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

Stem definitionDrug idCAS RN
antibiotics, produced by Streptomyces strains 2684 32986-56-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • vantobra
  • tobramycin
  • Nebramycin 6
  • Nebramycin VI
  • tobracin
  • tobradistin
  • tobralex
  • tobramaxin
  • tobramicin
  • tobramycetin
  • tobramycin sulfate
  • nebcin
  • Tobi Podhaler
An aminoglycoside, broad-spectrum antibiotic produced by Streptomyces tenebrarius. It is effective against gram-negative bacteria, especially the PSEUDOMONAS species. It is a 10% component of the antibiotic complex, NEBRAMYCIN, produced by the same species.
  • Molecular weight: 467.52
  • Formula: C18H37N5O9
  • CLOGP: -3.44
  • LIPINSKI: 2
  • HAC: 14
  • HDO: 10
  • TPSA: 268.17
  • ALOGS: -0.94
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.11 g Inhal.powder
0.30 g Inhal.solution
0.24 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 50 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 93 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 19.25 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 1 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.23 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.60 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 1 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,BRAF,CAMK2D,CDK4,CDK5,DYRK1B,EIF2AK3,GRK2,ITK,MAP2K6,MAP3K21,MAPK10,MAPK7,NTRK1,NTRK2,PDK2,PDK4,PRKDC,TEK,TGFBR1 20
kinase-selectivity-class CHUK,IRAK4,MAP2K6,PDK1 4
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
July 20, 2011 EMA MYLAN IRELAND LIMITED
June 11, 1975 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
Infective pulmonary exacerbation of cystic fibrosis 1951.85 14.83 454 19869 9825 90598299
Hospitalisation 612.37 14.83 372 19951 127728 90480396
Cystic fibrosis 407.38 14.83 107 20216 3834 90604290
Pseudomonas infection 285.25 14.83 112 20211 14753 90593371
Pulmonary function test decreased 271.11 14.83 80 20243 4414 90603710
Acute kidney injury 238.96 14.83 325 19998 320062 90288062
Haemoptysis 229.33 14.83 123 20200 33197 90574927
Cough 184.83 14.83 311 20012 368651 90239473
Pneumonia 148.72 14.83 393 19930 637666 89970458
Conjunctival hyperaemia 138.29 14.83 44 20279 3125 90604999
Death 131.34 14.83 305 20018 456246 90151878
Renal tubular necrosis 118.03 14.83 60 20263 14495 90593629
Anti-neutrophil cytoplasmic antibody positive vasculitis 116.72 14.83 41 20282 3952 90604172
Drug resistance 106.90 14.83 73 20250 30376 90577748
Cystic fibrosis respiratory infection suppression 96.17 14.83 21 20302 334 90607790
Antibiotic level above therapeutic 94.35 14.83 22 20301 476 90607648
Ventilation perfusion mismatch 90.57 14.83 22 20301 570 90607554
Sputum increased 85.05 14.83 30 20293 2927 90605197
Forced expiratory volume decreased 84.83 14.83 36 20287 5772 90602352
Corneal perforation 84.76 14.83 21 20302 592 90607532
Ototoxicity 84.59 14.83 27 20296 1937 90606187
Bronchiectasis 84.28 14.83 56 20267 22274 90585850
Hypopyon 81.09 14.83 22 20301 892 90607232
Cystic fibrosis lung 77.79 14.83 15 20308 123 90608001
Corneal oedema 73.18 14.83 24 20299 1877 90606247
Staphylococcal infection 69.51 14.83 69 20254 48370 90559754
Systemic lupus erythematosus 68.41 14.83 3 20320 361893 90246231
Proteinuria 68.22 14.83 50 20273 23241 90584883
Aplastic anaemia 66.95 14.83 40 20283 13229 90594895
Disease complication 63.93 14.83 26 20297 3746 90604378
Tinnitus 62.97 14.83 62 20261 43040 90565084
Corneal infiltrates 62.78 14.83 13 20310 158 90607966
Dyspnoea 61.75 14.83 372 19951 880583 89727541
Synovitis 61.46 14.83 3 20320 329749 90278375
Pneumonia pseudomonal 60.95 14.83 24 20299 3179 90604945
Off label use 60.09 14.83 437 19886 1101815 89506309
Glossodynia 59.74 14.83 3 20320 321776 90286348
Bronchospasm 59.62 14.83 44 20279 20665 90587459
Corneal epithelium defect 58.83 14.83 15 20308 476 90607648
Infection 57.36 14.83 195 20128 361899 90246225
Infusion related reaction 56.99 14.83 12 20311 416768 90191356
Dysphonia 56.16 14.83 70 20253 63014 90545110
Endophthalmitis 55.30 14.83 25 20298 4660 90603464
Vasculitis 51.77 14.83 42 20281 22651 90585473
Productive cough 50.99 14.83 74 20249 76989 90531135
Visual acuity reduced 50.62 14.83 42 20281 23368 90584756
Wound 49.99 14.83 5 20318 302975 90305149
Abdominal discomfort 48.85 14.83 23 20300 477305 90130819
Nephropathy toxic 48.31 14.83 32 20291 12656 90595468
Drug level increased 48.30 14.83 44 20279 27718 90580406
Ocular hyperaemia 48.22 14.83 48 20275 33750 90574374
Lung transplant 47.74 14.83 21 20302 3671 90604453
Eye pain 47.54 14.83 54 20269 44114 90564010
Pneumothorax 46.98 14.83 37 20286 19130 90588994
Deafness 45.81 14.83 39 20284 22475 90585649
Drug reaction with eosinophilia and systemic symptoms 45.55 14.83 52 20271 42706 90565418
Corneal opacity 45.39 14.83 14 20309 897 90607227
Pseudomonas test positive 45.32 14.83 14 20309 902 90607222
Infective exacerbation of bronchiectasis 44.83 14.83 12 20311 462 90607662
Keratitis fungal 43.68 14.83 10 20313 199 90607925
Chest discomfort 42.43 14.83 95 20228 138270 90469854
Arthropathy 41.74 14.83 15 20308 366227 90241897
Mobility decreased 41.72 14.83 4 20319 250730 90357394
Eye irritation 40.81 14.83 44 20279 33934 90574190
SLE arthritis 39.92 14.83 12 20311 705 90607419
Psoriatic arthropathy 39.75 14.83 3 20320 228332 90379792
Ulcerative keratitis 39.41 14.83 18 20305 3435 90604689
Pelvic kidney 38.07 14.83 8 20315 105 90608019
Swelling 37.33 14.83 24 20299 419034 90189090
Aphonia 37.33 14.83 27 20296 12292 90595832
Pathogen resistance 37.18 14.83 23 20300 8092 90600032
Conjunctival oedema 36.36 14.83 12 20311 957 90607167
Condition aggravated 35.70 14.83 242 20081 595303 90012821
Acute generalised exanthematous pustulosis 34.76 14.83 27 20296 13676 90594448
Eyelid oedema 34.31 14.83 25 20298 11509 90596615
Increased bronchial secretion 33.63 14.83 14 20309 2139 90605985
Retinopathy of prematurity 33.17 14.83 9 20314 365 90607759
Burkholderia cepacia complex infection 32.76 14.83 8 20315 212 90607912
Stenotrophomonas infection 31.46 14.83 14 20309 2515 90605609
Elbow deformity 31.15 14.83 12 20311 1499 90606625
Hypoxia 30.86 14.83 57 20266 72342 90535782
Pain 30.37 14.83 118 20205 996223 89611901
Alopecia 30.31 14.83 40 20283 495031 90113093
Rhinovirus infection 30.14 14.83 18 20305 5945 90602179
Therapeutic product effect incomplete 29.98 14.83 4 20319 193892 90414232
Discomfort 29.97 14.83 12 20311 274323 90333801
Impaired healing 29.51 14.83 8 20315 234191 90373933
Sputum discoloured 29.16 14.83 29 20294 20362 90587762
Lower respiratory tract infection 29.00 14.83 10 20313 250649 90357475
Peripheral swelling 28.91 14.83 30 20293 413076 90195048
Therapy cessation 28.66 14.83 38 20285 36323 90571801
Lung disorder 28.48 14.83 86 20237 149797 90458327
Sweat test abnormal 28.23 14.83 5 20318 24 90608100
Mycobacterium chelonae infection 28.16 14.83 9 20314 648 90607476
Intentional product use issue 28.11 14.83 7 20316 216885 90391239
Blister 28.10 14.83 11 20312 254987 90353137
Corneal disorder 27.65 14.83 12 20311 2030 90606094
Renal failure 27.60 14.83 78 20245 130929 90477195
Confusional state 27.07 14.83 28 20295 386177 90221947
Eye swelling 26.77 14.83 33 20290 29353 90578771
Hypoaesthesia 26.62 14.83 19 20304 314191 90293933
Fibromyalgia 26.08 14.83 7 20316 206262 90401862
Distal intestinal obstruction syndrome 25.90 14.83 8 20315 515 90607609
Lipogranuloma 25.57 14.83 4 20319 7 90608117
Corneal neovascularisation 25.10 14.83 6 20317 145 90607979
Blood cholesterol increased 24.58 14.83 8 20315 208004 90400120
Jaw fracture 24.54 14.83 12 20311 2666 90605458
Ocular discomfort 24.09 14.83 16 20307 6354 90601770
Hypertension 24.09 14.83 41 20282 457491 90150633
Pneumonia staphylococcal 23.80 14.83 13 20310 3628 90604496
Hepatic enzyme increased 23.26 14.83 28 20295 360708 90247416
Retinal detachment 23.09 14.83 16 20307 6806 90601318
Stomatitis 22.76 14.83 17 20306 274681 90333443
Renal impairment 22.43 14.83 63 20260 105358 90502766
Respiratory tract infection bacterial 22.29 14.83 7 20316 476 90607648
Foreign body sensation in eyes 22.18 14.83 12 20311 3288 90604836
Respirovirus test positive 21.69 14.83 4 20319 25 90608099
C-reactive protein increased 21.39 14.83 7 20316 181382 90426742
Liver injury 21.16 14.83 6 20317 170561 90437563
Product administered to patient of inappropriate age 20.84 14.83 13 20310 4640 90603484
Antimicrobial susceptibility test intermediate 20.83 14.83 4 20319 32 90608092
Bacterial infection 20.83 14.83 26 20297 23418 90584706
Gait inability 20.44 14.83 4 20319 146452 90461672
Vitritis 20.29 14.83 9 20314 1605 90606519
Intraocular pressure increased 20.25 14.83 15 20308 7078 90601046
Contusion 20.24 14.83 16 20307 251200 90356924
Ocular hypertension 19.94 14.83 9 20314 1671 90606453
Corneal thinning 19.72 14.83 5 20318 155 90607969
Rash maculo-papular 19.72 14.83 34 20289 40899 90567225
Sinonasal papilloma 19.60 14.83 4 20319 45 90608079
Keratitis bacterial 19.21 14.83 4 20319 50 90608074
Manufacturing laboratory analytical testing issue 18.92 14.83 3 20320 6 90608118
Oxygen saturation decreased 18.86 14.83 60 20263 107423 90500701
Respiration abnormal 18.71 14.83 15 20308 7948 90600176
Cystic fibrosis related diabetes 18.47 14.83 4 20319 61 90608063
Vitreous opacities 18.36 14.83 6 20317 464 90607660
Tracheostomy infection 18.24 14.83 4 20319 65 90608059
Eye discharge 18.23 14.83 15 20308 8243 90599881
Blood creatinine increased 18.16 14.83 57 20266 101329 90506795
Respiratory failure 18.02 14.83 63 20260 118355 90489769
Clubbing 17.99 14.83 6 20317 494 90607630
Lacrimation increased 17.91 14.83 26 20297 27036 90581088
Macular oedema 17.77 14.83 12 20311 4897 90603227
Pancreatic failure 17.73 14.83 8 20315 1484 90606640
Tubulointerstitial nephritis 17.73 14.83 25 20298 25318 90582806
Paraesthesia 17.70 14.83 18 20305 250308 90357816
Osteoarthritis 17.70 14.83 11 20312 195719 90412405
General physical health deterioration 17.62 14.83 33 20290 355082 90253042
Bronchial disorder 17.44 14.83 8 20315 1542 90606582
Pupillary block 17.38 14.83 3 20320 12 90608112
Spirometry abnormal 17.04 14.83 5 20318 270 90607854
Respiratory symptom 16.86 14.83 11 20312 4241 90603883
Aspergilloma 16.79 14.83 5 20318 284 90607840
Multiple organ dysfunction syndrome 16.71 14.83 43 20280 68293 90539831
Weight increased 16.51 14.83 44 20279 417883 90190241
Bartter's syndrome 16.24 14.83 3 20320 19 90608105
Vitreous haemorrhage 16.13 14.83 9 20314 2617 90605507
Retinal haemorrhage 16.04 14.83 12 20311 5752 90602372
Pulmonary function test abnormal 15.78 14.83 9 20314 2730 90605394
Contraindicated product administered 15.66 14.83 30 20293 320109 90288015
Bronchopulmonary aspergillosis allergic 15.56 14.83 10 20313 3756 90604368
Anterior chamber fibrin 15.54 14.83 4 20319 132 90607992
Acinetobacter infection 15.47 14.83 8 20315 2000 90606124
Injection site pain 15.38 14.83 10 20313 173689 90434435
Perineal necrosis 15.37 14.83 4 20319 138 90607986
Pain in extremity 15.23 14.83 51 20272 450478 90157646
Underweight 15.09 14.83 7 20316 1383 90606741
Central nervous system fungal infection 15.07 14.83 4 20319 149 90607975
Bronchial wall thickening 15.02 14.83 8 20315 2123 90606001
Therapy interrupted 14.89 14.83 34 20289 50074 90558050

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
Infective pulmonary exacerbation of cystic fibrosis 1629.58 16.22 417 16712 7401 42596805
Hospitalisation 500.08 16.22 332 16797 73998 42530208
Cystic fibrosis 305.29 16.22 84 17045 1971 42602235
Pulmonary function test decreased 220.59 16.22 84 17045 5648 42598558
Pseudomonas infection 203.90 16.22 108 17021 15815 42588391
Choroiditis 180.40 16.22 51 17078 1324 42602882
Endophthalmitis 152.89 16.22 60 17069 4373 42599833
Ototoxicity 150.00 16.22 50 17079 2275 42601931
Eye pain 146.35 16.22 89 17040 16941 42587265
Intraocular pressure increased 137.68 16.22 62 17067 6371 42597835
Pneumonia 132.23 16.22 420 16709 421729 42182477
Cough 130.17 16.22 246 16883 177857 42426349
Visual acuity reduced 128.85 16.22 83 17046 17467 42586739
Infection 123.41 16.22 186 16943 111882 42492324
Haemoptysis 106.37 16.22 111 17018 46056 42558150
Ill-defined disorder 95.46 16.22 67 17062 16229 42587977
Cystic fibrosis respiratory infection suppression 94.58 16.22 22 17107 253 42603953
Sputum increased 92.42 16.22 38 17091 3125 42601081
Condition aggravated 88.28 16.22 267 16862 260487 42343719
Sputum discoloured 87.15 16.22 53 17076 10079 42594127
Uveitis 83.69 16.22 50 17079 9208 42594998
Productive cough 79.88 16.22 101 17028 51466 42552740
Vitamin K deficiency 70.44 16.22 19 17110 412 42603794
Lung transplant 64.10 16.22 27 17102 2359 42601847
Disease complication 63.82 16.22 29 17100 3041 42601165
Painful respiration 63.42 16.22 23 17106 1346 42602860
Drug resistance 61.00 16.22 72 17057 34176 42570030
Renal tubular necrosis 60.94 16.22 54 17075 18300 42585906
Aplastic anaemia 59.11 16.22 45 17084 12339 42591867
Pathogen resistance 55.52 16.22 42 17087 11408 42592798
Forced expiratory volume decreased 53.32 16.22 35 17094 7595 42596611
Dyspnoea 51.87 16.22 329 16800 442292 42161914
Bronchospasm 51.13 16.22 42 17087 12843 42591363
Chest injury 50.22 16.22 21 17108 1801 42602405
Lung disorder 46.31 16.22 75 17054 47848 42556358
Walking aid user 45.83 16.22 22 17107 2611 42601595
Increased viscosity of bronchial secretion 45.22 16.22 12 17117 244 42603962
Toxic epidermal necrolysis 43.96 16.22 54 17075 26696 42577510
Retinopathy of prematurity 43.58 16.22 11 17118 182 42604024
Pneumonia pseudomonal 43.03 16.22 26 17103 4883 42599323
Influenza 42.94 16.22 84 17045 62091 42542115
Pancreatic failure 42.06 16.22 16 17113 1071 42603135
Hypoacusis 41.31 16.22 44 17085 18658 42585548
Linear IgA disease 41.00 16.22 19 17110 2084 42602122
Keratitis 40.67 16.22 18 17111 1773 42602433
Cystic fibrosis related diabetes 38.42 16.22 10 17119 188 42604018
Infective keratitis 38.33 16.22 8 17121 53 42604153
Oxygen saturation decreased 38.29 16.22 82 17047 64605 42539601
Off label use 37.12 16.22 405 16724 637930 41966276
Nephropathy toxic 36.11 16.22 39 17090 16799 42587407
Product administered to patient of inappropriate age 33.65 16.22 22 17107 4739 42599467
Infective exacerbation of bronchiectasis 33.26 16.22 11 17118 488 42603718
Arthralgia 32.86 16.22 21 17108 205217 42398989
Death 32.59 16.22 310 16819 470875 42133331
Fall 32.39 16.22 28 17101 234492 42369714
Keratitis bacterial 32.30 16.22 8 17121 122 42604084
Pseudomonas test positive 30.98 16.22 14 17115 1449 42602757
Deafness 30.96 16.22 32 17097 13108 42591098
Deafness neurosensory 30.69 16.22 19 17110 3727 42600479
Respiratory disorder 30.65 16.22 41 17088 22044 42582162
Vestibular disorder 30.55 16.22 13 17116 1164 42603042
Increased bronchial secretion 30.25 16.22 16 17113 2330 42601876
Somnolence 29.42 16.22 10 17119 141095 42463111
Respiratory tract irritation 29.23 16.22 9 17120 316 42603890
Distal intestinal obstruction syndrome 29.14 16.22 10 17119 497 42603709
Rhonchi 28.86 16.22 15 17114 2108 42602098
Aphonia 28.74 16.22 19 17110 4170 42600036
Staphylococcal infection 27.37 16.22 52 17077 37591 42566615
Acute kidney injury 27.02 16.22 245 16884 367092 42237114
Corneal epithelium defect 26.92 16.22 9 17120 413 42603793
Aortic aneurysm 26.18 16.22 23 17106 7700 42596506
Cystic fibrosis lung 25.71 16.22 6 17123 70 42604136
Tracheostomy 25.43 16.22 11 17118 1026 42603180
Infective corneal ulcer 25.15 16.22 5 17124 25 42604181
Chest discomfort 24.14 16.22 68 17061 63548 42540658
Rash morbilliform 24.13 16.22 17 17112 4136 42600070
Malignant neoplasm progression 23.81 16.22 7 17122 108393 42495813
Tinnitus 23.59 16.22 42 17087 28896 42575310
Oral candidiasis 23.53 16.22 29 17100 14376 42589830
Ulcerative keratitis 23.47 16.22 13 17116 2075 42602131
Factor V inhibition 23.38 16.22 7 17122 223 42603983
Rubber sensitivity 23.27 16.22 8 17121 400 42603806
Wheezing 23.23 16.22 61 17068 54720 42549486
Bronchiectasis 22.81 16.22 32 17097 17987 42586219
Product use issue 22.54 16.22 75 17054 76676 42527530
Nausea 22.44 16.22 83 17046 396716 42207490
Toxic anterior segment syndrome 22.15 16.22 11 17118 1405 42602801
Anaemia 22.15 16.22 50 17079 280228 42323978
Ocular hypertension 21.28 16.22 10 17119 1131 42603075
Hypopyon 21.15 16.22 8 17121 527 42603679
Corneal thinning 21.03 16.22 6 17123 161 42604045
Mycobacterium chelonae infection 20.98 16.22 10 17119 1168 42603038
Corneal infiltrates 20.68 16.22 6 17123 171 42604035
Cronobacter infection 20.12 16.22 4 17125 20 42604186
Chondritis 20.02 16.22 6 17123 192 42604014
Necrotising scleritis 19.97 16.22 5 17124 80 42604126
Eyelid oedema 19.38 16.22 17 17112 5678 42598528
Tracheitis 19.06 16.22 9 17120 1030 42603176
Malaise 19.00 16.22 148 16981 212008 42392198
Febrile convulsion 18.97 16.22 8 17121 701 42603505
Flavobacterium infection 18.96 16.22 5 17124 99 42604107
Erythema of eyelid 18.67 16.22 10 17119 1493 42602713
Post procedural complication 18.43 16.22 24 17105 12566 42591640
Pain in extremity 18.43 16.22 20 17109 150584 42453622
Lipogranuloma 18.38 16.22 3 17126 3 42604203
Antibiotic therapy 18.34 16.22 5 17124 113 42604093
Ocular hyperaemia 18.23 16.22 27 17102 15936 42588270
Joint swelling 17.73 16.22 3 17126 68019 42536187
Chronic sinusitis 17.68 16.22 13 17116 3379 42600827
Neuralgic amyotrophy 17.53 16.22 6 17123 296 42603910
Scleromalacia 17.36 16.22 4 17125 44 42604162
Rhinovirus infection 17.35 16.22 17 17112 6531 42597675
Carbon dioxide increased 17.33 16.22 9 17120 1263 42602943
Haemodialysis 17.32 16.22 21 17108 10239 42593967
Staphylococcal sepsis 17.09 16.22 22 17107 11392 42592814
Moaning 16.98 16.22 8 17121 911 42603295
Eyelids pruritus 16.66 16.22 6 17123 344 42603862
Hypertension 16.56 16.22 26 17103 167178 42437028
Overdose 16.52 16.22 11 17118 105253 42498953
Muscle spasms 16.42 16.22 7 17122 86037 42518169
Feeling cold 16.36 16.22 23 17106 12950 42591256
Device related thrombosis 16.25 16.22 9 17120 1436 42602770

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
Infective pulmonary exacerbation of cystic fibrosis 2678.85 13.97 650 28893 14121 110545635
Hospitalisation 694.98 13.97 447 29096 142046 110417710
Cystic fibrosis 530.08 13.97 142 29401 4589 110555167
Pulmonary function test decreased 375.70 13.97 125 29418 8575 110551181
Pseudomonas infection 317.39 13.97 153 29390 27700 110532056
Haemoptysis 264.13 13.97 189 29354 71165 110488591
Acute kidney injury 258.18 13.97 541 29002 634889 109924867
Ototoxicity 201.10 13.97 65 29478 4066 110555690
Renal tubular necrosis 197.86 13.97 115 29428 30360 110529396
Endophthalmitis 181.84 13.97 72 29471 8115 110551641
Choroiditis 178.64 13.97 48 29495 1567 110558189
Visual acuity reduced 174.11 13.97 108 29435 32065 110527691
Pneumonia 169.53 13.97 566 28977 876148 109683608
Eye pain 165.65 13.97 124 29419 49975 110509781
Cough 164.21 13.97 373 29170 461268 110098488
Intraocular pressure increased 158.91 13.97 71 29472 10805 110548951
Sputum increased 150.57 13.97 57 29486 5694 110554062
Conjunctival hyperaemia 135.54 13.97 53 29490 5778 110553978
Cystic fibrosis respiratory infection suppression 133.24 13.97 30 29513 459 110559297
Drug resistance 131.98 13.97 114 29429 56260 110503496
Disease complication 128.55 13.97 51 29492 5776 110553980
Death 127.61 13.97 443 29100 698426 109861330
Aplastic anaemia 127.48 13.97 80 29463 24228 110535528
Forced expiratory volume decreased 105.29 13.97 57 29486 13119 110546637
Cystic fibrosis lung 94.98 13.97 19 29524 158 110559598
Pathogen resistance 94.78 13.97 59 29484 17613 110542143
Corneal perforation 94.47 13.97 26 29517 930 110558826
Antibiotic level above therapeutic 92.47 13.97 26 29517 1007 110558749
Nephropathy toxic 90.78 13.97 68 29475 27410 110532346
Pneumonia pseudomonal 90.63 13.97 43 29500 7503 110552253
Hypopyon 88.18 13.97 27 29516 1413 110558343
Sputum discoloured 87.55 13.97 67 29476 27878 110531878
Corneal oedema 85.06 13.97 32 29511 3141 110556615
Condition aggravated 82.45 13.97 401 29142 734435 109825321
Productive cough 81.86 13.97 125 29418 114180 110445576
Anti-neutrophil cytoplasmic antibody positive vasculitis 81.17 13.97 36 29507 5381 110554375
Ventilation perfusion mismatch 80.26 13.97 22 29521 775 110558981
Ulcerative keratitis 78.98 13.97 34 29509 4732 110555024
Lung transplant 78.79 13.97 35 29508 5251 110554505
Corneal epithelium defect 77.32 13.97 22 29521 890 110558866
Corneal infiltrates 75.98 13.97 18 29525 348 110559408
Uveitis 74.57 13.97 55 29488 21655 110538101
Tinnitus 72.30 13.97 85 29458 60455 110499301
Staphylococcal infection 68.69 13.97 89 29454 69855 110489901
Bronchospasm 68.44 13.97 60 29483 30179 110529577
Corneal opacity 66.29 13.97 21 29522 1230 110558526
Drug level increased 65.46 13.97 72 29471 47647 110512109
Bronchiectasis 64.35 13.97 63 29480 36430 110523326
Dyspnoea 62.28 13.97 506 29037 1106366 109453390
Infective exacerbation of bronchiectasis 60.41 13.97 18 29525 858 110558898
Off label use 58.50 13.97 634 28909 1499551 109060205
Keratitis fungal 57.89 13.97 15 29528 424 110559332
Systemic lupus erythematosus 55.66 13.97 3 29540 254335 110305421
Toxic epidermal necrolysis 55.41 13.97 72 29471 56655 110503101
Ocular hyperaemia 53.41 13.97 59 29484 39227 110520529
Completed suicide 52.60 13.97 3 29540 242378 110317378
Hypoacusis 51.60 13.97 55 29488 35136 110524620
Vitamin K deficiency 51.05 13.97 16 29527 905 110558851
Conjunctival oedema 50.25 13.97 18 29525 1538 110558218
Painful respiration 50.10 13.97 23 29520 3724 110556032
Keratitis 48.91 13.97 25 29518 5119 110554637
Mobility decreased 48.43 13.97 4 29539 237418 110322338
Therapeutic product effect decreased 47.48 13.97 5 29538 244311 110315445
Glossodynia 47.41 13.97 3 29540 222001 110337755
Aphonia 47.39 13.97 34 29509 12826 110546930
Cystic fibrosis related diabetes 46.27 13.97 11 29532 216 110559540
Chest injury 45.82 13.97 21 29522 3388 110556368
Infusion related reaction 44.71 13.97 23 29520 381139 110178617
Pneumothorax 44.56 13.97 51 29492 35234 110524522
Lipogranuloma 44.39 13.97 7 29536 10 110559746
Eyelid oedema 44.34 13.97 35 29508 15227 110544529
Deafness neurosensory 43.86 13.97 29 29514 9590 110550166
Pericarditis 43.85 13.97 4 29539 219110 110340646
Deafness 43.20 13.97 44 29499 26665 110533091
Rhinovirus infection 43.05 13.97 31 29512 11758 110547998
Pseudomonas test positive 43.01 13.97 18 29525 2336 110557420
Pancreatic failure 43.01 13.97 18 29525 2336 110557420
Ocular hypertension 42.62 13.97 18 29525 2390 110557366
Infective keratitis 41.77 13.97 9 29534 111 110559645
Corneal neovascularisation 41.66 13.97 10 29533 205 110559551
Infection 41.43 13.97 199 29344 362001 110197755
Distal intestinal obstruction syndrome 41.36 13.97 14 29529 1011 110558745
Psoriatic arthropathy 41.01 13.97 3 29540 196758 110362998
Linear IgA disease 40.77 13.97 21 29522 4368 110555388
Keratitis bacterial 40.52 13.97 10 29533 231 110559525
Wound 40.34 13.97 7 29536 234430 110325326
Swelling 39.97 13.97 22 29521 351019 110208737
Increased bronchial secretion 39.91 13.97 20 29523 3928 110555828
Increased viscosity of bronchial secretion 39.45 13.97 12 29531 614 110559142
Acute generalised exanthematous pustulosis 39.32 13.97 38 29505 21626 110538130
Drug reaction with eosinophilia and systemic symptoms 39.20 13.97 75 29468 82020 110477736
Oxygen saturation decreased 39.06 13.97 111 29432 156871 110402885
Corneal thinning 39.00 13.97 10 29533 271 110559485
Product administered to patient of inappropriate age 38.53 13.97 25 29518 8011 110551745
Mycobacterium chelonae infection 38.48 13.97 18 29525 3042 110556714
Abdominal discomfort 37.67 13.97 30 29513 393828 110165928
Arthropathy 37.38 13.97 15 29528 287507 110272249
Fall 36.43 13.97 66 29477 603416 109956340
Fibromyalgia 34.52 13.97 3 29540 170906 110388850
Influenza 34.04 13.97 111 29432 168990 110390766
Chest discomfort 34.00 13.97 113 29430 173735 110386021
Necrotising scleritis 33.84 13.97 9 29534 282 110559474
Drug abuse 33.54 13.97 4 29539 177407 110382349
Vestibular disorder 31.61 13.97 15 29528 2617 110557139
Aortic aneurysm 31.58 13.97 24 29519 9880 110549876
Rash morbilliform 31.56 13.97 22 29521 7929 110551827
SLE arthritis 30.91 13.97 10 29533 627 110559129
Eye irritation 30.42 13.97 41 29502 33411 110526345
Proteinuria 30.39 13.97 45 29498 39973 110519783
Osteoarthritis 30.24 13.97 6 29537 182617 110377139
Pain 29.55 13.97 143 29400 954812 109604944
Hypertension 28.83 13.97 58 29485 510026 110049730
Corneal disorder 28.76 13.97 14 29529 2583 110557173
Hypoaesthesia 28.72 13.97 25 29518 314198 110245558
Dry mouth 28.42 13.97 9 29534 199939 110359817
Discomfort 28.23 13.97 11 29532 214696 110345060
Stenotrophomonas infection 27.54 13.97 18 29525 5840 110553916
Aspergillus infection 27.36 13.97 34 29509 25582 110534174
Infective corneal ulcer 27.19 13.97 5 29538 25 110559731
Macular oedema 27.01 13.97 19 29524 6947 110552809
Scleromalacia 26.88 13.97 6 29537 88 110559668
Alopecia 26.67 13.97 35 29508 364718 110195038
Rhonchi 26.56 13.97 16 29527 4502 110555254
Stevens-Johnson syndrome 26.38 13.97 46 29497 46855 110512901
Pain in extremity 26.17 13.97 57 29486 487061 110072695
Erythema of eyelid 26.00 13.97 15 29528 3900 110555856
Multiple organ dysfunction syndrome 25.66 13.97 94 29449 151616 110408140
Dysphonia 25.38 13.97 60 29483 75869 110483887
Vasculitis 25.34 13.97 39 29504 35834 110523922
Blood cholesterol increased 25.07 13.97 9 29534 184776 110374980
Burkholderia cepacia complex infection 25.05 13.97 8 29535 481 110559275
Intentional overdose 25.01 13.97 3 29540 132498 110427258
Toxic anterior segment syndrome 25.00 13.97 14 29529 3440 110556316
Renal impairment 24.83 13.97 108 29435 188337 110371419
Clubbing 24.82 13.97 9 29534 796 110558960
Forced expiratory volume increased 24.59 13.97 6 29537 132 110559624
Somnolence 24.46 13.97 26 29517 297423 110262333
Tracheitis 24.39 13.97 11 29532 1710 110558046
Muscle spasms 24.38 13.97 23 29520 278134 110281622
Stomatitis 24.09 13.97 22 29521 270220 110289536
Therapy cessation 23.94 13.97 43 29500 44814 110514942
Sputum abnormal 23.33 13.97 10 29533 1376 110558380
Haemodialysis 23.03 13.97 26 29517 17693 110542063
Respiratory failure 22.94 13.97 116 29427 215216 110344540
Malignant neoplasm progression 22.85 13.97 9 29534 174558 110385198
Therapeutic product effect incomplete 22.73 13.97 16 29527 223789 110335967
Vitritis 22.66 13.97 12 29531 2641 110557115
Confusional state 22.65 13.97 58 29485 468622 110091134
Elbow deformity 22.51 13.97 10 29533 1500 110558256
Joint range of motion decreased 22.41 13.97 3 29540 121829 110437927
Pyrexia 22.28 13.97 350 29193 897915 109661841
Pneumonia staphylococcal 22.20 13.97 16 29527 6075 110553681
Lung disorder 22.08 13.97 101 29442 179946 110379810
Injection site pain 21.97 13.97 10 29533 177912 110381844
Candida infection 21.86 13.97 43 29500 47966 110511790
Cronobacter infection 21.75 13.97 4 29539 20 110559736
Post procedural complication 21.73 13.97 31 29512 26627 110533129
Respiratory tract irritation 21.72 13.97 8 29535 740 110559016
Gait inability 21.52 13.97 5 29538 136371 110423385
Respiratory distress 21.49 13.97 53 29490 68821 110490935
Mycobacterium abscessus infection 21.34 13.97 10 29533 1696 110558060
Respiratory disorder 21.30 13.97 54 29489 71328 110488428
Hypotony of eye 21.20 13.97 7 29536 468 110559288
Arthralgia 21.15 13.97 122 29421 779510 109780246
Pulmonary haemorrhage 21.14 13.97 24 29519 16432 110543324
Gait disturbance 21.05 13.97 26 29517 278182 110281574
Respiratory tract infection bacterial 20.84 13.97 11 29532 2405 110557351
Bronchial wall thickening 20.53 13.97 12 29531 3195 110556561
Antimicrobial susceptibility test intermediate 20.13 13.97 4 29539 32 110559724
Blood creatinine increased 19.82 13.97 99 29444 182790 110376966
Septic shock 19.78 13.97 89 29454 157439 110402317
Flavobacterium infection 19.66 13.97 5 29538 131 110559625
Contusion 19.63 13.97 20 29523 233341 110326415
Bacterial infection 19.49 13.97 40 29503 45996 110513760
Respiration abnormal 19.31 13.97 18 29525 9791 110549965
Eye discharge 19.07 13.97 17 29526 8737 110551019
Restrictive cardiomyopathy 19.01 13.97 8 29535 1053 110558703
Sweat test abnormal 18.98 13.97 4 29539 44 110559712
Sinonasal papilloma 18.98 13.97 4 29539 44 110559712
Rash maculo-papular 18.96 13.97 53 29490 74169 110485587
Neuralgic amyotrophy 18.78 13.97 6 29537 361 110559395
Insomnia 18.70 13.97 43 29500 360547 110199209
Febrile convulsion 18.66 13.97 8 29535 1102 110558654
Syncope 18.64 13.97 16 29527 202520 110357236
Overdose 18.60 13.97 21 29522 233773 110325983
Manufacturing laboratory analytical testing issue 18.39 13.97 3 29540 6 110559750
Staphylococcal sepsis 18.37 13.97 23 29520 17431 110542325
Photophobia 18.17 13.97 28 29515 25743 110534013
Surgical procedure repeated 18.12 13.97 7 29536 738 110559018
Peripheral swelling 18.01 13.97 52 29491 403982 110155774
Stenotrophomonas test positive 17.97 13.97 6 29537 415 110559341
C-reactive protein increased 17.97 13.97 19 29524 217900 110341856
Liver injury 17.73 13.97 9 29534 150404 110409352
Foreign body sensation in eyes 17.54 13.97 11 29532 3323 110556433
Conjunctivitis 17.53 13.97 32 29511 33760 110525996
Ocular discomfort 17.46 13.97 16 29527 8517 110551239
Dermatitis exfoliative 17.10 13.97 18 29525 11329 110548427
Corneal exfoliation 17.07 13.97 3 29540 11 110559745
Muscular weakness 16.99 13.97 25 29518 248443 110311313
Eye pruritus 16.96 13.97 31 29512 32744 110527012
Anaemia 16.83 13.97 82 29461 547004 110012752
Road traffic accident 16.82 13.97 4 29539 107394 110452362
Anterior chamber fibrin 16.65 13.97 5 29538 245 110559511
Infectious crystalline keratopathy 16.62 13.97 4 29539 83 110559673
Bursitis 16.51 13.97 7 29536 129911 110429845
Chondritis 16.47 13.97 5 29538 254 110559502
Impaired healing 16.39 13.97 17 29526 196700 110363056
Wound infection 16.33 13.97 3 29540 96462 110463294
Depression 16.32 13.97 38 29505 317297 110242459
Tracheostomy 16.22 13.97 8 29535 1519 110558237
Underweight 16.20 13.97 8 29535 1522 110558234
Steatorrhoea 15.73 13.97 7 29536 1054 110558702
Retinal detachment 15.66 13.97 17 29526 11083 110548673
Persistent corneal epithelial defect 15.65 13.97 4 29539 107 110559649
Psoriasis 15.59 13.97 9 29534 139984 110419772
Bartter's syndrome 15.58 13.97 3 29540 20 110559736
Jaw fracture 15.58 13.97 10 29533 3146 110556610
Hypoxia 15.39 13.97 72 29471 129443 110430313
Rubber sensitivity 15.36 13.97 9 29534 2409 110557347
Gastrointestinal haemorrhage 15.32 13.97 13 29530 165505 110394251
Weight increased 15.28 13.97 59 29484 419585 110140171
Herpes zoster 15.18 13.97 5 29538 108374 110451382
Contraindicated product administered 15.08 13.97 27 29516 248240 110311516
Joint swelling 15.03 13.97 64 29479 442781 110116975
Hypercholesterolaemia 15.00 13.97 3 29540 90834 110468922
Eyelids pruritus 14.99 13.97 8 29535 1789 110557967
Respirovirus test positive 14.90 13.97 4 29539 130 110559626
Dialysis 14.81 13.97 22 29521 19597 110540159
Angle closure glaucoma 14.64 13.97 10 29533 3489 110556267
Dizziness 14.57 13.97 118 29425 698075 109861681
Fatigue 14.56 13.97 233 29310 1215725 109344031
Blister 14.48 13.97 24 29519 227352 110332404
Acinetobacter infection 14.45 13.97 10 29533 3563 110556193
Lacrimation increased 14.43 13.97 28 29515 30922 110528834
Trichosporon infection 14.37 13.97 7 29536 1293 110558463
Factor V inhibition 14.32 13.97 5 29538 396 110559360
Vitamin E decreased 14.24 13.97 3 29540 33 110559723
Cognitive disorder 14.23 13.97 3 29540 87508 110472248
Bronchial disorder 14.21 13.97 9 29534 2767 110556989
Intentional product misuse 14.16 13.97 9 29534 132895 110426861
Vitamin E deficiency 14.16 13.97 3 29540 34 110559722
Osteopenia 14.10 13.97 23 29520 22186 110537570
Tubulointerstitial nephritis 14.10 13.97 39 29504 54245 110505511
Suicide attempt 14.08 13.97 5 29538 103389 110456367
Sputum retention 14.08 13.97 7 29536 1352 110558404
Vitamin A deficiency 14.03 13.97 4 29539 163 110559593
Carbon dioxide increased 14.01 13.97 9 29534 2835 110556921

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01GB01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
AMINOGLYCOSIDE ANTIBACTERIALS
Other aminoglycosides
ATC S01AA12 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFECTIVES
Antibiotics
FDA CS M0000946 Aminoglycosides
FDA EPC N0000175477 Aminoglycoside Antibacterial
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000900 Anti-Bacterial Agents
CHEBI has role CHEBI:27026 toxin
CHEBI has role CHEBI:33281 antimicrobial agent
CHEBI has role CHEBI:33282 antibacterial agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:67079 anti-inflammatory agent

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J01GB Other aminoglycosides 12 drugs
amikacinarbekacinbekanamycindibekacingentamicinisepamicinkanamycinneomycinnetilmicinplazomicinribostamycinsisomicin
S01AA Antibiotics 27 drugs
amikacinampicillinazidamfenicolazithromycinbacitracinbenzylpenicillincefmenoximecefuroximechloramphenicolchlortetracyclinedibekacindihydrostreptomycin show all 27 →

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

DiseaseRelationSNOMED_IDDOID
Septicemia due to Escherichia coli indication 9323009
Bacterial septicemia indication 10001005 DOID:0040085
Staphylococcal pneumonia indication 22754005
Pneumonia due to Pseudomonas indication 41381004
Punctate keratitis indication 42513006 DOID:12197
Pneumonia due to Escherichia coli indication 51530003
Blepharoconjunctivitis indication 68659002 DOID:2456
Infection due to Escherichia coli indication 71057007
Bacterial infection due to Serratia indication 71120004
Rhinoscleroma indication 72409005 DOID:11336
Perforation of cornea indication 74895004
Dacryocystitis indication 85777005 DOID:9938
Corneal abrasion indication 85848002
Keratoconjunctivitis indication 88151007 DOID:9368
Bacterial meningitis indication 95883001 DOID:9470
Infection of bone indication 111253001
Bacterial conjunctivitis indication 128350005 DOID:9700
Uveitis indication 128473001 DOID:13141
Infection due to Enterobacteriaceae indication 128945009
Bacterial infection due to Klebsiella pneumoniae indication 186435004
Bacterial peritonitis indication 197171003
Sepsis of the newborn indication 206376005
Neonatal meningitis indication 276674008
Escherichia coli urinary tract infection indication 301011002
Meibomianitis indication 309779001
Bacterial urinary infection indication 312124009
Infective blepharitis indication 312219000
Herpes zoster keratitis indication 397573005
Rosacea indication 398909004 DOID:8881
Infection due to Staphylococcus aureus indication 406602003
Anterior uveitis indication 410692006 DOID:1407
Nosocomial pneumonia indication 425464007
Osteomyelitis due to Staphylococcus aureus indication 428783003
Sepsis due to Pseudomonas indication 448813005
Allergic conjunctivitis indication 473460002 DOID:11204
Urinary tract infection caused by Klebsiella indication 369001000119100
Synergy for Nosocomial Pneumonia due to Pseudomonas Aeruginosa indication
Synergy for Neonatal Meningitis indication
Klebsiella Pneumoniae Peritonitis indication
Proteus Mirabilis Osteomyelitis indication
E. Coli Osteomyelitis indication
Skin and Skin Structure Proteus Infection indication
Complicated UTI with Pseudomonas Aeruginosa indication
Gram-Negative Aerobic Bacillary Pneumonia indication
Klebsiella Pneumoniae Osteomyelitis indication
Synergy for Staphylococcal Infections indication
Staphylococcus Aureus Complicated UTI indication
Complicated Proteus UTI indication
Citrobacter Complicated UTI indication
Enterobacter Osteomyelitis indication
Synergy for P. Aeruginosa Infection in Cystic Fibrosis indication
E. Coli Peritonitis indication
Complicated Urinary Tract Infections indication
Synergy for Bacterial Meningitis indication
Skin and Skin Structure Pseudomonas Aeruginosa Infection indication
Enterobacter Pneumonia indication
Pseudomonas Aeruginosa Osteomyelitis indication
Serratia Complicated UTI indication
Providencia Complicated UTI indication
Pyrexia of unknown origin off-label use 7520000
Exposure keratoconjunctivitis off-label use 14366000 DOID:9461
Neuropathic corneal ulcer off-label use 231901007
Superficial Ocular Infection off-label use
Ocular hypertension contraindication 4210003 DOID:9282
Hypocalcemia contraindication 5291005
Herpes simplex keratitis contraindication 9389005
Glaucoma contraindication 23986001 DOID:1686
Herpes simplex dendritic keratitis contraindication 29943008
Fungal infection of eye contraindication 31194008
Parkinsonism contraindication 32798002
Dehydration contraindication 34095006
Severe myopia contraindication 34187009
Tuberculosis of eye contraindication 49107007
Tinnitus contraindication 60862001
Diabetes mellitus contraindication 73211009 DOID:9351
Open-angle glaucoma contraindication 84494001 DOID:1067
Krukenberg spindle contraindication 85430004
Herpes zoster ophthalmicus contraindication 87513003
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Eye infection contraindication 128351009
Bacterial infection of eye contraindication 128984004
Hypomagnesemia contraindication 190855004
Pregnancy, function contraindication 289908002
Viral eye infection contraindication 312132001
Vaccinia keratitis contraindication 397552005
Pseudomembranous enterocolitis contraindication 397683000
Vertigo contraindication 399153001
Infant Botulism contraindication
Disorder of the 8th Cranial Nerve contraindication
Tobramycin Toxicity contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.15 acidic
pKa2 13.85 acidic
pKa3 8.34 Basic
pKa4 7.59 Basic
pKa5 6.94 Basic
pKa6 6.81 Basic
pKa7 5.55 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.05%;0.3% TOBRADEX ST HARROW EYE N050818 Feb. 13, 2009 RX SUSPENSION/DROPS OPHTHALMIC 8101582 Dec. 19, 2027 USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION WHERE AN INFECTION OR RISK OF INFECTION EXISTS
0.05%;0.3% TOBRADEX ST HARROW EYE N050818 Feb. 13, 2009 RX SUSPENSION/DROPS OPHTHALMIC 7795316 Aug. 3, 2028 USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION WHERE AN INFECTION OR RISK OF INFECTION EXISTS
28MG TOBI PODHALER VIATRIS N201688 March 22, 2013 RX POWDER INHALATION 8869794 Sept. 12, 2028 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
28MG TOBI PODHALER VIATRIS N201688 March 22, 2013 RX POWDER INHALATION 10207066 Nov. 4, 2030 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.5%;0.3% LOTEPREDNOL ETABONATE AND TOBRAMYCIN ALEMBIC A217597 Dec. 10, 2025 RX SUSPENSION/DROPS OPHTHALMIC July 14, 2026 COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Heparanase Enzyme IC50 6.05 CHEMBL
Taste receptor type 2 member 20 GPCR AGONIST EC50 4.29 IUPHAR
Macrolide 2'-phosphotransferase II; Macrolide 2'-phosphotransferase II protein MphB; Macrolide 2-phosphotransferase, mph(B) Enzyme Km 5.82 WOMBAT-PK

External reference:

IDSource
4018595 VUID
N0000146911 NUI
D00063 KEGG_DRUG
49842-07-1 SECONDARY_CAS_RN
4018595 VANDF
4018596 VANDF
C0040341 UMLSCUI
CHEBI:28864 CHEBI
TOY PDB_CHEM_ID
CHEMBL1747 ChEMBL_ID
CHEMBL3989564 ChEMBL_ID
D014031 MESH_DESCRIPTOR_UI
DB00684 DRUGBANK_ID
10930 IUPHAR_LIGAND_ID
2990 INN_ID
VZ8RRZ51VK UNII
36294 PUBCHEM_CID
10627 RXNORM
1090 MMSL
182011 MMSL
2138 MMSL
5590 MMSL
5591 MMSL
5606 MMSL
d00069 MMSL
002779 NDDF
002780 NDDF
13188003 SNOMEDCT_US
373548001 SNOMEDCT_US
89695009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
TOBREX HUMAN PRESCRIPTION DRUG LABEL 1 0078-0813 OINTMENT 3 mg OPHTHALMIC NDA 16 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 0078-0876 OINTMENT 3 mg OPHTHALMIC NDA 18 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4085 SOLUTION 300 mg RESPIRATORY (INHALATION) ANDA 27 sections
TOBRAMYCIN HUMAN PRESCRIPTION DRUG LABEL 1 0409-3578 INJECTION, SOLUTION 40 mg INTRAMUSCULAR ANDA 18 sections
TOBRAMYCIN AND DEXAMETHASONE HUMAN PRESCRIPTION DRUG LABEL 2 0574-4031 SUSPENSION/ DROPS 3 mg OPHTHALMIC ANDA 18 sections
BETHKIS HUMAN PRESCRIPTION DRUG LABEL 1 10122-820 SOLUTION 300 mg RESPIRATORY (INHALATION) NDA 33 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 10544-883 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 18 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 13985-604 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 18 sections
TOBRADEX HUMAN PRESCRIPTION DRUG LABEL 2 16590-223 SUSPENSION 3 mg OPHTHALMIC NDA 19 sections
TOBRAMYCIN HUMAN PRESCRIPTION DRUG LABEL 1 16590-224 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 18 sections
TOBREX HUMAN PRESCRIPTION DRUG LABEL 1 16590-225 OINTMENT 3 mg OPHTHALMIC NDA 17 sections
Tobramycin Inhalation Solution HUMAN PRESCRIPTION DRUG LABEL 1 16714-119 INHALANT 300 mg RESPIRATORY (INHALATION) ANDA 28 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 17478-290 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 19 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 17478-340 SOLUTION 300 mg RESPIRATORY (INHALATION) ANDA 29 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 21695-203 SUSPENSION 3 mg OPHTHALMIC NDA 20 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 21695-204 SOLUTION 3 mg OPHTHALMIC ANDA 17 sections
Tobramycin and Dexamethasone HUMAN PRESCRIPTION DRUG LABEL 2 21695-416 SUSPENSION/ DROPS 3 mg OPHTHALMIC NDA 20 sections
Tobrex HUMAN PRESCRIPTION DRUG LABEL 1 21695-458 OINTMENT 3 mg OPHTHALMIC NDA 17 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 21695-628 OINTMENT 3 mg OPHTHALMIC NDA 20 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 24208-290 SOLUTION 3 mg OPHTHALMIC ANDA 16 sections
Tobramycin and Dexamethasone HUMAN PRESCRIPTION DRUG LABEL 2 24208-295 SUSPENSION/ DROPS 3 mg OPHTHALMIC ANDA 17 sections
Zylet HUMAN PRESCRIPTION DRUG LABEL 2 24208-358 SUSPENSION/ DROPS 3 mg OPHTHALMIC NDA 21 sections
Kitabis Pak HUMAN PRESCRIPTION DRUG LABEL 1 24492-850 SOLUTION 300 mg RESPIRATORY (INHALATION) NDA 30 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 33261-519 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 18 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 36000-242 INJECTION 40 mg INTRAVENOUS ANDA 21 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 36000-242 INJECTION 40 mg INTRAVENOUS ANDA 21 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 36000-244 INJECTION 40 mg INTRAVENOUS ANDA 21 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 36000-244 INJECTION 40 mg INTRAVENOUS ANDA 21 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 39822-0412 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1.20 g INTRAVENOUS ANDA 22 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 42254-187 SOLUTION 3 mg OPHTHALMIC ANDA 15 sections