Ofloxacin
Ocuflox (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
Trade Name
FDA
EMA
Ocuflox (generic drugs available since 2003-09-02, discontinued: Floxin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ofloxacin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OCUFLOX | Allergan | N-019921 RX | 1993-07-30 | 1 products, RLD, RS |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bacterial conjunctivitis | EFO_1000829 | D003234 | H10.0 |
| bacterial infections | — | D001424 | A49 |
| bacterial skin diseases | — | D017192 | — |
| bronchitis | — | D001991 | J40 |
| chlamydia infections | EFO_0007205 | D002690 | A74.9 |
| corneal ulcer | — | D003320 | H16.0 |
| cystitis | EFO_1000025 | D003556 | N30 |
| epididymitis | HP_0000031 | D004823 | N45.1 |
| escherichia coli infections | EFO_1001318 | D004927 | B96.20 |
| gonorrhea | DOID_7551 | D006069 | A54 |
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Agency Specific
FDA
EMA
No data
Patent Expiration
No data
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
209 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acromegaly | D000172 | 3 | 7 | 13 | 14 | 6 | 43 | ||
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 4 | 12 | 8 | 2 | — | 24 |
| Neoplasms | D009369 | C80 | 2 | 5 | 3 | 2 | — | 11 | |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 1 | 3 | 1 | 4 | 2 | 9 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | 1 | 3 | 1 | 3 | 8 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 1 | — | 3 | 2 | 8 |
| Hepatorenal syndrome | D006530 | K76.7 | — | 4 | 2 | 1 | 1 | 6 | |
| Esophageal and gastric varices | D004932 | EFO_0009545 | I85 | 1 | 1 | — | 3 | 1 | 5 |
| Ascites | D001201 | HP_0001541 | R18 | — | 2 | 1 | 1 | — | 3 |
| Pancreatic fistula | D010185 | — | — | — | 1 | 1 | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 5 | 1 | — | 1 | 8 |
| Carcinoid tumor | D002276 | D3A.00 | 1 | — | 4 | — | — | 5 | |
| Colorectal neoplasms | D015179 | — | 1 | 4 | — | — | 5 | ||
| Prostatic neoplasms | D011471 | C61 | — | 3 | 1 | — | — | 4 | |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 2 | 3 | — | — | 4 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | — | 4 | — | — | 4 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 2 | — | 2 | 4 |
| Autosomal dominant polycystic kidney | D016891 | EFO_1001496 | Q61.2 | — | 2 | 2 | — | — | 3 |
| Prader-willi syndrome | D011218 | Orphanet_739 | Q87.11 | — | — | 1 | — | 2 | 3 |
| Sarcoma | D012509 | 1 | — | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroendocrine carcinoma | D018278 | — | 6 | — | — | — | 6 | ||
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | 2 | — | — | 2 | 4 |
| Esophageal neoplasms | D004938 | C15 | — | 1 | — | — | 3 | 4 | |
| Neuroblastoma | D009447 | EFO_0000621 | 1 | 2 | — | — | — | 3 | |
| Meningioma | D008579 | EFO_0003098 | D32.9 | — | 3 | — | — | — | 3 |
| Islet cell adenoma | D007516 | EFO_0007331 | D13.7 | 1 | 2 | — | — | — | 3 |
| Islet cell carcinoma | D018273 | C25.4 | — | 3 | — | — | — | 3 | |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | 1 | — | — | 1 | 2 |
| Medulloblastoma | D008527 | — | 2 | — | — | — | 2 | ||
| Pheochromocytoma | D010673 | 1 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 5 | — | — | — | — | 5 | ||
| Insulin resistance | D007333 | EFO_0002614 | 2 | — | — | — | 1 | 3 | |
| Pure autonomic failure | D054970 | 1 | — | — | — | — | 1 | ||
| Orthostatic hypotension | D007024 | I95.1 | 1 | — | — | — | — | 1 | |
| Central nervous system neoplasms | D016543 | 1 | — | — | — | — | 1 | ||
| Merkel cell carcinoma | D015266 | EFO_1001471 | C4A | 1 | — | — | — | — | 1 |
| Paraganglioma | D010235 | 1 | — | — | — | — | 1 | ||
| Medullary carcinoma | D018276 | 1 | — | — | — | — | 1 | ||
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | — | — | — | 1 |
| Intraabdominal infections | D059413 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | — | 2 | 2 |
| Weight loss | D015431 | HP_0001824 | — | — | — | — | 2 | 2 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | — | 2 | 2 |
| Duodenal neoplasms | D004379 | — | — | — | — | 1 | 1 | ||
| Immunosuppression therapy | D007165 | — | — | — | — | 1 | 1 | ||
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | — | 1 | 1 |
| Nutrition disorders | D009748 | EFO_0001069 | — | — | — | — | 1 | 1 | |
| Dumping syndrome | D004377 | EFO_1001307 | K91.1 | — | — | — | — | 1 | 1 |
| Feeding and eating disorders | D001068 | F50 | — | — | — | — | 1 | 1 | |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | — | — | — | 1 | 1 |
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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) |
Target
Agency Approved
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Alternate
No data
Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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30,361 adverse events reported
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