tobramycin ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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) 1000 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 93 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 19.25 ยตM/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

Approvals:

DateAgencyCompanyOrphan
Feb. 18, 2019 EMA PARI PHARMA GMBH
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 1813.11 14.84 432 16371 7725 56267539
Cystic fibrosis 962.98 14.84 220 16583 3224 56272040
Hospitalisation 534.87 14.84 312 16491 74688 56200576
Pseudomonas infection 264.31 14.84 103 16700 9968 56265296
Pulmonary function test decreased 257.66 14.84 78 16725 3513 56271751
Haemoptysis 184.92 14.84 109 16694 26451 56248813
Acute kidney injury 155.11 14.84 266 16537 240497 56034767
Cough 145.37 14.84 270 16533 259691 56015573
Pneumonia 117.49 14.84 325 16478 406773 55868491
Anti-neutrophil cytoplasmic antibody positive vasculitis 110.92 14.84 38 16765 2545 56272719
Renal tubular necrosis 101.37 14.84 54 16749 10774 56264490
Bronchiectasis 98.60 14.84 54 16749 11380 56263884
Death 86.17 14.84 260 16543 341166 55934098
Forced expiratory volume decreased 82.55 14.84 36 16767 4624 56270640
Cystic fibrosis respiratory infection suppression 78.54 14.84 18 16785 266 56274998
Sputum increased 74.95 14.84 27 16776 2097 56273167
Cystic fibrosis lung 74.87 14.84 15 16788 111 56275153
Ototoxicity 73.75 14.84 23 16780 1143 56274121
Hypopyon 66.67 14.84 19 16784 690 56274574
Aplastic anaemia 65.68 14.84 38 16765 8890 56266374
Proteinuria 63.57 14.84 48 16755 17522 56257742
Corneal perforation 62.68 14.84 17 16786 513 56274751
Staphylococcal infection 58.70 14.84 64 16739 37554 56237710
Corneal oedema 57.49 14.84 20 16783 1402 56273862
Bronchospasm 57.12 14.84 43 16760 15626 56259638
Disease complication 56.66 14.84 24 16779 2871 56272393
Conjunctival hyperaemia 55.77 14.84 22 16781 2194 56273070
Tinnitus 53.79 14.84 55 16748 29987 56245277
Infection 53.72 14.84 156 16647 200050 56075214
Lung disorder 53.45 14.84 72 16731 52525 56222739
Vasculitis 52.29 14.84 40 16763 14883 56260381
Endophthalmitis 51.54 14.84 23 16780 3120 56272144
Dysphonia 49.78 14.84 62 16741 41885 56233379
Pneumonia pseudomonal 45.40 14.84 19 16784 2205 56273059
Pseudomonas test positive 45.36 14.84 14 16789 672 56274592
Drug level increased 44.67 14.84 42 16761 20683 56254581
Corneal infiltrates 44.20 14.84 10 16793 139 56275125
Off label use 43.47 14.84 299 16504 555881 55719383
Lung transplant 43.37 14.84 20 16783 2927 56272337
Systemic lupus erythematosus 42.17 14.84 3 16800 180075 56095189
Pneumothorax 39.70 14.84 34 16769 14833 56260431
Eye irritation 38.05 14.84 37 16766 18991 56256273
Drug resistance 37.48 14.84 38 16765 20504 56254760
Ulcerative keratitis 37.19 14.84 17 16786 2438 56272826
Synovitis 36.88 14.84 3 16800 161302 56113962
Dyspnoea 36.37 14.84 301 16502 592276 55682988
Acute generalised exanthematous pustulosis 35.78 14.84 27 16776 9842 56265422
Chest discomfort 35.60 14.84 86 16717 98771 56176493
Deafness 34.73 14.84 33 16770 16461 56258803
Glossodynia 34.40 14.84 3 16800 152455 56122809
SLE arthritis 33.95 14.84 11 16792 619 56274645
Burkholderia cepacia complex infection 33.53 14.84 8 16795 142 56275122
Antibiotic level above therapeutic 33.52 14.84 9 16794 261 56275003
Aphonia 33.40 14.84 25 16778 9004 56266260
Productive cough 33.27 14.84 60 16743 56172 56219092
Overlap syndrome 33.11 14.84 11 16792 670 56274594
Abdominal discomfort 33.08 14.84 21 16782 277253 55998011
Condition aggravated 32.12 14.84 194 16609 344704 55930560
Drug reaction with eosinophilia and systemic symptoms 31.56 14.84 42 16761 30262 56245002
Infective exacerbation of bronchiectasis 31.39 14.84 9 16794 334 56274930
Pain 31.36 14.84 98 16705 663086 55612178
Wound 30.60 14.84 3 16800 138801 56136463
Retinopathy of prematurity 30.39 14.84 9 16794 375 56274889
Swelling 30.22 14.84 17 16786 239754 56035510
Nephropathy toxic 30.19 14.84 23 16780 8504 56266760
Stenotrophomonas infection 29.09 14.84 13 16790 1768 56273496
Arthropathy 28.58 14.84 12 16791 200263 56075001
Ocular hyperaemia 28.52 14.84 34 16769 21945 56253319
Visual acuity reduced 28.45 14.84 33 16770 20693 56254571
Drug ineffective 27.91 14.84 161 16642 918828 55356436
Sweat test abnormal 27.75 14.84 5 16798 19 56275245
Pathogen resistance 27.67 14.84 19 16784 5981 56269283
Rheumatoid arthritis 27.44 14.84 45 16758 382559 55892705
Corneal epithelium defect 27.09 14.84 8 16795 330 56274934
Keratitis fungal 26.95 14.84 7 16796 178 56275086
Peripheral swelling 26.35 14.84 19 16784 234707 56040557
Infusion related reaction 26.06 14.84 15 16788 208916 56066348
Alopecia 25.55 14.84 30 16773 293428 55981836
Corneal neovascularisation 25.07 14.84 6 16797 108 56275156
Elbow deformity 24.96 14.84 11 16792 1448 56273816
Rhinovirus infection 24.43 14.84 15 16788 3907 56271357
Lipogranuloma 24.42 14.84 4 16799 7 56275257
Pneumonia staphylococcal 24.03 14.84 13 16790 2672 56272592
Ocular hypertension 22.87 14.84 9 16794 892 56274372
Keratitis 22.81 14.84 13 16790 2954 56272310
Vitritis 22.51 14.84 9 16794 930 56274334
Injection site pain 22.32 14.84 4 16799 117114 56158150
Bronchopulmonary aspergillosis allergic 21.86 14.84 10 16793 1436 56273828
Distal intestinal obstruction syndrome 21.76 14.84 7 16796 385 56274879
Sputum discoloured 21.73 14.84 24 16779 14268 56260996
Therapeutic product effect incomplete 21.61 14.84 3 16800 106028 56169236
Respirovirus test positive 21.48 14.84 4 16799 19 56275245
Eyelid oedema 21.44 14.84 20 16783 9748 56265516
Increased bronchial secretion 20.86 14.84 10 16793 1597 56273667
Product administered to patient of inappropriate age 20.62 14.84 12 16791 2836 56272428
Respiratory tract infection bacterial 20.21 14.84 6 16797 252 56275012
Corneal thinning 20.16 14.84 5 16798 105 56275159
Therapy cessation 19.97 14.84 32 16771 27232 56248032
Mobility decreased 19.71 14.84 3 16800 98988 56176276
Overdose 19.35 14.84 4 16799 105826 56169438
Jaw fracture 19.35 14.84 11 16792 2489 56272775
Clubbing 19.11 14.84 6 16797 305 56274959
Keratitis bacterial 18.98 14.84 4 16799 39 56275225
Fall 18.91 14.84 50 16753 357460 55917804
Bronchial wall thickening 18.02 14.84 8 16795 1072 56274192
Corneal opacity 17.83 14.84 7 16796 689 56274575
Contusion 17.83 14.84 8 16795 128422 56146842
Anterior chamber fibrin 17.79 14.84 4 16799 54 56275210
Aspergilloma 17.75 14.84 5 16798 174 56275090
Respiration abnormal 17.34 14.84 14 16789 5627 56269637
Corneal disorder 17.09 14.84 9 16794 1753 56273511
Pupillary block 16.53 14.84 3 16800 12 56275252
Spirometry abnormal 16.45 14.84 5 16798 228 56275036
Mycobacterium chelonae infection 16.37 14.84 6 16797 489 56274775
Forced expiratory volume increased 16.33 14.84 3 16800 13 56275251
Foreign body sensation in eyes 16.33 14.84 9 16794 1918 56273346
Respiratory disorder 16.11 14.84 33 16770 33924 56241340
Pancreatic failure 15.91 14.84 7 16796 918 56274346
Eye pain 15.85 14.84 31 16772 30816 56244448
Corneal erosion 15.72 14.84 5 16798 265 56274999
Blastomycosis 15.51 14.84 5 16798 277 56274987
Acinetobacter infection 15.46 14.84 8 16795 1502 56273762
Central nervous system fungal infection 15.39 14.84 4 16799 102 56275162
Discomfort 15.22 14.84 12 16791 141749 56133515
Bartter's syndrome 15.00 14.84 3 16800 22 56275242
Renal failure 14.95 14.84 69 16734 110431 56164833
Intraocular pressure increased 14.87 14.84 13 16790 5828 56269436

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 1616.65 16.99 409 14020 6075 31676840
Cystic fibrosis 960.55 16.99 214 14215 1752 31681163
Hospitalisation 433.68 16.99 274 14155 49533 31633382
Pseudomonas infection 213.29 16.99 104 14325 11297 31671618
Pulmonary function test decreased 195.53 16.99 74 14355 4311 31678604
Choroiditis 165.71 16.99 47 14382 1085 31681830
Endophthalmitis 139.74 16.99 55 14374 3561 31679354
Eye pain 138.52 16.99 80 14349 12224 31670691
Intraocular pressure increased 130.14 16.99 58 14371 5129 31677786
Ototoxicity 121.25 16.99 41 14388 1717 31681198
Haemoptysis 116.72 16.99 105 14324 32084 31650831
Cough 112.97 16.99 212 14217 134602 31548313
Visual acuity reduced 103.11 16.99 72 14357 15271 31667644
Pneumonia 98.72 16.99 355 14074 334957 31347958
Condition aggravated 98.66 16.99 225 14204 163784 31519131
Cystic fibrosis respiratory infection suppression 89.73 16.99 21 14408 217 31682698
Infection 78.89 16.99 137 14292 81794 31601121
Uveitis 78.51 16.99 45 14384 6771 31676144
Sputum discoloured 76.09 16.99 44 14385 6732 31676183
Productive cough 74.66 16.99 84 14345 33456 31649459
Forced expiratory volume decreased 70.57 16.99 32 14397 2945 31679970
Sputum increased 70.35 16.99 29 14400 2116 31680799
Disease complication 65.37 16.99 29 14400 2534 31680381
Renal tubular necrosis 65.34 16.99 54 14375 14705 31668210
Painful respiration 63.74 16.99 23 14406 1169 31681746
Aplastic anaemia 61.37 16.99 43 14386 9160 31673755
Lung disorder 52.46 16.99 69 14360 32243 31650672
Pathogen resistance 51.92 16.99 38 14391 8663 31674252
Chest injury 51.89 16.99 21 14408 1461 31681454
Bronchospasm 51.63 16.99 40 14389 9932 31672983
Lung transplant 50.41 16.99 22 14407 1848 31681067
Walking aid user 49.88 16.99 21 14408 1615 31681300
Bronchiectasis 47.27 16.99 34 14395 7546 31675369
Dyspnoea 46.76 16.99 291 14138 343188 31339727
Drug resistance 45.91 16.99 55 14374 23398 31659517
Retinopathy of prematurity 44.55 16.99 11 14418 145 31682770
Pancreatic failure 42.15 16.99 15 14414 732 31682183
Product administered to patient of inappropriate age 41.54 16.99 22 14407 2835 31680080
Linear IgA disease 40.89 16.99 18 14411 1544 31681371
Hypoacusis 39.36 16.99 41 14388 14958 31667957
Nephropathy toxic 39.08 16.99 36 14393 11317 31671598
Cystic fibrosis related diabetes 38.18 16.99 10 14419 169 31682746
Infective exacerbation of bronchiectasis 37.54 16.99 12 14417 420 31682495
Pneumonia pseudomonal 37.20 16.99 22 14407 3507 31679408
Tinnitus 36.60 16.99 41 14388 16234 31666681
Increased viscosity of bronchial secretion 36.28 16.99 10 14419 207 31682708
Mycobacterium chelonae infection 34.78 16.99 13 14416 730 31682185
Oxygen saturation decreased 34.65 16.99 72 14357 49043 31633872
Respiratory tract irritation 34.43 16.99 9 14420 151 31682764
Deafness 33.74 16.99 32 14397 10433 31672482
Cystic fibrosis lung 31.63 16.99 7 14422 55 31682860
Deafness neurosensory 31.45 16.99 18 14411 2698 31680217
Fall 30.57 16.99 24 14405 186065 31496850
Pseudomonas test positive 30.47 16.99 13 14416 1033 31681882
Vestibular disorder 30.25 16.99 13 14416 1052 31681863
Respiratory disorder 30.25 16.99 39 14390 17861 31665054
Distal intestinal obstruction syndrome 29.51 16.99 9 14420 269 31682646
Somnolence 29.31 16.99 5 14424 99440 31583475
Staphylococcal infection 27.84 16.99 50 14379 30582 31652333
Aortic aneurysm 27.25 16.99 23 14406 6442 31676473
Aphonia 27.11 16.99 17 14412 3008 31679907
Oral candidiasis 26.80 16.99 29 14400 11048 31671867
Increased bronchial secretion 26.61 16.99 14 14415 1780 31681135
Toxic epidermal necrolysis 26.13 16.99 38 14391 19486 31663429
Acute kidney injury 25.76 16.99 216 14213 279498 31403417
Influenza 25.62 16.99 60 14369 44265 31638650
Arthralgia 25.53 16.99 19 14410 151405 31531510
Ulcerative keratitis 25.23 16.99 13 14416 1583 31681332
Keratitis bacterial 24.89 16.99 6 14423 71 31682844
Wheezing 24.49 16.99 52 14377 35934 31646981
Ill-defined disorder 23.79 16.99 29 14400 12548 31670367
Death 23.59 16.99 259 14170 360310 31322605
Chronic sinusitis 23.56 16.99 13 14416 1816 31681099
Toxic anterior segment syndrome 23.25 16.99 11 14418 1114 31681801
Corneal epithelium defect 23.10 16.99 8 14421 360 31682555
Chest discomfort 21.44 16.99 60 14369 49309 31633606
Rhonchi 21.38 16.99 12 14417 1733 31681182
Product use issue 20.86 16.99 65 14364 56694 31626221
Chondritis 20.73 16.99 6 14423 149 31682766
Feeling cold 19.67 16.99 23 14406 9531 31673384
Flavobacterium infection 19.29 16.99 5 14424 81 31682834
Aspergillus infection 19.29 16.99 25 14404 11503 31671412
Anaemia 19.23 16.99 43 14386 213479 31469436
Febrile convulsion 19.17 16.99 8 14421 602 31682313
Bronchopulmonary aspergillosis allergic 18.99 16.99 8 14421 616 31682299
Ocular hyperaemia 18.81 16.99 23 14406 9986 31672929
Keratitis 18.79 16.99 10 14419 1301 31681614
Malaise 18.71 16.99 136 14293 168375 31514540
Neuralgic amyotrophy 18.47 16.99 6 14423 221 31682694
Carbon dioxide increased 18.16 16.99 9 14420 1010 31681905
Trichosporon infection 18.14 16.99 8 14421 689 31682226
Cholangitis infective 18.12 16.99 6 14423 235 31682680
Hypotony of eye 18.12 16.99 5 14424 104 31682811
Hypertension 18.06 16.99 19 14410 128081 31554834
Lipogranuloma 18.01 16.99 3 14426 3 31682912
Tracheostomy 17.68 16.99 8 14421 732 31682183
Malignant neoplasm progression 17.53 16.99 7 14422 78991 31603924
Nausea 17.19 16.99 77 14352 307870 31375045
Ocular hypertension 17.16 16.99 8 14421 784 31682131
Erythema of eyelid 17.13 16.99 8 14421 787 31682128

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 2615.06 13.87 647 24225 11511 70892061
Cystic fibrosis 1469.55 13.87 333 24539 3948 70899624
Hospitalisation 729.99 13.87 418 24454 82150 70821422
Pulmonary function test decreased 333.36 13.87 115 24757 6686 70896886
Pseudomonas infection 299.50 13.87 142 24730 18852 70884720
Haemoptysis 250.31 13.87 179 24693 51273 70852299
Renal tubular necrosis 179.74 13.87 108 24764 23063 70880509
Ototoxicity 176.82 13.87 58 24814 2883 70900689
Acute kidney injury 171.74 13.87 456 24416 474168 70429404
Endophthalmitis 157.55 13.87 65 24807 6190 70897382
Choroiditis 157.53 13.87 44 24828 1257 70902315
Intraocular pressure increased 135.55 13.87 65 24807 8836 70894736
Pneumonia 131.18 13.87 482 24390 595750 70307822
Cough 127.05 13.87 322 24550 325055 70578517
Aplastic anaemia 124.70 13.87 76 24796 16640 70886932
Cystic fibrosis respiratory infection suppression 123.35 13.87 29 24843 406 70903166
Disease complication 120.79 13.87 49 24823 4468 70899104
Visual acuity reduced 117.33 13.87 89 24783 27841 70875731
Forced expiratory volume decreased 116.22 13.87 55 24817 7259 70896313
Sputum increased 115.20 13.87 46 24826 4026 70899546
Eye pain 109.85 13.87 93 24779 34009 70869563
Bronchiectasis 102.01 13.87 66 24806 16031 70887541
Cystic fibrosis lung 98.61 13.87 20 24852 132 70903440
Death 82.26 13.87 375 24497 509686 70393886
Drug resistance 81.90 13.87 83 24789 38107 70865465
Condition aggravated 81.70 13.87 331 24541 427304 70476268
Anti-neutrophil cytoplasmic antibody positive vasculitis 78.77 13.87 33 24839 3264 70900308
Ulcerative keratitis 78.49 13.87 33 24839 3294 70900278
Tinnitus 78.26 13.87 79 24793 36097 70867475
Pathogen resistance 78.18 13.87 52 24820 13227 70890345
Corneal perforation 76.25 13.87 22 24850 708 70902864
Pneumonia pseudomonal 75.92 13.87 37 24835 5209 70898363
Sputum discoloured 74.63 13.87 58 24814 18793 70884779
Nephropathy toxic 71.21 13.87 56 24816 18458 70885114
Lung transplant 70.43 13.87 33 24839 4257 70899315
Bronchospasm 69.00 13.87 60 24812 22732 70880840
Uveitis 68.36 13.87 50 24822 14795 70888777
Productive cough 67.46 13.87 108 24764 78229 70825343
Hypopyon 67.45 13.87 22 24850 1073 70902499
Corneal oedema 63.43 13.87 26 24846 2434 70901138
Staphylococcal infection 62.39 13.87 85 24787 53319 70850253
Infective exacerbation of bronchiectasis 62.39 13.87 19 24853 739 70902833
Drug level increased 60.16 13.87 69 24803 36400 70867172
Corneal infiltrates 53.91 13.87 14 24858 301 70903271
Conjunctival hyperaemia 53.68 13.87 27 24845 4066 70899506
Lung disorder 50.75 13.87 89 24783 69395 70834177
Fall 49.15 13.87 50 24822 444046 70459526
Painful respiration 47.54 13.87 23 24849 3185 70900387
Chest injury 45.87 13.87 21 24851 2570 70901002
Aphonia 44.51 13.87 32 24840 9219 70894353
Product administered to patient of inappropriate age 43.94 13.87 25 24847 4818 70898754
Ocular hypertension 43.90 13.87 17 24855 1371 70902201
Pseudomonas test positive 43.78 13.87 18 24854 1698 70901874
Cystic fibrosis related diabetes 43.64 13.87 11 24861 209 70903363
Corneal epithelium defect 42.94 13.87 14 24858 682 70902890
Dyspnoea 42.52 13.87 434 24438 769626 70133946
Lipogranuloma 42.49 13.87 7 24865 10 70903562
Pancreatic failure 42.36 13.87 17 24855 1507 70902065
Acute generalised exanthematous pustulosis 41.57 13.87 38 24834 15359 70888213
Mycobacterium chelonae infection 41.34 13.87 19 24853 2345 70901227
Linear IgA disease 40.45 13.87 20 24852 2904 70900668
Distal intestinal obstruction syndrome 39.26 13.87 13 24859 665 70902907
Keratitis fungal 39.15 13.87 11 24861 321 70903251
Hypoacusis 39.03 13.87 48 24824 27221 70876351
Deafness 37.85 13.87 40 24832 19263 70884309
Corneal neovascularisation 36.87 13.87 9 24863 149 70903423
Deafness neurosensory 36.71 13.87 25 24847 6607 70896965
Pneumothorax 36.20 13.87 45 24827 25801 70877771
Therapeutic product effect decreased 36.08 13.87 4 24868 143014 70760558
Antibiotic level above therapeutic 35.92 13.87 12 24860 631 70902941
Corneal opacity 34.50 13.87 13 24859 973 70902599
Increased viscosity of bronchial secretion 34.49 13.87 11 24861 499 70903073
Off label use 33.28 13.87 402 24470 742658 70160914
Ocular hyperaemia 33.08 13.87 42 24830 24597 70878975
Keratitis 33.03 13.87 19 24853 3738 70899834
Infection 32.35 13.87 153 24719 210632 70692940
Pain 32.19 13.87 113 24759 628703 70274869
Bronchopulmonary aspergillosis allergic 31.87 13.87 15 24857 1954 70901618
Keratitis bacterial 31.79 13.87 8 24864 151 70903421
Increased bronchial secretion 30.87 13.87 17 24855 3076 70900496
Aortic aneurysm 30.67 13.87 24 24848 7849 70895723
Vasculitis 30.57 13.87 36 24836 19522 70884050
Injection site pain 30.41 13.87 3 24869 117616 70785956
Forced expiratory volume increased 29.93 13.87 6 24866 37 70903535
Respiratory disorder 29.71 13.87 51 24821 39072 70864500
Stenotrophomonas infection 29.61 13.87 17 24855 3332 70900240
Rhinovirus infection 29.47 13.87 22 24850 6711 70896861
Swelling 28.92 13.87 15 24857 188524 70715048
Syncope 28.84 13.87 11 24861 165698 70737874
Proteinuria 28.77 13.87 43 24829 29331 70874241
Trichosporon infection 27.68 13.87 11 24861 950 70902622
Vestibular disorder 26.65 13.87 14 24858 2306 70901266
Somnolence 26.50 13.87 22 24850 215584 70687988
Burkholderia cepacia complex infection 26.50 13.87 8 24864 302 70903270
SLE arthritis 25.91 13.87 9 24863 533 70903039
Chest discomfort 25.83 13.87 99 24773 124282 70779290
Mobility decreased 25.68 13.87 3 24869 102996 70800576
Wheezing 25.65 13.87 82 24790 94088 70809484
Toxic epidermal necrolysis 25.48 13.87 48 24824 39509 70864063
Systemic lupus erythematosus 25.32 13.87 3 24869 101899 70801673
Anaemia 25.26 13.87 66 24806 403357 70500215
Toxic anterior segment syndrome 25.01 13.87 14 24858 2616 70900956
Vitritis 24.99 13.87 12 24860 1634 70901938
Eye irritation 24.96 13.87 31 24841 17757 70885815
Clubbing 24.94 13.87 9 24863 596 70902976
Eyelid oedema 24.29 13.87 26 24846 12701 70890871
Dysphonia 24.23 13.87 54 24818 50046 70853526
Intentional overdose 24.21 13.87 3 24869 98432 70805140
Walking aid user 24.13 13.87 21 24851 7960 70895612
Overdose 23.89 13.87 15 24857 169730 70733842
Hypotony of eye 23.72 13.87 7 24865 244 70903328
Aspergillus infection 23.26 13.87 30 24842 17838 70885734
Infusion related reaction 23.25 13.87 21 24851 197513 70706059
Oxygen saturation decreased 22.82 13.87 91 24781 116338 70787234
Overlap syndrome 22.81 13.87 9 24863 763 70902809
Pneumonia staphylococcal 22.34 13.87 16 24856 4582 70898990
Arthralgia 22.18 13.87 96 24776 503294 70400278
Rheumatoid arthritis 22.12 13.87 43 24829 291762 70611810
Wound 22.01 13.87 4 24868 98728 70804844
Bronchial wall thickening 21.81 13.87 12 24860 2167 70901405
Respiratory tract irritation 21.51 13.87 8 24864 577 70902995
Arthropathy 21.48 13.87 13 24859 150044 70753528
Malignant neoplasm progression 21.32 13.87 8 24864 121731 70781841
Corneal thinning 21.26 13.87 6 24866 178 70903394
Pain in extremity 21.05 13.87 53 24819 328029 70575543
Gastrointestinal haemorrhage 20.96 13.87 11 24861 137397 70766175
Therapeutic product effect incomplete 20.79 13.87 8 24864 119874 70783698
Macular oedema 20.68 13.87 16 24856 5146 70898426
Abdominal discomfort 20.64 13.87 27 24845 214631 70688941
Respiration abnormal 20.63 13.87 18 24854 6846 70896726
Hypertension 20.44 13.87 46 24826 295987 70607585
Glossodynia 20.40 13.87 3 24869 86484 70817088
Respiratory distress 20.10 13.87 53 24819 54597 70848975
Drug reaction with eosinophilia and systemic symptoms 20.07 13.87 55 24817 57958 70845614
Flavobacterium infection 19.69 13.87 5 24867 98 70903474
Oral candidiasis 19.57 13.87 33 24839 24919 70878653
Gait disturbance 19.14 13.87 22 24850 185084 70718488
Neuralgic amyotrophy 19.01 13.87 6 24866 263 70903309
Erythema of eyelid 18.89 13.87 11 24861 2214 70901358
Respiratory tract infection bacterial 18.59 13.87 10 24862 1727 70901845
Rhonchi 18.40 13.87 13 24859 3642 70899930
Post procedural complication 18.39 13.87 30 24842 22051 70881521
Sweat test abnormal 18.34 13.87 4 24868 39 70903533
Multiple organ dysfunction syndrome 18.28 13.87 81 24791 108434 70795138
Underweight 18.13 13.87 8 24864 898 70902674
Febrile convulsion 18.07 13.87 8 24864 905 70902667
Fatigue 17.88 13.87 194 24678 824125 70079447
Haemodialysis 17.84 13.87 26 24846 17340 70886232
Influenza 17.76 13.87 83 24789 113617 70789955
Corneal erosion 17.75 13.87 6 24866 327 70903245
Pericarditis 17.70 13.87 4 24868 84701 70818871
Chondritis 17.60 13.87 5 24867 152 70903420
Restrictive cardiomyopathy 17.39 13.87 8 24864 990 70902582
Elbow deformity 17.33 13.87 9 24863 1449 70902123
Contusion 17.09 13.87 12 24860 128024 70775548
Therapy cessation 17.08 13.87 37 24835 33639 70869933
Anterior chamber fibrin 17.04 13.87 5 24867 171 70903401
Discomfort 16.74 13.87 8 24864 105428 70798144
Surgical procedure repeated 16.73 13.87 7 24865 690 70902882
Corneal disorder 16.48 13.87 10 24862 2169 70901403
Psoriasis 16.36 13.87 7 24865 98426 70805146
Pulmonary haemorrhage 16.32 13.87 22 24850 13651 70889921
Muscle spasms 16.26 13.87 18 24854 154028 70749544
Hypoaesthesia 16.19 13.87 18 24854 153721 70749851
Alopecia 16.14 13.87 28 24844 198462 70705110
Suicide attempt 16.13 13.87 4 24868 79506 70824066
Herpes zoster 15.96 13.87 5 24867 85230 70818342
Loss of consciousness 15.57 13.87 19 24853 155697 70747875
Cronobacter infection 15.50 13.87 3 24869 15 70903557
Vitamin A deficiency 15.45 13.87 4 24868 85 70903487
Mycobacterium abscessus infection 15.42 13.87 8 24864 1284 70902288
Cholangitis infective 15.20 13.87 6 24866 509 70903063
Interstitial lung disease 15.07 13.87 9 24863 104676 70798896
Vitamin E deficiency 15.04 13.87 3 24869 18 70903554
Pyrexia 14.94 13.87 297 24575 606655 70296917
Infectious crystalline keratopathy 14.90 13.87 3 24869 19 70903553
Acinetobacter infection 14.85 13.87 10 24862 2594 70900978
Scedosporium infection 14.80 13.87 8 24864 1396 70902176
Muscular weakness 14.78 13.87 16 24856 138320 70765252
Staphylococcus test positive 14.73 13.87 14 24858 5940 70897632
Carbon dioxide increased 14.49 13.87 9 24863 2036 70901536
Bacterial infection 14.47 13.87 30 24842 26462 70877110
Bartter's syndrome 14.40 13.87 3 24869 23 70903549
Renal impairment 14.35 13.87 93 24779 143844 70759728
Angle closure glaucoma 14.26 13.87 10 24862 2769 70900803
Plasma cell myeloma 14.24 13.87 4 24868 73197 70830375
Dermatitis exfoliative 14.18 13.87 18 24854 10533 70893039
Injection site erythema 14.16 13.87 4 24868 72920 70830652
Chronic sinusitis 13.95 13.87 16 24856 8435 70895137

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 D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
CHEBI has role CHEBI:27026 toxins
CHEBI has role CHEBI:33281 antibiotics
CHEBI has role CHEBI:33282 bactericides

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




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 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
300MG/4ML BETHKIS CHIESI N201820 Oct. 12, 2012 RX SOLUTION INHALATION 7939502 June 14, 2022 MANAGEMENT OF CYSTIC FIBROSIS PATIENTS
28MG TOBI PODHALER MYLAN SPECIALITY LP N201688 March 22, 2013 RX POWDER INHALATION 7368102 Dec. 19, 2022 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
28MG TOBI PODHALER MYLAN SPECIALITY LP N201688 March 22, 2013 RX POWDER INHALATION 8715623 Dec. 19, 2022 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
28MG TOBI PODHALER MYLAN SPECIALITY LP N201688 March 22, 2013 RX POWDER INHALATION 9421166 Dec. 19, 2022 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
28MG TOBI PODHALER MYLAN SPECIALITY LP N201688 March 22, 2013 RX POWDER INHALATION 8664187 June 20, 2025 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
0.05%;0.3% TOBRADEX ST EYEVANCE 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 EYEVANCE 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 MYLAN SPECIALITY LP N201688 March 22, 2013 RX POWDER INHALATION 8869794 Sept. 12, 2028 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
28MG TOBI PODHALER MYLAN SPECIALITY LP 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)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
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
CHEMBL1200780 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 0065-0643 SOLUTION/ DROPS 3 mg OPHTHALMIC NDA 17 sections
Tobrex HUMAN PRESCRIPTION DRUG LABEL 1 0065-0643 SOLUTION/ DROPS 3 mg OPHTHALMIC NDA 17 sections
TOBREX HUMAN PRESCRIPTION DRUG LABEL 1 0065-0644 OINTMENT 3 mg OPHTHALMIC NDA 16 sections
TOBREX HUMAN PRESCRIPTION DRUG LABEL 1 0065-0644 OINTMENT 3 mg OPHTHALMIC NDA 16 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 0065-0647 SUSPENSION/ DROPS 3 mg OPHTHALMIC NDA 18 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 0065-0647 SUSPENSION/ DROPS 3 mg OPHTHALMIC NDA 18 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 0065-0648 OINTMENT 3 mg OPHTHALMIC NDA 18 sections
TOBI HUMAN PRESCRIPTION DRUG LABEL 1 0078-0494 SOLUTION 300 mg ORAL NDA 30 sections
TOBI HUMAN PRESCRIPTION DRUG LABEL 1 0078-0494 SOLUTION 300 mg ORAL NDA 30 sections
TOBI Podhaler HUMAN PRESCRIPTION DRUG LABEL 1 0078-0630 CAPSULE 28 mg ORAL NDA 29 sections
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
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 0078-0876 OINTMENT 3 mg OPHTHALMIC NDA 18 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 0078-0953 SUSPENSION/ DROPS 3 mg OPHTHALMIC NDA 18 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0093-3750 SOLUTION 300 mg RESPIRATORY (INHALATION) ANDA 30 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0093-3750 SOLUTION 300 mg RESPIRATORY (INHALATION) ANDA 30 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4085 SOLUTION 300 mg RESPIRATORY (INHALATION) ANDA 26 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4085 SOLUTION 300 mg RESPIRATORY (INHALATION) ANDA 26 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0404-7196 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 18 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0409-3577 INJECTION, SOLUTION 10 mg INTRAMUSCULAR ANDA 18 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0409-3577 INJECTION, SOLUTION 10 mg INTRAMUSCULAR ANDA 18 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0409-3578 INJECTION, SOLUTION 40 mg INTRAMUSCULAR ANDA 18 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 30 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