Gentamicin
Gentamicin, Pred (gentamicin) is a small molecule pharmaceutical. Gentamicin was first approved as Garamycin on 1982-01-01. It is used to treat bacterial eye infections, bacterial infections, bacterial skin diseases, central nervous system infections, and endocarditis amongst others in the USA. It is known to target transient receptor potential cation channel subfamily A member 1.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Gentamicin (discontinued: Apogen, Bristagen, Garamycin, Genoptic, Gentacidin, Gentak, Gentamicin, U-gencin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gentamicin sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GARAMYCIN | Merck & Co | N-050039 DISCN | 1982-01-01 | 1 products, RLD |
| GARAMYCIN | Merck & Co | N-050425 DISCN | 1982-01-01 | 1 products |
| GARAMYCIN | Merck & Co | N-050505 DISCN | 1982-01-01 | 1 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amolg a | unapproved drug other | 2019-03-15 |
| celestone-g | unapproved drug other | 2018-11-20 |
| gentak | ANDA | 2024-06-12 |
| gentamicin | ANDA | 2026-09-21 |
| gentamicin sulfate | ANDA | 2026-05-20 |
| gentamicin sulfate cream usp, 0.1% | ANDA | 2021-05-25 |
| gentamicin sulfate in sodium chloride | ANDA | 2023-01-26 |
| gentamicin sulfate opth solution | ANDA | 2026-03-17 |
| isotonic gentamicin sulfate | ANDA | 2009-06-25 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
D: Dermatologicals
— D06: Antibiotics and chemotherapeutics for dermatological use
— D06A: Antibiotics for topical use
— D06AX: Other antibiotics for topical use in atc
— D06AX07: Gentamicin
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01G: Aminoglycoside antibacterials
— J01GB: Other aminoglycosides in atc
— J01GB03: Gentamicin
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01A: Antiinfective ophthalmologics
— S01AA: Antibiotics, ophthalmologic
— S01AA11: Gentamicin
— S02: Otologicals
— S02A: Antiinfective drugs, otologic
— S02AA: Antiinfectives
— S02AA14: Gentamicin
— S03: Ophthalmological and otological preparations
— S03A: Antiinfectives, ophthalmologic and otologic
— S03AA: Antiinfectives
— S03AA06: Gentamicin
HCPCS
Code | Description |
|---|---|
| J1580 | Injection, garamycin, gentamicin, up to 80 mg |
Clinical
Clinical Trials
294 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 2 | 4 | 15 | 6 | 12 | 36 |
| Surgical wound infection | D013530 | — | — | 2 | 3 | 9 | 3 | 5 | 20 |
| Communicable diseases | D003141 | — | — | 1 | 1 | 9 | 3 | 6 | 19 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | 2 | 5 | 1 | 6 | 4 | 17 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | 4 | 5 | 3 | 6 | 16 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | 2 | 3 | 3 | 5 | 11 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | 1 | 2 | 6 | 10 |
| Appendicitis | D001064 | EFO_0007149 | K37 | — | 1 | 1 | 2 | 5 | 9 |
| Diabetic foot | D017719 | EFO_1001459 | — | 1 | 4 | 2 | 1 | 1 | 8 |
| Wound infection | D014946 | — | — | — | — | 3 | 3 | 2 | 8 |
Show 69 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cutaneous leishmaniasis | D016773 | — | B55.1 | — | 8 | 2 | — | 1 | 11 |
| Leishmaniasis | D007896 | EFO_0005044 | B55 | — | 7 | 2 | — | 1 | 10 |
| Toxemia | D014115 | — | — | — | 1 | 2 | — | 4 | 7 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | 1 | 2 | — | 1 | 4 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | 1 | 1 | — | 1 | 4 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 1 | 2 | 1 | — | 1 | 4 |
| Neurogenic urinary bladder | D001750 | HP_0000011 | N31 | 1 | 2 | 1 | — | 1 | 4 |
| Neutropenia | D009503 | — | D70 | — | 1 | 2 | — | — | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 2 | 2 | — | — | 2 |
| Severe acute malnutrition | D000067011 | — | — | — | 1 | 2 | — | — | 2 |
Show 49 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory tract infections | D012141 | — | J06.9 | 1 | 1 | — | — | 3 | 5 |
| Epidermolysis bullosa dystrophica | D016108 | — | Q81.2 | 3 | 3 | — | — | — | 3 |
| Cholangitis | D002761 | HP_0030151 | K83.0 | — | 1 | — | — | 2 | 3 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 1 | — | — | 1 | 2 |
| Nasopharyngeal carcinoma | D000077274 | — | — | — | 2 | — | — | — | 2 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | — | 2 | — | — | — | 2 |
| Enterocolitis | D004760 | EFO_1001481 | — | — | 1 | — | — | 1 | 2 |
| Junctional epidermolysis bullosa | D016109 | — | Q81.1 | 2 | 2 | — | — | — | 2 |
| Epidermolysis bullosa | D004820 | — | Q81 | 2 | 2 | — | — | — | 2 |
| Nasopharyngeal neoplasms | D009303 | — | — | — | 1 | — | — | — | 1 |
Show 23 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial drug resistance | D024881 | — | — | 1 | — | — | — | 1 | 2 |
| Duchenne muscular dystrophy | D020388 | EFO_0000429 | — | 2 | — | — | — | — | 2 |
| Infertility | D007246 | EFO_0000545 | — | 1 | — | — | — | — | 1 |
| Female infertility | D007247 | EFO_0008560 | N97 | 1 | — | — | — | — | 1 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | 1 | — | — | — | — | 1 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | 1 | — | — | — | — | 1 |
| Penetrating keratoplasty | D015948 | — | — | 1 | — | — | — | — | 1 |
| Mammaplasty | D016462 | — | — | 1 | — | — | — | — | 1 |
| Respiratory insufficiency | D012131 | — | J96.9 | 1 | — | — | — | — | 1 |
| Muscular dystrophies | D009136 | EFO_0000757 | G71.0 | 1 | — | — | — | — | 1 |
Show 8 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vestibular diseases | D015837 | EFO_0009691 | H81 | — | — | — | — | 6 | 6 |
| Tic disorders | D013981 | — | F95 | — | — | — | — | 4 | 4 |
| Ototoxicity | D000081015 | — | — | — | — | — | — | 4 | 4 |
| Sensation disorders | D012678 | — | H02.59 | — | — | — | — | 4 | 4 |
| Labyrinth diseases | D007759 | — | — | — | — | — | — | 4 | 4 |
| Bilateral vestibulopathy | D000071699 | — | — | — | — | — | — | 4 | 4 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | — | — | 3 | 3 |
| Dizziness | D004244 | — | R42 | — | — | — | — | 3 | 3 |
| Coinfection | D060085 | — | — | — | — | — | — | 2 | 2 |
| Neurilemmoma | D009442 | EFO_0000693 | — | — | — | — | — | 2 | 2 |
Show 56 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Gentamicin |
| INN | gentamicin |
| Description | Gentamicin is an antibiotic used to treat several types of bacterial infections. This may include bone infections, endocarditis, pelvic inflammatory disease, meningitis, pneumonia, urinary tract infections, and sepsis among others. It is not effective for gonorrhea or chlamydia infections. It can be given intravenously, by intramuscular injection, or topically. Topical formulations may be used in burns or for infections of the outside of the eye. It is often only used for two days until bacterial cultures determine what specific antibiotics the infection is sensitive to. The dose required should be monitored by blood testing.
|
| Classification | Small molecule |
| Drug class | antibiotics (Micromonospora strains) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CNC(C)[C@@H]1CC[C@@H](N)[C@@H](O[C@@H]2[C@@H](N)C[C@@H](N)[C@H](O[C@H]3OC[C@](C)(O)[C@H](NC)[C@H]3O)[C@H]2O)O1.CN[C@@H]1[C@@H](O)[C@@H](O[C@@H]2[C@@H](O)[C@H](O[C@H]3O[C@H](C(C)N)CC[C@H]3N)[C@@H](N)C[C@H]2N)OC[C@]1(C)O.CN[C@@H]1[C@@H](O)[C@@H](O[C@@H]2[C@@H](O)[C@H](O[C@H]3O[C@H](CN)CC[C@H]3N)[C@@H](N)C[C@H]2N)OC[C@]1(C)O |
Identifiers
| PDB | — |
| CAS-ID | 1403-66-3 |
| RxCUI | 1596450 |
| ChEMBL ID | CHEMBL3039597 |
| ChEBI ID | — |
| PubChem CID | 3467 |
| DrugBank | DB00798 |
| UNII ID | T6Z9V48IKG (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
TRPA1
TRPA1
Organism
Homo sapiens
Gene name
TRPA1
Gene synonyms
ANKTM1
NCBI Gene ID
Protein name
transient receptor potential cation channel subfamily A member 1
Protein synonyms
ankyrin-like with transmembrane domains 1, Ankyrin-like with transmembrane domains protein 1, p120, Transformation-sensitive protein p120, Wasabi receptor
Uniprot ID
Mouse ortholog
Trpa1 (277328)
transient receptor potential cation channel subfamily A member 1 (Q8BLA8)
Variants
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Estimated US medical usage
Gentamicin
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Gentamicin
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Prednisolone
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Gentamicin, Gentamicin sulfate, Gentamicin sulfate in sodium chloride, Isotonic gentamicin sulfate
Adverse Events
Top Adverse Reactions
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9,523 adverse events reported
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