639
Food poisoning 22.93 11.72 18 34760 4751 79704859
Urticaria 22.47 11.72 148 34630 185053 79524557
Psychomotor hyperactivity 22.44 11.72 32 34746 16817 79692793
Musculoskeletal stiffness 22.36 11.72 26 34752 174982 79534628
Bleeding time prolonged 22.34 11.72 11 34767 1270 79708340
Rhinovirus infection 22.12 11.72 22 34756 7931 79701679
Nasal disorder 22.06 11.72 16 34762 3753 79705857
Febrile neutropenia 22.05 11.72 42 34736 230957 79478653
Sinus disorder 21.98 11.72 37 34741 22427 79687183
Drug monitoring procedure not performed 21.66 11.72 10 34768 1001 79708609
Miller Fisher syndrome 21.61 11.72 7 34771 267 79709343
Intentional product use issue 21.21 11.72 21 34757 152091 79557519
Disturbance in attention 20.96 11.72 59 34719 50742 79658868
Flashback 20.90 11.72 7 34771 297 79709313
Arterial spasm 20.65 11.72 6 34772 158 79709452
Systemic lupus erythematosus 20.26 11.72 14 34764 121135 79588475
Anosmia 20.17 11.72 22 34756 8822 79700788
Somnambulism 20.07 11.72 18 34760 5703 79703907
Suicidal ideation 20.05 11.72 76 34702 76264 79633346
Glossodynia 20.03 11.72 10 34768 103327 79606283
Ejaculation failure 19.65 11.72 7 34771 358 79709252
Butterfly rash 19.44 11.72 11 34767 1685 79707925
Liver function test abnormal 19.31 11.72 67 34711 64408 79645202
Daydreaming 19.28 11.72 9 34769 924 79708686
Hyponatraemia 19.13 11.72 138 34640 177710 79531900
Central obesity 19.05 11.72 11 34767 1750 79707860
Upper gastrointestinal haemorrhage 19.02 11.72 50 34728 41330 79668280
Dermatitis bullous 18.89 11.72 27 34751 14218 79695392
Acquired macroglossia 18.78 11.72 6 34772 219 79709391
Renal failure 18.78 11.72 37 34741 200931 79508679
Emotional disorder 18.68 11.72 27 34751 14360 79695250
Gastroenteritis aeromonas 18.52 11.72 4 34774 29 79709581
Neuropsychiatric symptoms 18.47 11.72 10 34768 1405 79708205
Graft versus host disease in gastrointestinal tract 18.45 11.72 18 34760 6338 79703272
Oral pain 18.42 11.72 42 34736 31756 79677854
Helicobacter infection 18.30 11.72 4 34774 69700 79639910
Chorea 18.24 11.72 12 34766 2405 79707205
Therapeutic product effect decreased 18.21 11.72 27 34751 163836 79545774
Pulmonary congestion 18.21 11.72 38 34740 27062 79682548
Adverse drug reaction 18.19 11.72 67 34711 66325 79643285
Spleen congestion 18.16 11.72 7 34771 447 79709163
Idiopathic orbital inflammation 17.90 11.72 6 34772 255 79709355
Muscle spasms 17.89 11.72 134 34644 174596 79535014
Secretion discharge 17.79 11.72 27 34751 14995 79694615
Nasal discharge discolouration 17.78 11.72 12 34766 2509 79707101
Neuropsychiatric syndrome 17.69 11.72 5 34773 119 79709491
Cervicogenic headache 17.66 11.72 4 34774 37 79709573
Heart rate increased 17.48 11.72 101 34677 120623 79588987
Encephalopathy 17.42 11.72 4 34774 67393 79642217
Differential white blood cell count abnormal 17.37 11.72 11 34767 2066 79707544
Blood pressure fluctuation 17.33 11.72 4 34774 67141 79642469
Joint swelling 17.32 11.72 66 34712 288580 79421030
Multifocal motor neuropathy 17.03 11.72 4 34774 44 79709566
Pain 16.99 11.72 211 34567 703591 79006019
Syncope 16.91 11.72 135 34643 179314 79530296
Eye movement disorder 16.67 11.72 19 34759 7992 79701618
Product administered to patient of inappropriate age 16.63 11.72 16 34762 5537 79704073
Lactic acidosis 16.62 11.72 5 34773 70354 79639256
Tongue pruritus 16.61 11.72 7 34771 563 79709047
White blood cell count decreased 16.46 11.72 36 34742 188252 79521358
Bronchitis 16.20 11.72 105 34673 130539 79579071
Headache 16.20 11.72 386 34392 653386 79056224
Migraine 15.95 11.72 78 34700 87415 79622195
Reading disorder 15.70 11.72 8 34770 994 79708616
Pubic pain 15.61 11.72 5 34773 184 79709426
Stomatitis 15.52 11.72 25 34753 146732 79562878
Status asthmaticus 15.46 11.72 8 34770 1026 79708584
Skin exfoliation 15.42 11.72 56 34722 55044 79654566
Urinary incontinence 15.42 11.72 46 34732 40863 79668747
Treatment noncompliance 15.38 11.72 54 34724 52214 79657396
Gastrointestinal tract irritation 15.37 11.72 7 34771 679 79708931
Therapeutic product effect incomplete 15.28 11.72 110 34668 141535 79568075
Testicular mass 15.15 11.72 4 34774 73 79709537
Oral mucosal blistering 15.04 11.72 16 34762 6235 79703375
Impaired healing 14.83 11.72 10 34768 87645 79621965
Overdose 14.68 11.72 37 34741 184169 79525441
Gastric ulcer perforation 14.67 11.72 10 34768 2125 79707485
Infection 14.67 11.72 55 34723 241657 79467953
Suicide attempt 14.66 11.72 9 34769 82923 79626687
Personality change 14.56 11.72 20 34758 10150 79699460
Nasal congestion 14.50 11.72 69 34709 76483 79633127
Tendonitis 14.39 11.72 32 34746 23798 79685812
Eye swelling 14.28 11.72 34 34744 26434 79683176
Blood creatinine increased 14.09 11.72 29 34749 155028 79554582
Cardio-respiratory arrest 13.99 11.72 16 34762 108494 79601116
Benign prostatic hyperplasia 13.94 11.72 21 34757 11591 79698019
Bladder irritation 13.83 11.72 5 34773 267 79709343
Nasal septum ulceration 13.75 11.72 3 34775 23 79709587
Bronchomalacia 13.74 11.72 5 34773 272 79709338
Mouth swelling 13.71 11.72 15 34763 6036 79703574
Discomfort 13.66 11.72 21 34757 125596 79584014
Duodenal ulcer perforation 13.46 11.72 6 34772 66205 79643405
Intentional product misuse 13.42 11.72 13 34765 95152 79614458
Reperfusion arrhythmia 13.35 11.72 5 34773 295 79709315
Hypovolaemia 13.31 11.72 26 34752 17665 79691945
Skin fragility 13.27 11.72 7 34771 934 79708676
Convulsive threshold lowered 13.23 11.72 7 34771 940 79708670
Ageusia 13.19 11.72 25 34753 16607 79693003
Poor quality sleep 13.15 11.72 30 34748 22692 79686918
Growth retardation 13.11 11.72 9 34769 1934 79707676
Oral mucosa erosion 13.10 11.72 9 34769 1938 79707672
Dyspnoea at rest 13.02 11.72 16 34762 7286 79702324
Neutropenia 12.98 11.72 73 34705 287637 79421973
Pulmonary oedema 12.88 11.72 74 34704 88180 79621430
Fibromyalgia 12.81 11.72 6 34772 64334 79645276
Abdominal discomfort 12.78 11.72 61 34717 250666 79458944
Abnormal weight gain 12.76 11.72 10 34768 2634 79706976
Vaginal discharge 12.74 11.72 16 34762 7447 79702163
Sleep disorder 12.61 11.72 72 34706 85605 79624005
Beta haemolytic streptococcal infection 12.50 11.72 9 34769 2088 79707522
Mouth ulceration 12.47 11.72 41 34737 38353 79671257
Contusion 12.46 11.72 109 34669 148667 79560943
Pneumonia streptococcal 12.43 11.72 10 34768 2735 79706875
Platelet count increased 12.32 11.72 29 34749 22377 79687233
Necrosis ischaemic 12.30 11.72 7 34771 1083 79708527
Lacrimation increased 12.26 11.72 29 34749 22448 79687162
Sputum retention 12.26 11.72 7 34771 1090 79708520
Respiration abnormal 12.20 11.72 16 34762 7772 79701838
Gastric mucosa erythema 12.04 11.72 5 34773 388 79709222
Derealisation 11.99 11.72 8 34770 1641 79707969
Inflammatory myofibroblastic tumour 11.96 11.72 4 34774 169 79709441
Violence-related symptom 11.93 11.72 6 34772 725 79708885
Pancytopenia 11.92 11.72 35 34743 165710 79543900
Self-injurious ideation 11.89 11.72 11 34767 3627 79705983
Locked-in syndrome 11.87 11.72 6 34772 733 79708877
Myositis 11.87 11.72 26 34752 19142 79690468
Fatigue 11.84 11.72 312 34466 929415 78780195
Hiccups 11.84 11.72 18 34760 10013 79699597
Dermatitis atopic 11.81 11.72 18 34760 10038 79699572
Eosinophil count abnormal 11.78 11.72 6 34772 745 79708865
Hypotension 11.77 11.72 129 34649 440188 79269422
Coma 11.76 11.72 16 34762 100633 79608977

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A07EA07 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
INTESTINAL ANTIINFLAMMATORY AGENTS
Corticosteroids acting locally
ATC D07AC15 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, potent (group III)
ATC D07CC04 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS
Corticosteroids, potent, combinations with antibiotics
ATC R01AD01 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC R03AK08 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AK13 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
ATC R03AL09 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
ADRENERGICS, INHALANTS
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC R03BA01 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:35472 anti-inflammatory drugs
CHEBI has role CHEBI:49167 anti-asthmatic drugs
CHEBI has role CHEBI:38070 antiarrhythmic agent
CHEBI has role CHEBI:50266 Prodrugs
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D005938 Glucocorticoids
MeSH PA D006728 Hormones
MeSH PA D019141 Respiratory System Agents
MeSH PA D001993 Bronchodilator Agents
MeSH PA D018373 Peripheral Nervous System Agents

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

DiseaseRelationSNOMED_IDDOID
Vasomotor rhinitis indication 8229003 DOID:4730
Nasal polyp indication 52756005
Allergic rhinitis indication 61582004
Rhinitis indication 70076002 DOID:4483
Asthma indication 195967001 DOID:2841
Asthma management indication 406162001
Severe chronic obstructive pulmonary disease off-label use 313299006
Mycosis contraindication 3218000 DOID:1564
Ocular hypertension contraindication 4210003 DOID:9282
Inactive tuberculosis contraindication 11999007
Epistaxis contraindication 12441001
Measles contraindication 14189004 DOID:8622
Disease caused by parasite contraindication 17322007
Glaucoma contraindication 23986001 DOID:1686
Acute tuberculosis contraindication 25629007
Perforation of nasal septum contraindication 80142000
Bacterial infectious disease contraindication 87628006
Mycobacteriosis contraindication 88415009
Operation on nose contraindication 88733004
Bilateral cataracts contraindication 95722004
Ophthalmic herpes simplex contraindication 186542001
Disease of liver contraindication 235856003 DOID:409
Varicella-zoster virus infection contraindication 309465005
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Exposure to varicella contraindication 444453009
Nasal Trauma contraindication
Nasal Candidiasis contraindication
Nasal Septal Ulcers contraindication
Uncontrolled Bacterial Infections contraindication
Untreated Fungal Infection contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.01 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST Ki 8.43 DRUG MATRIX CHEMBL
Interleukin-5 Cytokine IC50 4.57 CHEMBL
Mineralocorticoid receptor Nuclear hormone receptor EC50 8.32 CHEMBL
Matrix metalloproteinase-9 Enzyme IC50 5.70 CHEMBL
Probable G-protein coupled receptor 97 GPCR AGONIST EC50 8.50 IUPHAR
Progesterone receptor Nuclear hormone receptor IC50 7.55 CHEMBL
Androgen receptor Transcription factor Ki 5.96 CHEMBL
Progesterone receptor Transcription factor Ki 7.57 CHEMBL
Glucocorticoid receptor Transcription factor IC50 8.54 CHEMBL
Interleukin-5 Unclassified IC50 4.58 CHEMBL
Interleukin-5 receptor subunit alpha Unclassified IC50 4.58 CHEMBL

External reference:

IDSource
D00689 KEGG_DRUG
77011-63-3 SECONDARY_CAS_RN
1347 RXNORM
C0004906 UMLSCUI
CHEBI:3002 CHEBI
CHEBI:3001 CHEBI
CHEMBL1200500 ChEMBL_ID
CHEMBL1370 ChEMBL_ID
DB00394 DRUGBANK_ID
5894 IUPHAR_LIGAND_ID
21700 PUBCHEM_CID
1167 MMSL
4249 MMSL
71834 MMSL
8263 MMSL
d00760 MMSL
116574000 SNOMEDCT_US
116575004 SNOMEDCT_US
1389007 SNOMEDCT_US
426017007 SNOMEDCT_US
D019819 MESH_DESCRIPTOR_UI
D001507 MESH_DESCRIPTOR_UI
C0004905 UMLSCUI
4018793 VANDF
4019625 VANDF
2307 INN_ID
4419-39-0 SECONDARY_CAS_RN
20469 PUBCHEM_CID
7059 IUPHAR_LIGAND_ID
5B307S63B2 UNII
KGZ1SLC28Z UNII
002179 NDDF
004947 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
BECONASEAQ HUMAN PRESCRIPTION DRUG LABEL 1 0173-0388 SPRAY, SUSPENSION 42 ug NASAL NDA 20 sections
BECONASEAQ HUMAN PRESCRIPTION DRUG LABEL 1 0173-0388 SPRAY, SUSPENSION 42 ug NASAL NDA 20 sections
BECONASEAQ HUMAN PRESCRIPTION DRUG LABEL 1 0173-0388 SPRAY, SUSPENSION 42 ug NASAL NDA 20 sections
BECONASE AQ HUMAN PRESCRIPTION DRUG LABEL 1 16590-030 SPRAY, SUSPENSION 42 ug NASAL NDA 13 sections
QVAR HUMAN PRESCRIPTION DRUG LABEL 1 16590-860 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 26 sections
QVAR HUMAN PRESCRIPTION DRUG LABEL 1 50090-1342 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 28 sections
QVAR HUMAN PRESCRIPTION DRUG LABEL 1 50090-3033 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 28 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 50090-3459 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 16 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 50090-5031 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 50090-5032 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 53002-2436 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 53002-2436 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 53002-3477 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 53002-3477 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR HUMAN PRESCRIPTION DRUG LABEL 1 54868-5857 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 14 sections
QVAR HUMAN PRESCRIPTION DRUG LABEL 1 54868-5858 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 14 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 59310-302 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 59310-302 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 59310-302 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 59310-302 AEROSOL, METERED 40 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 59310-304 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 59310-304 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 59310-304 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 17 sections
QVAR REDIHALER HUMAN PRESCRIPTION DRUG LABEL 1 59310-304 AEROSOL, METERED 80 ug RESPIRATORY (INHALATION) NDA 17 sections
QNASL HUMAN PRESCRIPTION DRUG LABEL 1 59310-406 AEROSOL, METERED 40 ug NASAL NDA 27 sections
QNASL HUMAN PRESCRIPTION DRUG LABEL 1 59310-406 AEROSOL, METERED 40 ug NASAL NDA 27 sections
QNASL HUMAN PRESCRIPTION DRUG LABEL 1 59310-406 AEROSOL, METERED 40 ug NASAL NDA 27 sections
QNASL HUMAN PRESCRIPTION DRUG LABEL 1 59310-410 AEROSOL, METERED 80 ug NASAL NDA 27 sections
QNASL HUMAN PRESCRIPTION DRUG LABEL 1 59310-410 AEROSOL, METERED 80 ug NASAL NDA 27 sections
QNASL HUMAN PRESCRIPTION DRUG LABEL 1 59310-410 AEROSOL, METERED 80 ug NASAL NDA 27 sections