Tobrex, Tobi podhaler(tobramycin)
Bethkis, Kitabis, Nebcin, Tobi, Tobradex, Tobrasone, Tobrex, Vantobra, Zylet (tobramycin) is a small molecule pharmaceutical. Tobramycin was first approved as Tobrex on 1982-01-01. It is used to treat bacterial eye infections, bacterial infections, central nervous system infections, infectious bone diseases, and infectious skin diseases amongst others in the USA. It has been approved in Europe to treat cystic fibrosis and respiratory tract infections.
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Novartis Pharmaceuticals
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| musculoskeletal diseases | D009140 |
| digestive system diseases | D004066 |
| respiratory tract diseases | D012140 |
| nervous system diseases | D009422 |
| eye diseases | D005128 |
| urogenital diseases | D000091642 |
| hereditary congenital and neonatal diseases and abnormalities | D009358 |
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Bethkis, Kitabis, Tobi, Tobrex (generic drugs available since 1984-12-13, discontinued: Aktob, Nebcin)
CombinationsTobradex, Zylet (generic drugs available since 1984-12-13, discontinued: Tobrasone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dexamethasone
+
Tobramycin
Fluorometholone acetate
+
Tobramycin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TOBRASONE | Eyevance | N-050628 DISCN | 1989-07-21 | 1 products |
Hide discontinued
Loteprednol etabonate
+
Tobramycin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZYLET | Bausch Health Companies | N-050804 RX | 2004-12-14 | 1 products, RLD, RS |
Tobramycin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BETHKIS | Chiesi Farmaceutici | N-201820 RX | 2012-10-12 | 1 products, RLD, RS |
| TOBI | Mylan | N-050753 RX | 1997-12-22 | 1 products, RLD, RS |
| TOBI PODHALER | Mylan | N-201688 RX | 2013-03-22 | 1 products, RLD, RS |
| TOBREX | Novartis | N-050541 RX | 1982-01-01 | 1 products, RLD, RS |
| TOBREX | Novartis | N-050555 RX | 1982-01-01 | 1 products, RLD, RS |
| KITABIS PAK | PulmoFlow | N-205433 RX | 2014-12-02 | 1 products |
Tobramycin sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TOBRAMYCIN SULFATE | Fresenius Kabi | N-050789 RX | 2004-07-13 | 1 products |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bethkis | New Drug Application | 2020-11-04 |
| kitabis pak | New Drug Application | 2021-07-22 |
| tobi | New Drug Application | 2023-02-15 |
| tobradex | New Drug Application | 2023-04-19 |
| tobramycin | ANDA | 2023-03-15 |
| tobrex | New Drug Application | 2023-04-19 |
| zylet | New Drug Application | 2021-10-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bacterial eye infections | — | D015818 | — |
| bacterial infections | — | D001424 | A49 |
| central nervous system infections | EFO_1001456 | D002494 | A81 |
| infectious bone diseases | — | D001850 | — |
| infectious skin diseases | — | D012874 | — |
| intraabdominal infections | — | D059413 | — |
| pseudomonas infections | EFO_0001076 | D011552 | — |
| respiratory tract infections | — | D012141 | J06.9 |
| staphylococcal infections | — | D013203 | A49.01 |
| urinary tract infections | EFO_0003103 | D014552 | N39.0 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Tobramycin, Tobi Podhaler, Mylan Speciality Lp | |||
| 10207066 | 2030-11-04 | DP | U-909 |
| 8869794 | 2028-09-12 | DP | U-909 |
| 7559325 | 2025-10-27 | DP | |
| 8664187 | 2025-06-20 | U-909 | |
| 11484671 | 2024-11-07 | DP | U-909 |
| 8069851 | 2024-09-24 | DP | |
| RE47526 | 2024-04-09 | DP | |
| 7516741 | 2024-01-11 | DP | |
| Dexamethasone / Tobramycin, Tobradex St, Eyevance | |||
| 7795316 | 2028-08-03 | DP | U-1082 |
| 8101582 | 2027-12-19 | DP | U-1082 |
| 8450287 | 2027-12-19 | DP | |
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01G: Aminoglycoside antibacterials
— J01GB: Other aminoglycosides in atc
— J01GB01: Tobramycin
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01A: Antiinfective ophthalmologics
— S01AA: Antibiotics, ophthalmologic
— S01AA12: Tobramycin
HCPCS
Code | Description |
|---|---|
| J3260 | Injection, tobramycin sulfate, up to 80 mg |
| J7682 | Tobramycin, inhalation solution, fda-approved final product, non-compounded, unit dose form, administered through dme, per 300 milligrams |
| J7685 | Tobramycin, inhalation solution, compounded product, administered through dme, unit dose form, per 300 milligrams |
Clinical
Clinical Trials
114 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 8 | 5 | 16 | 10 | 7 | 44 |
| Cataract | D002386 | EFO_0001059 | H26.9 | — | — | 3 | 1 | 3 | 7 |
| Bronchiectasis | D001987 | HP_0002110 | J47 | 1 | 1 | 1 | 1 | 1 | 4 |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | — | — | 3 | — | 3 |
| Open fractures | D005597 | — | — | 2 | 1 | — | 3 | ||
| Chalazion | D017043 | EFO_0007363 | H00.1 | — | — | — | 1 | 1 | 2 |
| Conjunctivitis | D003231 | H10 | — | — | 1 | 1 | — | 2 | |
| Inflammation | D007249 | — | — | 1 | 1 | — | 2 | ||
| Replacement arthroplasty knee | D019645 | — | — | 1 | 1 | — | 2 | ||
| Surgical wound infection | D013530 | — | — | 1 | 1 | — | 2 |
Show 10 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Blepharitis | D001762 | EFO_0009536 | H01.0 | — | — | 2 | — | 1 | 3 |
| Bacterial conjunctivitis | D003234 | EFO_1000829 | H10.0 | — | — | 3 | — | — | 3 |
| Pseudomonas aeruginosa | D011550 | NCBITaxon_287 | — | 1 | 2 | — | — | 3 | |
| Pseudomonas infections | D011552 | EFO_0001076 | — | — | 3 | — | — | 3 | |
| Keratitis | D007634 | H16 | — | — | 2 | — | — | 2 | |
| Infections | D007239 | EFO_0000544 | 1 | 1 | 1 | — | — | 2 | |
| Pulmonary infarction | D054060 | EFO_1001408 | — | — | 1 | — | — | 1 | |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | 1 | — | — | 1 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | 1 | — | — | 1 |
| Postoperative complications | D011183 | — | — | 1 | — | — | 1 |
Show 6 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Burns | D002056 | T30.0 | 1 | 1 | — | — | — | 1 | |
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | 1 | — | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dry eye syndromes | D015352 | H04.12 | 1 | — | — | — | 1 | 2 | |
| Bronchopulmonary dysplasia | D001997 | P27.8 | 1 | — | — | — | — | 1 | |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | 1 | — | — | — | — | 1 |
| Burkholderia infections | D019121 | EFO_1001280 | 1 | — | — | — | — | 1 | |
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
| Diabetic foot | D017719 | EFO_1001459 | 1 | — | — | — | — | 1 | |
| Allergic conjunctivitis | D003233 | EFO_0007141 | H10.44 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | — | — | 2 | 2 |
| Chronic bronchitis | D029481 | J42 | — | — | — | — | 1 | 1 | |
| Corneal transplantation | D016039 | EFO_0010676 | — | — | — | — | 1 | 1 | |
| Refractive errors | D012030 | EFO_0003908 | H52.7 | — | — | — | — | 1 | 1 |
| Myopia | D009216 | H52.1 | — | — | — | — | 1 | 1 | |
| Ocular hypertension | D009798 | EFO_1001069 | H40.0 | — | — | — | — | 1 | 1 |
| Corneal ulcer | D003320 | H16.0 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | TOBRAMYCIN |
| INN | tobramycin |
| Description | Tobramycin is a amino cyclitol glycoside that is kanamycin B lacking the 3-hydroxy substituent from the 2,6-diaminoglucose ring. It has a role as an antibacterial agent, an antimicrobial agent and a toxin. It is functionally related to a kanamycin B. It is a conjugate base of a tobramycin(5+). |
| Classification | Small molecule |
| Drug class | antibiotics (Streptomyces strain) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | NC[C@H]1O[C@H](O[C@@H]2[C@@H](N)C[C@@H](N)[C@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H]2O)[C@H](N)C[C@@H]1O |
Identifiers
| PDB | — |
| CAS-ID | 32986-56-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1747 |
| ChEBI ID | 28864 |
| PubChem CID | 36294 |
| DrugBank | DB00684 |
| UNII ID | VZ8RRZ51VK (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Tobramycin
Adverse Events
Top Adverse Reactions
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2,063 adverse events reported
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