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

Stem definitionDrug idCAS RN
antibiotics, kanamycin and bekanamycin derivatives (obtained from Streptomyces kanamyceticus) 157 37517-28-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • amikacin
  • amicacin
  • amikacillin
  • arikace
  • lukadin
  • amikacin sulfate
  • amikacin hydrate
A broad-spectrum antibiotic derived from KANAMYCIN. It is reno- and oto-toxic like the other aminoglycoside antibiotics.
  • Molecular weight: 585.61
  • Formula: C22H43N5O13
  • CLOGP: -4.12
  • LIPINSKI: 3
  • HAC: 18
  • HDO: 13
  • TPSA: 331.94
  • ALOGS: -1.07
  • ROTB: 10

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.59 g Inhal.solution
1 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 98 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 25.61 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 0 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.16 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.10 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.88 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 22, 1981 FDA APOTHECON
March 23, 2021 PMDA Insmed GK

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
Drug resistance 357.50 18.62 152 15201 22781 63450888
Dysphonia 201.97 18.62 132 15221 47482 63426187
Pathogen resistance 190.94 18.62 68 15285 6330 63467339
Septic shock 153.80 18.62 128 15225 66501 63407168
Drug reaction with eosinophilia and systemic symptoms 151.30 18.62 97 15256 33739 63439930
Deafness 146.05 18.62 76 15277 17881 63455788
Multiple organ dysfunction syndrome 145.66 18.62 116 15237 56636 63417033
Therapy interrupted 127.94 18.62 86 15267 32369 63441300
Aphonia 115.90 18.62 54 15299 10009 63463660
Ototoxicity 114.81 18.62 32 15321 1330 63472339
Off label use 105.21 18.62 379 14974 674083 62799586
Cough 103.27 18.62 222 15131 292521 63181148
Tinnitus 100.42 18.62 77 15276 35551 63438118
Thrombocytopenia 98.76 18.62 150 15203 151007 63322662
Systemic candida 91.20 18.62 33 15320 3212 63470457
Haemoptysis 89.65 18.62 66 15287 28660 63445009
Eosinophilia 86.56 18.62 59 15294 22697 63450972
Rash maculo-papular 83.51 18.62 66 15287 31830 63441839
Hospitalisation 80.48 18.62 101 15252 84980 63388689
Sputum increased 80.48 18.62 28 15325 2431 63471238
Geotrichum infection 78.23 18.62 19 15334 455 63473214
Pain 75.36 18.62 43 15310 740585 62733084
Mycobacterium abscessus infection 71.87 18.62 19 15334 645 63473024
Toxic skin eruption 70.41 18.62 42 15311 12843 63460826
Klebsiella infection 68.90 18.62 36 15317 8530 63465139
Candida infection 68.55 18.62 56 15297 28295 63445374
Pseudomonas infection 65.08 18.62 38 15315 11175 63462494
Sepsis 63.14 18.62 124 15229 152999 63320670
Paradoxical drug reaction 62.91 18.62 27 15326 4125 63469544
Bronchopulmonary aspergillosis 60.21 18.62 33 15320 8602 63465067
Hepatotoxicity 59.38 18.62 58 15295 36983 63436686
Immune reconstitution inflammatory syndrome 58.95 18.62 29 15324 6055 63467614
Pyrexia 57.27 18.62 245 15108 470233 63003436
Acute kidney injury 56.08 18.62 165 15188 263250 63210419
Nephropathy toxic 52.06 18.62 31 15322 9448 63464221
Enterococcal infection 51.99 18.62 29 15324 7819 63465850
Hepatocellular injury 51.79 18.62 47 15306 27334 63446335
Febrile neutropenia 50.12 18.62 97 15256 118352 63355317
Mycobacterium avium complex infection 49.83 18.62 21 15332 3067 63470602
Drug ineffective for unapproved indication 48.46 18.62 50 15303 34013 63439656
Hyperlactacidaemia 48.07 18.62 20 15333 2829 63470840
Infusion related reaction 47.52 18.62 3 15350 245518 63228151
Fatigue 46.99 18.62 90 15263 887938 62585731
Productive cough 45.91 18.62 66 15287 63142 63410527
Acute respiratory distress syndrome 45.69 18.62 41 15312 23493 63450176
Acute generalised exanthematous pustulosis 45.13 18.62 30 15323 11069 63462600
Joint swelling 44.73 18.62 12 15341 327654 63146015
Mucormycosis 44.58 18.62 19 15334 2852 63470817
Product packaging difficult to open 44.04 18.62 9 15344 94 63473575
Arthralgia 43.84 18.62 44 15309 569666 62904003
Intentional dose omission 43.28 18.62 26 15327 8049 63465620
Toxic epidermal necrolysis 43.11 18.62 41 15312 25293 63448376
Clostridium difficile colitis 42.26 18.62 37 15316 20532 63453137
Encephalopathy 41.61 18.62 49 15304 38571 63435098
Deafness neurosensory 40.75 18.62 21 15332 4834 63468835
Product use in unapproved indication 38.84 18.62 113 15240 178967 63294702
Fall 38.05 18.62 24 15329 392310 63081359
Osteomyelitis bacterial 37.69 18.62 9 15344 200 63473469
Aplasia 37.43 18.62 19 15334 4240 63469429
Acinetobacter infection 36.78 18.62 14 15339 1569 63472100
Product administered to patient of inappropriate age 35.97 18.62 17 15336 3251 63470418
Nosocomial infection 35.64 18.62 14 15339 1707 63471962
Alopecia 35.06 18.62 19 15334 337517 63136152
Swelling 34.13 18.62 12 15341 275366 63198303
Synovitis 34.12 18.62 3 15350 186915 63286754
Neutropenic colitis 33.75 18.62 16 15337 3079 63470590
Headache 33.56 18.62 64 15289 633177 62840492
Leukopenia 33.53 18.62 64 15289 77226 63396443
Abdominal discomfort 33.41 18.62 18 15335 320867 63152802
Nasopharyngitis 33.41 18.62 10 15343 254247 63219422
Weight increased 32.95 18.62 11 15342 260781 63212888
Dysbiosis 32.30 18.62 11 15342 895 63472774
Pancreatitis acute 31.84 18.62 36 15317 27130 63446539
Multiple-drug resistance 31.27 18.62 18 15335 5152 63468517
Cholestasis 31.14 18.62 37 15316 29397 63444272
Respiratory failure 31.02 18.62 73 15280 101785 63371884
Hepatosplenic candidiasis 30.51 18.62 8 15345 263 63473406
Hypertransaminasaemia 29.64 18.62 19 15334 6590 63467079
Hepatitis 29.55 18.62 42 15311 39746 63433923
Bronchospasm 29.46 18.62 28 15325 17252 63456417
Antithrombin III 29.13 18.62 7 15346 160 63473509
Musculoskeletal stiffness 28.75 18.62 5 15348 184613 63289056
Butterfly rash 28.42 18.62 12 15341 1761 63471908
Retinal ischaemia 28.34 18.62 8 15345 348 63473321
Angular cheilitis 27.57 18.62 9 15344 642 63473027
Glossodynia 27.52 18.62 5 15348 178871 63294798
Bacteraemia 27.48 18.62 27 15326 17321 63456348
Guillain-Barre syndrome 27.47 18.62 15 15338 3878 63469791
Overgrowth fungal 27.29 18.62 6 15347 91 63473578
Haemorrhage intracranial 27.28 18.62 24 15329 13395 63460274
Hepatic function abnormal 27.28 18.62 39 15314 37103 63436566
Coagulopathy 27.15 18.62 29 15324 20515 63453154
Myelosuppression 27.08 18.62 31 15322 23672 63449997
Herpes simplex hepatitis 27.07 18.62 8 15345 410 63473259
Drug ineffective 26.65 18.62 376 14977 1044389 62429280
Wound 26.36 18.62 4 15349 163259 63310410
Granulomatous liver disease 26.00 18.62 9 15344 769 63472900
Klebsiella bacteraemia 25.71 18.62 11 15342 1667 63472002
Chemotherapeutic drug level increased 25.06 18.62 6 15347 135 63473534
Pain in extremity 24.98 18.62 26 15327 331460 63142209
Neuropathy peripheral 24.88 18.62 72 15281 113595 63360074
Peripheral swelling 24.77 18.62 17 15336 265925 63207744
Infective pulmonary exacerbation of cystic fibrosis 24.70 18.62 19 15334 8798 63464871
Status epilepticus 24.68 18.62 24 15329 15209 63458460
Deafness permanent 24.60 18.62 4 15349 9 63473660
Dysgeusia 24.48 18.62 42 15311 46668 63427001
Hypersensitivity 24.34 18.62 21 15332 292664 63181005
Vulvovaginitis 24.26 18.62 7 15346 330 63473339
Electrocardiogram QT prolonged 24.24 18.62 48 15305 59482 63414187
Neutropenia 24.23 18.62 95 15258 174910 63298759
Cholestatic liver injury 23.98 18.62 12 15341 2598 63471071
Deafness bilateral 23.91 18.62 10 15343 1432 63472237
Aspergillus infection 23.91 18.62 18 15335 8075 63465594
Pancytopenia 23.78 18.62 64 15289 96869 63376800
Bone marrow failure 23.36 18.62 32 15321 29258 63444411
Atypical mycobacterial infection 22.96 18.62 9 15344 1091 63472578
Capillary leak syndrome 22.86 18.62 11 15342 2189 63471480
Acute hepatic failure 22.70 18.62 25 15328 18302 63455367
Throat irritation 22.62 18.62 36 15317 37611 63436058
Granulomatosis with polyangiitis 22.55 18.62 11 15342 2254 63471415
Corneal opacity 22.55 18.62 8 15345 735 63472934
Respiratory distress 22.55 18.62 34 15319 33917 63439752
Hypofibrinogenaemia 22.42 18.62 9 15344 1161 63472508
Agranulocytosis 22.41 18.62 29 15324 25105 63448564
Rhinocerebral mucormycosis 22.03 18.62 7 15346 458 63473211
Post-tussive vomiting 21.98 18.62 3 15350 0 63473669
Lower respiratory tract infection bacterial 21.87 18.62 7 15346 469 63473200
Polyneuropathy 21.81 18.62 22 15331 14567 63459102
Kussmaul respiration 21.55 18.62 6 15347 248 63473421
Anxiety 21.49 18.62 13 15340 217528 63256141
Mycobacterium chelonae infection 21.37 18.62 7 15346 505 63473164
Generalised bullous fixed drug eruption 21.16 18.62 5 15348 106 63473563
Hypertension 20.93 18.62 22 15331 279281 63194388
Muscle spasms 20.76 18.62 6 15347 156144 63317525
Back pain 20.72 18.62 20 15333 264125 63209544
Sinusitis 20.42 18.62 15 15338 226638 63247031
Cytomegalovirus infection 19.99 18.62 25 15328 20927 63452742
Purulence 19.85 18.62 9 15344 1565 63472104
Renal failure 19.75 18.62 68 15285 117584 63356085
Insomnia 19.72 18.62 14 15339 215238 63258431
Endocarditis candida 19.64 18.62 4 15349 41 63473628
Haemophagocytic lymphohistiocytosis 19.62 18.62 18 15335 10609 63463060
Drug dose omission by device 19.57 18.62 13 15340 4788 63468881
Retinal artery occlusion 19.43 18.62 9 15344 1644 63472025
Cardiac failure acute 19.29 18.62 17 15336 9506 63464163
Tinea versicolour 19.14 18.62 4 15349 47 63473622
Cryptococcosis 19.11 18.62 8 15345 1149 63472520
Pseudomonal sepsis 19.05 18.62 10 15343 2391 63471278
Fungaemia 19.04 18.62 10 15343 2393 63471276
Respiratory gas exchange disorder 18.89 18.62 6 15347 392 63473277
Vascular device infection 18.85 18.62 15 15338 7297 63466372
Febrile bone marrow aplasia 18.82 18.62 15 15338 7310 63466359
Mycobacterial infection 18.78 18.62 9 15344 1774 63471895
Weaning failure 18.70 18.62 6 15347 405 63473264

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
Drug resistance 313.15 16.61 180 16702 25747 34914302
Ototoxicity 251.29 16.61 74 16808 1843 34938206
Drug reaction with eosinophilia and systemic symptoms 171.91 16.61 136 16746 32876 34907173
Septic shock 160.03 16.61 185 16697 71649 34868400
Pathogen resistance 153.59 16.61 80 16802 9402 34930647
Rash maculo-papular 137.02 16.61 112 16770 28339 34911710
Deafness 132.64 16.61 77 16805 11188 34928861
Electrocardiogram QT prolonged 112.83 16.61 118 16764 40834 34899215
Drug ineffective 108.77 16.61 471 16411 456280 34483769
Product use in unapproved indication 101.79 16.61 194 16688 117305 34822744
Thrombocytopenia 98.05 16.61 226 16656 156021 34784028
Multiple organ dysfunction syndrome 86.37 16.61 142 16740 76424 34863625
Eosinophilia 83.98 16.61 82 16800 26140 34913909
Immune reconstitution inflammatory syndrome 82.77 16.61 52 16830 8707 34931342
Acute kidney injury 70.29 16.61 312 16570 304676 34635373
Deafness neurosensory 66.74 16.61 31 16851 2840 34937209
Toxic skin eruption 63.74 16.61 49 16833 11336 34928713
Drug ineffective for unapproved indication 62.90 16.61 67 16815 23648 34916401
Fall 61.00 16.61 12 16870 202873 34737176
Candida infection 59.73 16.61 57 16825 17658 34922391
Klebsiella infection 59.68 16.61 42 16840 8489 34931560
Fatigue 59.56 16.61 55 16827 370598 34569451
Mycobacterium chelonae infection 58.97 16.61 20 16862 795 34939254
Off label use 58.75 16.61 374 16508 419150 34520899
Hepatotoxicity 57.51 16.61 61 16821 21424 34918625
Treatment failure 53.13 16.61 87 16795 46610 34893439
Enterococcal infection 47.65 16.61 38 16844 9268 34930781
Brain abscess 46.71 16.61 25 16857 3100 34936949
Pain 45.50 16.61 21 16861 204654 34735395
Blood pressure measurement 42.34 16.61 11 16871 169 34939880
Therapy interrupted 42.28 16.61 42 16840 13655 34926394
Pseudomonas infection 42.03 16.61 40 16842 12342 34927707
Bronchospasm 40.94 16.61 37 16845 10694 34929355
Pancytopenia 38.44 16.61 117 16765 95040 34845009
Nephropathy toxic 37.75 16.61 38 16844 12550 34927499
Hepatic cytolysis 36.75 16.61 40 16842 14456 34925593
Tuberculosis of central nervous system 36.16 16.61 10 16872 197 34939852
Deafness bilateral 35.46 16.61 15 16867 1099 34938950
Myelosuppression 35.27 16.61 45 16837 19220 34920829
Bronchopulmonary aspergillosis 34.66 16.61 39 16843 14620 34925429
Hypoacusis 34.56 16.61 41 16841 16260 34923789
Acute respiratory distress syndrome 33.13 16.61 51 16831 25918 34914131
Febrile bone marrow aplasia 32.69 16.61 29 16853 8180 34931869
Hydrocephalus 32.57 16.61 24 16858 5208 34934841
Systemic candida 32.41 16.61 21 16861 3705 34936344
Vascular pseudoaneurysm thrombosis 32.05 16.61 7 16875 48 34940001
Aspergillus infection 31.39 16.61 34 16848 12220 34927829
Nocardiosis 31.29 16.61 21 16861 3930 34936119
Hypertransaminasaemia 31.09 16.61 24 16858 5582 34934467
Myocardial infarction 30.89 16.61 10 16872 121075 34818974
Multiple-drug resistance 30.31 16.61 23 16859 5216 34934833
Linear IgA disease 30.04 16.61 15 16867 1611 34938438
Mucormycosis 29.86 16.61 24 16858 5918 34934131
Posterior reversible encephalopathy syndrome 29.76 16.61 30 16852 9924 34930125
Acute generalised exanthematous pustulosis 29.12 16.61 25 16857 6751 34933298
Stenotrophomonas infection 29.09 16.61 16 16866 2094 34937955
Sepsis neonatal 29.05 16.61 9 16873 267 34939782
Hepatocellular injury 28.86 16.61 44 16838 22167 34917882
Acoustic neuroma 28.81 16.61 8 16874 160 34939889
Headache 28.47 16.61 33 16849 200602 34739447
Fusarium infection 28.44 16.61 13 16869 1147 34938902
Cholestasis 27.70 16.61 48 16834 26900 34913149
Trichosporon infection 27.14 16.61 11 16871 723 34939326
Inflammatory marker increased 26.74 16.61 21 16861 5007 34935042
Hypofibrinogenaemia 26.64 16.61 14 16868 1672 34938377
Thalamic infarction 26.48 16.61 11 16871 770 34939279
Respiratory distress 26.12 16.61 55 16827 35610 34904439
Necrotising colitis 26.07 16.61 12 16870 1076 34938973
Incision site pain 25.51 16.61 14 16868 1824 34938225
Sepsis 25.32 16.61 152 16730 166409 34773640
Myasthenia gravis crisis 25.28 16.61 10 16872 617 34939432
Agranulocytosis 25.23 16.61 43 16839 23778 34916271
Scedosporium infection 25.19 16.61 11 16871 871 34939178
Hyperbilirubinaemia 24.23 16.61 35 16847 16808 34923241
Candida sepsis 24.22 16.61 12 16870 1267 34938782
Leukopenia 24.17 16.61 76 16806 62780 34877269
Cardiac valve vegetation 23.97 16.61 9 16873 482 34939567
Disseminated intravascular coagulation 23.93 16.61 40 16842 21776 34918273
Red blood cells urine positive 22.98 16.61 13 16869 1796 34938253
Weight bearing difficulty 22.92 16.61 11 16871 1084 34938965
Condition aggravated 22.90 16.61 165 16717 192031 34748018
Cardiac failure congestive 22.83 16.61 6 16876 83264 34856785
Vestibular disorder 22.80 16.61 11 16871 1096 34938953
Dehydration 22.34 16.61 18 16864 129951 34810098
Tuberculosis 22.32 16.61 24 16858 8553 34931496
Sputum increased 22.21 16.61 14 16868 2356 34937693
Nervous system disorder 22.07 16.61 31 16851 14512 34925537
Protein urine present 21.88 16.61 19 16863 5209 34934840
Respiratory failure 21.84 16.61 107 16775 108465 34831584
Benign soft tissue neoplasm 21.80 16.61 6 16876 116 34939933
Cerebrovascular accident 21.63 16.61 7 16875 84804 34855245
Death 21.60 16.61 109 16773 397940 34542109
Urinary tract infection fungal 20.88 16.61 8 16874 453 34939596
Candida pneumonia 20.81 16.61 8 16874 457 34939592
Back pain 20.77 16.61 17 16865 121772 34818277
Dizziness 20.62 16.61 47 16835 218474 34721575
Drug-induced liver injury 20.58 16.61 44 16838 28788 34911261
Pyrexia 20.47 16.61 248 16634 332765 34607284
Sputum purulent 20.31 16.61 8 16874 488 34939561
Product administered to patient of inappropriate age 20.27 16.61 15 16867 3276 34936773
Premature baby death 19.91 16.61 3 16879 0 34940049
Herpes zoster meningoencephalitis 19.79 16.61 7 16875 316 34939733
Mycobacterium abscessus infection 19.59 16.61 8 16874 536 34939513
Allodynia 19.40 16.61 9 16873 822 34939227
Toxic neuropathy 19.38 16.61 8 16874 551 34939498
Purpura non-thrombocytopenic 19.36 16.61 5 16877 75 34939974
Pericarditis tuberculous 19.23 16.61 5 16877 77 34939972
Malaise 19.17 16.61 38 16844 185787 34754262
Hepatitis fulminant 19.11 16.61 16 16866 4174 34935875
Arthralgia 19.11 16.61 33 16849 170008 34770041
Lymphocyte count decreased 19.08 16.61 37 16845 22585 34917464
Acinetobacter infection 19.01 16.61 10 16872 1197 34938852
Flavobacterium infection 19.00 16.61 5 16877 81 34939968
Clostridium difficile colitis 18.82 16.61 30 16852 15700 34924349
Fungaemia 18.79 16.61 13 16869 2555 34937494
Atypical mycobacterial infection 18.78 16.61 9 16873 884 34939165
Gallstone ileus 18.77 16.61 4 16878 24 34940025
Immune effector cell-associated neurotoxicity syndrome 18.66 16.61 15 16867 3698 34936351
Atypical mycobacterium test positive 18.50 16.61 4 16878 26 34940023
Pulmonary cavitation 18.43 16.61 9 16873 921 34939128
General physical condition abnormal 18.36 16.61 15 16867 3784 34936265
Inappropriate schedule of product administration 18.03 16.61 4 16878 62292 34877757
Hypersensitivity vasculitis 17.89 16.61 14 16868 3321 34936728
Pain in extremity 17.72 16.61 21 16861 126492 34813557
Hypertension 17.71 16.61 24 16858 136419 34803630
Renal tubular disorder 17.69 16.61 16 16866 4627 34935422
Hepatosplenic candidiasis 17.65 16.61 6 16876 240 34939809
Infective pulmonary exacerbation of cystic fibrosis 17.64 16.61 19 16863 6782 34933267
Shock 17.37 16.61 37 16845 24142 34915907
Vasculitis 17.02 16.61 24 16858 11272 34928777
Peripheral swelling 16.75 16.61 8 16874 76533 34863516
Haemorrhagic pneumonia 16.73 16.61 5 16877 131 34939918
Blood pressure increased 16.70 16.61 11 16871 88091 34851958
Antibiotic associated colitis 16.62 16.61 3 16879 6 34940043

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
Drug resistance 570.04 16.65 284 27788 41929 79674387
Drug reaction with eosinophilia and systemic symptoms 340.90 16.65 236 27836 64008 79652308
Ototoxicity 338.74 16.65 98 27974 3176 79713140
Pathogen resistance 313.98 16.65 135 27937 14207 79702109
Septic shock 289.23 16.65 281 27791 122520 79593796
Rash maculo-papular 227.04 16.65 175 27897 55903 79660413
Deafness 216.30 16.65 118 27954 20919 79695397
Multiple organ dysfunction syndrome 210.81 16.65 235 27837 120011 79596305
Thrombocytopenia 186.09 16.65 334 27738 264925 79451391
Eosinophilia 169.44 16.65 135 27937 45210 79671106
Drug ineffective 146.79 16.65 757 27315 1080156 78636160
Toxic skin eruption 137.53 16.65 90 27982 22203 79694113
Electrocardiogram QT prolonged 137.06 16.65 164 27908 90222 79626094
Acute kidney injury 131.31 16.65 441 27631 518963 79197353
Immune reconstitution inflammatory syndrome 129.56 16.65 73 27999 13768 79702548
Klebsiella infection 128.73 16.65 76 27996 15644 79700672
Fatigue 120.81 16.65 91 27981 929636 78786680
Hepatotoxicity 116.03 16.65 115 27957 51237 79665079
Pain 112.16 16.65 54 28018 703748 79012568
Product use in unapproved indication 112.12 16.65 262 27810 250097 79466219
Off label use 108.95 16.65 615 27457 906600 78809716
Deafness neurosensory 103.71 16.65 50 28022 6848 79709468
Enterococcal infection 100.95 16.65 65 28007 15595 79700721
Pseudomonas infection 99.65 16.65 72 28000 20831 79695485
Candida infection 92.72 16.65 89 27983 38125 79678191
Fall 91.45 16.65 29 28043 487600 79228716
Bronchopulmonary aspergillosis 91.09 16.65 70 28002 22224 79694092
Drug ineffective for unapproved indication 84.33 16.65 97 27975 51141 79665175
Sepsis 80.86 16.65 243 27829 269185 79447131
Geotrichum infection 78.15 16.65 24 28048 957 79715359
Acute respiratory distress syndrome 76.89 16.65 86 27986 43981 79672335
Headache 74.93 16.65 72 28000 653700 79062616
Mucormycosis 74.77 16.65 43 28029 8426 79707890
Nephropathy toxic 74.55 16.65 60 28012 20359 79695957
Pyrexia 72.71 16.65 447 27625 678262 79038054
Acute generalised exanthematous pustulosis 70.10 16.65 54 28018 17200 79699116
Tinnitus 69.73 16.65 82 27990 44251 79672065
Mycobacterium abscessus infection 68.96 16.65 23 28049 1199 79715117
Arthralgia 66.63 16.65 62 28010 571741 79144575
Myelosuppression 65.82 16.65 76 27996 40220 79676096
Sputum increased 65.03 16.65 32 28040 4581 79711735
Paradoxical drug reaction 64.82 16.65 37 28035 7148 79709168
Hepatocellular injury 61.90 16.65 80 27992 47513 79668803
Joint swelling 60.00 16.65 14 28058 288632 79427684
Mycobacterium chelonae infection 59.99 16.65 25 28047 2431 79713885
Dysphonia 59.45 16.65 86 27986 56786 79659530
Deafness bilateral 59.35 16.65 24 28048 2161 79714155
Multiple-drug resistance 57.86 16.65 37 28035 8771 79707545
Pancytopenia 54.95 16.65 155 27917 165590 79550726
Acinetobacter infection 53.81 16.65 24 28048 2753 79713563
Febrile bone marrow aplasia 53.44 16.65 41 28031 12979 79703337
Hypertransaminasaemia 52.15 16.65 39 28033 11885 79704431
Mycobacterium avium complex infection 50.60 16.65 27 28045 4573 79711743
Nocardiosis 50.58 16.65 29 28043 5650 79710666
Respiratory failure 50.33 16.65 159 27913 180752 79535564
Therapy interrupted 49.33 16.65 58 28014 31283 79685033
Weight increased 49.32 16.65 18 28054 277368 79438948
Aphonia 47.96 16.65 35 28037 10277 79706039
Nasopharyngitis 47.70 16.65 15 28057 253866 79462450
Aspergillus infection 47.17 16.65 45 28027 19116 79697200
Pain in extremity 46.72 16.65 36 28036 364502 79351814
Therapeutic product effect decreased 45.87 16.65 3 28069 163860 79552456
Leukopenia 45.71 16.65 116 27956 116397 79599919
Hydrocephalus 45.51 16.65 32 28040 8868 79707448
Agranulocytosis 45.47 16.65 67 28005 44963 79671353
Hepatosplenic candidiasis 45.21 16.65 14 28058 574 79715742
Clostridium difficile colitis 44.71 16.65 56 28016 32227 79684089
Respiratory distress 44.04 16.65 76 27996 58263 79658053
Nosocomial infection 44.00 16.65 21 28051 2811 79713505
Neuropathy peripheral 43.79 16.65 129 27943 141176 79575140
Hyperlactacidaemia 43.07 16.65 26 28046 5569 79710747
Infusion related reaction 42.55 16.65 14 28058 230223 79486093
Peripheral swelling 42.33 16.65 21 28051 269596 79446720
Malaise 42.30 16.65 67 28005 489802 79226514
Aplasia 42.05 16.65 29 28043 7791 79708525
Hypoacusis 41.28 16.65 52 28020 30098 79686218
Anxiety 41.11 16.65 18 28054 248494 79467822
Hypofibrinogenaemia 41.04 16.65 18 28054 1984 79714332
Cholestasis 40.80 16.65 69 28003 52040 79664276
Neutropenic colitis 40.05 16.65 25 28047 5682 79710634
Hypertension 39.54 16.65 35 28037 330957 79385359
Alopecia 39.48 16.65 16 28056 231339 79484977
Osteomyelitis bacterial 39.28 16.65 12 28060 470 79715846
Pancreatitis acute 39.26 16.65 66 28006 49538 79666778
Infective pulmonary exacerbation of cystic fibrosis 39.12 16.65 34 28038 12817 79703499
Toxic epidermal necrolysis 38.91 16.65 62 28010 44519 79671797
Synovitis 38.76 16.65 4 28068 150730 79565586
Systemic candida 38.75 16.65 26 28046 6680 79709636
Polyneuropathy 38.51 16.65 45 28027 24106 79692210
Guillain-Barre syndrome 38.49 16.65 29 28043 8936 79707380
Contusion 38.13 16.65 4 28068 148772 79567544
Inflammatory marker increased 38.02 16.65 31 28041 10709 79705607
Bronchospasm 37.46 16.65 45 28027 24814 79691502
Musculoskeletal stiffness 37.33 16.65 8 28064 175000 79541316
Haemoptysis 37.20 16.65 69 28003 55930 79660386
Haemophagocytic lymphohistiocytosis 37.03 16.65 42 28030 21795 79694521
Swelling 36.96 16.65 15 28057 216696 79499620
Atypical mycobacterial infection 36.79 16.65 16 28056 1727 79714589
Neutropenia 36.18 16.65 198 27874 287512 79428804
Hepatic cytolysis 35.86 16.65 46 28026 27105 79689211
Abdominal discomfort 35.78 16.65 22 28050 250705 79465611
Blood pressure measurement 35.73 16.65 11 28061 442 79715874
Stenotrophomonas infection 35.57 16.65 20 28052 3753 79712563
Dizziness 35.04 16.65 84 27988 526357 79189959
Product packaging difficult to open 34.92 16.65 7 28065 43 79716273
Back pain 34.17 16.65 34 28038 304146 79412170
Posterior reversible encephalopathy syndrome 33.89 16.65 44 28028 26237 79690079
Treatment failure 33.75 16.65 134 27938 170352 79545964
Vascular pseudoaneurysm thrombosis 33.53 16.65 7 28065 54 79716262
Discomfort 33.18 16.65 3 28069 125614 79590702
Brain abscess 33.08 16.65 21 28051 4915 79711401
Coagulopathy 32.70 16.65 51 28021 35955 79680361
Dehydration 32.43 16.65 24 28048 248163 79468153
Blood pressure increased 32.37 16.65 17 28055 211343 79504973
Hepatitis fulminant 32.31 16.65 24 28048 7238 79709078
Incision site pain 32.23 16.65 17 28055 2813 79713503
Immune effector cell-associated neurotoxicity syndrome 32.18 16.65 22 28050 5826 79710490
Fungaemia 31.94 16.65 20 28052 4571 79711745
Febrile neutropenia 31.79 16.65 163 27909 230836 79485480
Sinusitis 31.02 16.65 15 28057 195486 79520830
Myocardial infarction 30.98 16.65 13 28059 184116 79532200
Tuberculosis of central nervous system 30.71 16.65 10 28062 483 79715833
Gait disturbance 29.89 16.65 18 28054 207488 79508828
Leukocytosis 28.18 16.65 53 28019 43402 79672914
Linear IgA disease 27.91 16.65 16 28056 3116 79713200
Wound 27.62 16.65 4 28068 116175 79600141
Thalamic infarction 27.60 16.65 12 28060 1295 79715021
Serratia infection 27.08 16.65 13 28059 1763 79714553
Renal failure 27.08 16.65 141 27931 200827 79515489
Corneal opacity 27.01 16.65 11 28061 1009 79715307
Muscle spasms 26.83 16.65 14 28058 174716 79541600
Otitis media fungal 26.53 16.65 5 28067 21 79716295
Herpes zoster meningoencephalitis 26.47 16.65 10 28062 751 79715565
Acoustic neuroma 26.44 16.65 8 28064 303 79716013
Encephalopathy 26.32 16.65 67 28005 67330 79648986
Gastrooesophageal reflux disease 26.21 16.65 3 28069 104243 79612073
Scedosporium infection 26.18 16.65 12 28060 1466 79714850
Myasthenia gravis crisis 26.10 16.65 11 28061 1100 79715216
Depression 25.78 16.65 23 28049 216767 79499549
Red blood cells urine positive 25.74 16.65 18 28054 4945 79711371
Renal tubular disorder 25.69 16.65 20 28052 6466 79709850
Immune reconstitution inflammatory syndrome associated tuberculosis 25.55 16.65 10 28062 826 79715490
Tuberculosis 25.38 16.65 29 28043 15169 79701147
Protein urine present 25.37 16.65 24 28048 10088 79706228
Bacteraemia 25.08 16.65 43 28029 32781 79683535
Staphylococcal infection 24.92 16.65 60 28012 58235 79658081
Pulmonary cavitation 24.88 16.65 12 28060 1644 79714672
Overgrowth fungal 24.75 16.65 6 28066 96 79716220
Escherichia infection 24.54 16.65 31 28041 17986 79698330
Feeling abnormal 24.08 16.65 13 28059 159186 79557130
Dermatitis exfoliative 23.98 16.65 24 28048 10805 79705511
Granulomatosis with polyangiitis 23.82 16.65 14 28058 2856 79713460
Trichosporon infection 23.74 16.65 10 28062 998 79715318
Lower respiratory tract infection 23.61 16.65 8 28064 129212 79587104
Disseminated intravascular coagulation 23.60 16.65 44 28028 35798 79680518
Status epilepticus 23.48 16.65 36 28036 25005 79691311
Lung disorder 23.48 16.65 72 28000 80485 79635831
Hypersensitivity 23.43 16.65 35 28037 262204 79454112
Bone marrow failure 23.37 16.65 54 28018 51053 79665263
Benign soft tissue neoplasm 23.21 16.65 6 28066 126 79716190
Constipation 23.20 16.65 40 28032 283010 79433306
Inappropriate schedule of product administration 23.18 16.65 9 28063 133619 79582697
Rash pustular 23.10 16.65 24 28048 11287 79705029
Deafness permanent 23.10 16.65 4 28068 9 79716307
Cerebrovascular accident 23.03 16.65 13 28059 155279 79561037
Candida sepsis 22.83 16.65 13 28059 2500 79713816
Pneumonia bacterial 22.82 16.65 31 28041 19300 79697016
Blood urea increased 22.80 16.65 52 28020 48738 79667578
Retinal ischaemia 22.60 16.65 9 28063 779 79715537
Hepatitis 22.38 16.65 56 28016 55671 79660645
Vulvovaginitis 22.35 16.65 7 28065 298 79716018
Anuria 22.34 16.65 32 28040 20931 79695385
Pulmonary tuberculosis 22.32 16.65 20 28052 7845 79708471
Capillary leak syndrome 22.16 16.65 15 28057 3910 79712406
Memory impairment 22.07 16.65 6 28066 111728 79604588
Drug-induced liver injury 22.05 16.65 62 28010 66055 79650261
Herpes simplex hepatitis 22.04 16.65 8 28064 537 79715779
Dermatitis bullous 21.81 16.65 26 28046 14219 79702097
Haemolytic anaemia 21.68 16.65 29 28043 17791 79698525
Face oedema 21.68 16.65 37 28035 28099 79688217
Butterfly rash 21.65 16.65 11 28061 1685 79714631
Pneumothorax 21.50 16.65 37 28035 28286 79688030
Glossodynia 21.47 16.65 5 28067 103332 79612984
Cardiac valve vegetation 21.26 16.65 9 28063 910 79715406
Granulomatous liver disease 21.06 16.65 10 28062 1323 79714993
Shock 21.00 16.65 47 28025 43501 79672815
Cardiac failure congestive 21.00 16.65 12 28060 142390 79573926
Impaired healing 20.88 16.65 3 28069 87652 79628664
Haemoperitoneum 20.79 16.65 15 28057 4328 79711988
Toxic neuropathy 20.70 16.65 9 28063 971 79715345
Mycobacterial infection 20.66 16.65 14 28058 3654 79712662
Klebsiella bacteraemia 20.65 16.65 13 28059 2997 79713319
Hypoalbuminaemia 20.51 16.65 31 28041 21266 79695050
Gallstone ileus 20.33 16.65 4 28068 22 79716294
Mycobacterium fortuitum infection 20.18 16.65 6 28066 214 79716102
Hyperbilirubinaemia 19.90 16.65 33 28039 24485 79691831
Transaminases increased 19.74 16.65 51 28021 51692 79664624
Flavobacterium infection 19.67 16.65 5 28067 98 79716218
Drug hypersensitivity 19.61 16.65 48 28024 298868 79417448
Angular cheilitis 19.43 16.65 8 28064 754 79715562
Urogenital infection bacterial 19.39 16.65 5 28067 104 79716212
Hospitalisation 19.39 16.65 75 27997 94161 79622155
Pericarditis tuberculous 19.30 16.65 5 28067 106 79716210
Clostridial infection 19.20 16.65 16 28056 5698 79710618
Deafness unilateral 19.14 16.65 14 28058 4124 79712192
Syncope 19.08 16.65 21 28051 179428 79536888
Allodynia 19.05 16.65 10 28062 1638 79714678
Nervous system disorder 18.98 16.65 34 28038 26822 79689494
Insomnia 18.87 16.65 36 28036 245134 79471182
Migraine 18.65 16.65 4 28068 87489 79628827
Haemorrhagic pneumonia 18.18 16.65 5 28067 134 79716182
Fusarium infection 18.06 16.65 10 28062 1822 79714494
Choroiditis 17.75 16.65 9 28063 1372 79714944
Haemodynamic instability 17.74 16.65 26 28046 17356 79698960
Asthma 17.72 16.65 13 28059 135082 79581234
Injury 17.67 16.65 3 28069 77493 79638823
Cough 17.62 16.65 202 27870 366587 79349729
Product administered to patient of inappropriate age 17.52 16.65 15 28057 5538 79710778
Chemotherapeutic drug level increased 17.32 16.65 6 28066 351 79715965
Alanine aminotransferase increased 17.23 16.65 107 27965 162463 79553853
Mobility decreased 17.03 16.65 11 28061 122164 79594152
Acid fast bacilli infection 17.02 16.65 5 28067 171 79716145
Urinary tract infection fungal 16.95 16.65 8 28064 1045 79715271
Cholestatic liver injury 16.94 16.65 14 28058 4927 79711389
Rhinocerebral mucormycosis 16.91 16.65 8 28064 1050 79715266
AIDS related complication 16.87 16.65 4 28068 58 79716258
Fungal infection 16.81 16.65 42 28030 41706 79674610
Pneumonia pseudomonal 16.71 16.65 15 28057 5896 79710420

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D06AX12 DERMATOLOGICALS
ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
ANTIBIOTICS FOR TOPICAL USE
Other antibiotics for topical use
ATC J01GB06 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
AMINOGLYCOSIDE ANTIBACTERIALS
Other aminoglycosides
ATC J01RA06 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
ATC S01AA21 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFECTIVES
Antibiotics
FDA CS M0000946 Aminoglycosides
FDA EPC N0000175477 Aminoglycoside Antibacterial
CHEBI has role CHEBI:33281 antibiotics
CHEBI has role CHEBI:36047 antibacterial drugs
CHEBI has role CHEBI:61015 nephrotoxins
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents

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
Infection due to Pseudomonas aeruginosa indication 11218009
Staphylococcal meningitis indication 12166008
Infection of skin AND/OR subcutaneous tissue indication 19824006
Staphylococcal pneumonia indication 22754005
Pneumonia due to Pseudomonas indication 41381004
Pneumonia due to Escherichia coli indication 51530003
Bacterial pneumonia indication 53084003 DOID:874
Osteomyelitis indication 60168000
Infection due to Escherichia coli indication 71057007
Bacterial infection due to Serratia indication 71120004
Rhinoscleroma indication 72409005 DOID:11336
Septicemia due to Serratia indication 82091000
Cholangitis indication 82403002 DOID:9446
Bacterial meningitis indication 95883001 DOID:9470
Infection of bone indication 111253001
Staphylococcal septicemia indication 111821004
Infectious disease of abdomen indication 128070006
Infection due to Enterobacteriaceae indication 128945009
Bacterial infection due to Klebsiella pneumoniae indication 186435004
Escherichia coli meningitis indication 192655005
Proteus pneumonia indication 195888009
Sepsis of the newborn indication 206376005
Neonatal pneumonia indication 233619008
Diverticulitis of gastrointestinal tract indication 271366000
Neonatal meningitis indication 276674008
Nontuberculous mycobacterial pulmonary disease caused by amikacin-sensitive Mycobacteriumavium complex indication 277869007
Proteus septicemia indication 300986008
Escherichia coli urinary tract infection indication 301011002
Proteus meningitis indication 302877009
Bacterial urinary infection indication 312124009
Infectious disorder of joint indication 363162000
Meningitis due to Klebsiella mobilis indication 420585007
Nosocomial pneumonia indication 425464007
Bacterial meningitis due to Gram-negative bacteria indication 425887005
Pneumonia due to Gram negative bacteria indication 430395005
Sepsis due to Pseudomonas indication 448813005
Sepsis due to Gram negative bacteria indication 449082003
Urinary tract infection caused by Klebsiella indication 369001000119100
Skin and Skin Structure Pseudomonas Aeruginosa Infection indication
Pseudomonas Aeruginosa Osteomyelitis indication
Skin and Skin Structure Proteus Infection indication
Pseudomonas Aeruginosa Meningitis indication
Serratia Meningitis indication
Complicated UTI with Pseudomonas Aeruginosa indication
Complicated Urinary Tract Infections indication
Klebsiella Septicemia indication
Skin and Skin Structure Staphylococcus Infection indication
Enterobacter Meningitis indication
Burn Wound Infections indication
Pseudomonas Aeruginosa Biliary Tract Infection indication
Gram-Negative Aerobic Bacillary Pneumonia indication
Complicated Bacterial Peritonitis indication
Complicated Proteus UTI indication
Complicated Urinary Tract Infection due to Acinetobacter indication
Pseudomonas Aeruginosa Joint Infection indication
Serratia Osteomyelitis indication
Serratia Complicated UTI indication
Enterobacter Pneumonia indication
Skin and Skin Structure Serratia Infection indication
Necrotizing enterocolitis in fetus OR newborn off-label use 2707005
Pyrexia of unknown origin off-label use 7520000
Enteric campylobacteriosis off-label use 18081009
Acute tuberculosis off-label use 25629007
Pseudotuberculosis off-label use 36753006
Infection by Yersinia enterocolitica off-label use 80960004
Pulmonary tuberculosis off-label use 154283005 DOID:2957
Synergy for Group B Streptococcal Septicemia off-label use
Citrobacter Osteomyelitis off-label use
Synergy for Nosocomial Pneumonia due to Pseudomonas Aeruginosa off-label use
Citrobacter Septicemia off-label use
Citrobacter Complicated UTI off-label use
Listeria Monocytogenes Septicemia off-label use
Skin and Skin Structure Citrobacter Infection off-label use
Synergy for P. Aeruginosa Infection in Cystic Fibrosis off-label use
Synergy for Neonatal Meningitis off-label use
Citrobacter Meningitis off-label use
Synergy for Bacterial Meningitis off-label use
Citrobacter Pneumonia off-label use
Synergy for Staphylococcal Infections off-label use
Synergy for Staphylococcal Endocarditis off-label use
Skin and Skin Structure Acinetobacter Infection off-label use
Hypocalcemia contraindication 5291005
Parkinsonism contraindication 32798002
Dehydration contraindication 34095006
Tinnitus contraindication 60862001
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Pregnancy, function contraindication 289908002
Vertigo contraindication 399153001
Disorder of the 8th Cranial Nerve contraindication
Infant Botulism contraindication
Amikacin Toxicity contraindication




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Dogs Genitourinary tract infections caused by Escherichia coli Indication
Dogs Genitourinary tract infections caused by Proteus species Indication
Dogs Skin and soft tissue infections caused by Pseudomonas species Indication
Dogs Skin and soft tissue infections caused by Escherichia coli Indication
Horses Genital tract infections caused by Escherichia coli Indication
Horses Genital tract infections caused by Pseudomonas species Indication
Horses Genital tract infections caused by Klebsiella species Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Amiglyde-V Zoetis Inc. 1
Amikacin Sulfate Injection Cronus Pharma Specialities India Private Limited 1
AmiMax E Solution Elanco US Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.04 acidic
pKa2 12.95 acidic
pKa3 13.39 acidic
pKa4 13.72 acidic
pKa5 9.4 Basic
pKa6 7.84 Basic
pKa7 7.41 Basic
pKa8 6.86 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 590MG BASE/8.4ML ARIKAYCE KIT INSMED INC N207356 Sept. 28, 2018 RX SUSPENSION, LIPOSOMAL INHALATION 8802137 April 8, 2024 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN
EQ 590MG BASE/8.4ML ARIKAYCE KIT INSMED INC N207356 Sept. 28, 2018 RX SUSPENSION, LIPOSOMAL INHALATION 9827317 April 8, 2024 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
EQ 590MG BASE/8.4ML ARIKAYCE KIT INSMED INC N207356 Sept. 28, 2018 RX SUSPENSION, LIPOSOMAL INHALATION 7718189 June 6, 2025 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
EQ 590MG BASE/8.4ML ARIKAYCE KIT INSMED INC N207356 Sept. 28, 2018 RX SUSPENSION, LIPOSOMAL INHALATION 8632804 Dec. 5, 2026 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS WITH CYSTIC FIBROSIS AS PART OF A COMBINATION DRUG REGIMEN
EQ 590MG BASE/8.4ML ARIKAYCE KIT INSMED INC N207356 Sept. 28, 2018 RX SUSPENSION, LIPOSOMAL INHALATION 8679532 Dec. 5, 2026 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
EQ 590MG BASE/8.4ML ARIKAYCE KIT INSMED INC N207356 Sept. 28, 2018 RX SUSPENSION, LIPOSOMAL INHALATION 9566234 Jan. 18, 2034 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
EQ 590MG BASE/8.4ML ARIKAYCE KIT INSMED INC N207356 Sept. 28, 2018 RX SUSPENSION, LIPOSOMAL INHALATION 10251900 May 15, 2035 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN
EQ 590MG BASE/8.4ML ARIKAYCE KIT INSMED INC N207356 Sept. 28, 2018 RX SUSPENSION, LIPOSOMAL INHALATION 10751355 May 15, 2035 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN
EQ 590MG BASE/8.4ML ARIKAYCE KIT INSMED INC N207356 Sept. 28, 2018 RX SUSPENSION, LIPOSOMAL INHALATION 11446318 May 15, 2035 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN
EQ 590MG BASE/8.4ML ARIKAYCE KIT INSMED INC N207356 Sept. 28, 2018 RX SUSPENSION, LIPOSOMAL INHALATION 9895385 May 15, 2035 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN NON-CYSTIC FIBROSIS ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 590MG BASE/8.4ML ARIKAYCE KIT INSMED INC N207356 Sept. 28, 2018 RX SUSPENSION, LIPOSOMAL INHALATION Sept. 28, 2025 TX OF MAC LUNG DISEASE IN ADULTS WITH LIMITED OR NO ALTERNATIVE TX OPTIONS AS PART OF A COMBO ANTIBACTERIAL DRUG REGIMEN WHO DO NOT ACHIEVE NEGATIVE SPUTUM CULTURES AFTER A MINIMUM OF 6 CONSECUTIVE MONTHS OF A MULTIDRUG BACKGROUND REGIMEN THERAPY
EQ 590MG BASE/8.4ML ARIKAYCE KIT INSMED INC N207356 Sept. 28, 2018 RX SUSPENSION, LIPOSOMAL INHALATION Sept. 28, 2030 GENERATING ANTIBIOTIC INCENTIVES NOW

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 4.20 WOMBAT-PK

External reference:

IDSource
4019602 VUID
N0000147698 NUI
D00865 KEGG_DRUG
39831-55-5 SECONDARY_CAS_RN
641 RXNORM
C0002499 UMLSCUI
CHEBI:2637 CHEBI
AKN PDB_CHEM_ID
CHEMBL177 ChEMBL_ID
CHEMBL1164318 ChEMBL_ID
CHEMBL4208954 ChEMBL_ID
D000583 MESH_DESCRIPTOR_UI
DB00479 DRUGBANK_ID
10894 IUPHAR_LIGAND_ID
3492 INN_ID
84319SGC3C UNII
37768 PUBCHEM_CID
2863 MMSL
35287 MMSL
4165 MMSL
d00087 MMSL
1269009 SNOMEDCT_US
387266001 SNOMEDCT_US
48836000 SNOMEDCT_US
4018137 VANDF
4019602 VANDF
002781 NDDF
004899 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6166 INJECTION 250 mg INTRAMUSCULAR ANDA 22 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6166 INJECTION 250 mg INTRAMUSCULAR ANDA 22 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6167 INJECTION 250 mg INTRAMUSCULAR ANDA 22 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6167 INJECTION 250 mg INTRAMUSCULAR ANDA 22 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0703-9032 INJECTION, SOLUTION 500 mg INTRAMUSCULAR ANDA 20 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0703-9040 INJECTION, SOLUTION 1 g INTRAMUSCULAR ANDA 20 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 23155-290 INJECTION, SOLUTION 250 mg INTRAMUSCULAR ANDA 20 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 23155-290 INJECTION, SOLUTION 250 mg INTRAMUSCULAR ANDA 20 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 23155-290 INJECTION, SOLUTION 250 mg INTRAMUSCULAR ANDA 20 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 23155-785 INJECTION, SOLUTION 500 mg INTRAMUSCULAR ANDA 20 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 23155-785 INJECTION, SOLUTION 500 mg INTRAMUSCULAR ANDA 20 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 23155-785 INJECTION, SOLUTION 500 mg INTRAMUSCULAR ANDA 20 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 23155-786 INJECTION, SOLUTION 1 g INTRAMUSCULAR ANDA 20 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 23155-786 INJECTION, SOLUTION 1 g INTRAMUSCULAR ANDA 20 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 23155-786 INJECTION, SOLUTION 1 g INTRAMUSCULAR ANDA 20 sections
amikacin sulfate HUMAN PRESCRIPTION DRUG LABEL 1 25021-173 INJECTION, SOLUTION 250 mg INTRAVENOUS ANDA 23 sections
amikacin sulfate HUMAN PRESCRIPTION DRUG LABEL 1 25021-173 INJECTION, SOLUTION 250 mg INTRAVENOUS ANDA 23 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 63323-815 INJECTION, SOLUTION 250 mg INTRAVENOUS ANDA 21 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 63323-815 INJECTION, SOLUTION 250 mg INTRAVENOUS ANDA 21 sections
Amikacin Sulfate Injection, 500 mg/2ml HUMAN PRESCRIPTION DRUG LABEL 1 70297-996 INJECTION 500 mg INTRAMUSCULAR Export only
Amikacin Sulfate Injection, 500 mg/2ml HUMAN PRESCRIPTION DRUG LABEL 1 71309-996 INJECTION 500 mg INTRAMUSCULAR Export only
ARIKAYCE HUMAN PRESCRIPTION DRUG LABEL 1 71558-590 SUSPENSION 590 mg RESPIRATORY (INHALATION) NDA 34 sections
ARIKAYCE HUMAN PRESCRIPTION DRUG LABEL 1 71558-590 SUSPENSION 590 mg RESPIRATORY (INHALATION) NDA 34 sections
ARIKAYCE HUMAN PRESCRIPTION DRUG LABEL 1 71558-590 SUSPENSION 590 mg RESPIRATORY (INHALATION) NDA 34 sections