Ofloxacin
Ocuflox, Ofloxacin (ofloxacin) is a small molecule pharmaceutical. Ofloxacin was first approved as Floxin on 1990-12-28. It is used to treat bacterial conjunctivitis, bacterial infections, bacterial skin diseases, bronchitis, and chlamydia infections amongst others in the USA.
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Commercial
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Ocuflox, Ofloxacin (discontinued: Floxin, Ofloxacin)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ocuflox | New Drug Application | 2024-06-13 |
| ofloxacin | ANDA | 2024-10-31 |
| ofloxacin ophth soln | ANDA | 2023-05-22 |
| ofloxacin ophthalmic | ANDA | 2022-10-28 |
| ofloxacin otic | ANDA | 2024-09-27 |
Indications
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Agency Specific
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ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01M: Quinolone antibacterials
— J01MA: Fluoroquinolone antibacterials, systemic
— J01MA01: Ofloxacin
— J01R: Combinations of antibacterials
— J01RA: Combinations of antibacterials
— J01RA09: Ofloxacin and ornidazole
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01A: Antiinfective ophthalmologics
— S01AE: Fluoroquinolone antiinfectives, ophthalmologic
— S01AE01: Ofloxacin
— S02: Otologicals
— S02A: Antiinfective drugs, otologic
— S02AA: Antiinfectives
— S02AA16: Ofloxacin
Clinical
Clinical Trials
414 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 | — | 5 | 8 | 30 | 50 | 30 | 120 |
| Communicable diseases | D003141 | — | — | 1 | 3 | 19 | 20 | 15 | 57 |
| Helicobacter infections | D016481 | EFO_1000961 | — | — | — | 4 | 23 | 13 | 40 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 4 | 10 | 17 | 5 | 8 | 38 |
| Pneumonia | D011014 | EFO_0003106 | — | — | 6 | 15 | 10 | 2 | 31 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | 3 | 3 | 10 | 7 | 3 | 24 |
| Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | — | 6 | 8 | 3 | 3 | 18 |
| Cataract | D002386 | HP_0000518 | H26.9 | 3 | 1 | 3 | 7 | 2 | 16 |
| Healthy volunteers/patients | — | — | — | 8 | 1 | — | 3 | 2 | 14 |
| Disease susceptibility | D004198 | — | — | — | — | 1 | 10 | 2 | 13 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute disease | D000208 | — | — | — | 2 | 5 | — | 2 | 8 |
| Otitis | D010031 | — | — | — | 2 | 6 | — | 1 | 7 |
| Prostatitis | D011472 | EFO_0003830 | N41 | — | 1 | 5 | — | 1 | 7 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | — | 1 | — | 3 | 6 |
| Rhinosinusitis | D000096825 | — | — | 1 | 2 | 3 | — | 1 | 6 |
| Bacterial infections | D001424 | — | A49 | 1 | — | 3 | — | 2 | 6 |
| Fibrosis | D005355 | — | — | 2 | 1 | 2 | — | — | 5 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 2 | 1 | 2 | — | — | 5 |
| Bacterial conjunctivitis | D003234 | EFO_1000829 | H10.0 | 1 | 3 | 2 | — | — | 5 |
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | — | 1 | — | 4 | 5 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myopia | D009216 | EFO_0003927 | H52.1 | 1 | 1 | — | — | 4 | 5 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | 2 | 2 | — | — | — | 3 |
| Pulmonary sarcoidosis | D017565 | DOID_13406 | D86.0 | 1 | 1 | — | — | — | 2 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | 1 | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 1 | — | — | — | 1 |
| Antibiotic prophylaxis | D019072 | — | — | — | 1 | — | — | — | 1 |
| Meningeal tuberculosis | D014390 | — | A17.0 | 1 | 1 | — | — | — | 1 |
| Pterygium | D011625 | — | H11.0 | 1 | 1 | — | — | — | 1 |
| Corneal diseases | D003316 | — | H18.9 | 1 | 1 | — | — | — | 1 |
| Hyperopia | D006956 | EFO_0006310 | H52.0 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | 1 | — | — | — | 1 | 2 |
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | 1 | — | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | — | — | — | — | 1 |
| Retinal diseases | D012164 | HP_0000479 | H35.9 | 1 | — | — | — | — | 1 |
| Hearing loss | D034381 | EFO_0004238 | H91.9 | 1 | — | — | — | — | 1 |
| Ototoxicity | D000081015 | — | — | 1 | — | — | — | — | 1 |
| Deafness | D003638 | EFO_0001063 | H91.9 | 1 | — | — | — | — | 1 |
| Escherichia coli infections | D004927 | EFO_1001318 | B96.20 | 1 | — | — | — | — | 1 |
| Sars-cov-2 | D000086402 | — | — | 1 | — | — | — | — | 1 |
| Short bowel syndrome | D012778 | — | K90.82 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | — | — | 5 | 5 |
| Retinal detachment | D012163 | EFO_0005773 | H33.2 | — | — | — | — | 3 | 3 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 3 | 3 |
| Endometritis | D004716 | EFO_1001312 | — | — | — | — | — | 3 | 3 |
| Ischemic stroke | D000083242 | — | — | — | — | — | — | 3 | 3 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 3 | 3 |
| Ischemia | D007511 | EFO_0000556 | — | — | — | — | — | 3 | 3 |
| Cerebral infarction | D002544 | — | I63 | — | — | — | — | 3 | 3 |
| Prosthesis-related infections | D016459 | EFO_1001406 | — | — | — | — | — | 2 | 2 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 2 | 2 |
Show 62 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ofloxacin |
| INN | ofloxacin |
| Description | Ofloxacin is a racemate comprising equimolar amounts of levofloxacin and dextrofloxacin. It is a synthetic fluoroquinolone antibacterial agent which inhibits the supercoiling activity of bacterial DNA gyrase, halting DNA replication. It has a role as a DNA synthesis inhibitor, an antiinfective agent, an antibacterial drug, an EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor and a topoisomerase IV inhibitor. It is a quinolone antibiotic, a fluoroquinolone antibiotic and a racemate. It contains a levofloxacin and a dextrofloxacin. |
| Classification | Small molecule |
| Drug class | antibacterials (quinolone derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC1COc2c(N3CCN(C)CC3)c(F)cc3c(=O)c(C(=O)O)cn1c23 |
Identifiers
| PDB | — |
| CAS-ID | 82419-36-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4 |
| ChEBI ID | 7731 |
| PubChem CID | 4583 |
| DrugBank | DB01165 |
| UNII ID | A4P49JAZ9H (ChemIDplus, GSRS) |
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Estimated US medical usage
Ofloxacin
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Safety
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95,975 adverse events reported
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