Benoxinate
Altafluor Benox, Benoxinate / Fluorescein (benoxinate) is a small molecule pharmaceutical. Benoxinate was first approved as Benoxinate hydrochloride on 1982-01-01.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Combinations
Altafluor benox, Fluorescein benoxinate
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Benoxinate hydrochloride
+
Fluorescein sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ALTAFLUOR BENOX | Altaire Pharmaceuticals | N-208582 RX | 2017-12-14 | 1 products, RLD, RS |
| FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE | Bausch Health Companies | N-211039 RX | 2020-03-09 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| altafluor | New Drug Application | 2017-12-30 |
| fluorescein sodium and benoxinate hydrochloride | NDA authorized generic | 2023-03-16 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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ATC Codes
D: Dermatologicals
— D04: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04A: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04AB: Anesthetics for topical use
— D04AB03: Oxybuprocaine
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01H: Local anesthetics, ophthalmologic
— S01HA: Local anesthetics
— S01HA02: Oxybuprocaine
HCPCS
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Clinical
Clinical Trials
19 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myopia | D009216 | EFO_0003927 | H52.1 | — | — | — | 1 | 1 | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Retinopathy of prematurity | D012178 | EFO_1001158 | H35.1 | — | — | 1 | — | 1 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | — | 1 |
| Communicable diseases | D003141 | — | — | — | — | 1 | — | — | 1 |
| Keratitis | D007634 | HP_0000491 | H16 | — | — | 1 | — | — | 1 |
| Local anesthesia | D000772 | — | — | — | — | 1 | — | — | 1 |
| Retinal diseases | D012164 | HP_0000479 | H35.9 | — | — | 1 | — | — | 1 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cataract | D002386 | HP_0000518 | H26.9 | — | 2 | — | — | 1 | 3 |
| Conscious sedation | D016292 | — | — | — | 2 | — | — | — | 2 |
| Adenoidectomy | D000233 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | 1 | — | — | — | — | 1 |
| Hypotension | D007022 | EFO_0005251 | I95 | 1 | — | — | — | — | 1 |
| Orthostatic hypotension | D007024 | — | I95.1 | 1 | — | — | — | — | 1 |
| Nervous system diseases | D009422 | — | G00-G99 | 1 | — | — | — | — | 1 |
| Primary dysautonomias | D054969 | — | — | 1 | — | — | — | — | 1 |
| Orthostatic intolerance | D054971 | — | — | 1 | — | — | — | — | 1 |
| Acute pain | D059787 | — | R52 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Refractive errors | D012030 | EFO_0003908 | H52.7 | — | — | — | — | 2 | 2 |
| Lacrimal apparatus diseases | D007766 | HP_0009926 | H04 | — | — | — | — | 2 | 2 |
| Dry eye syndromes | D015352 | — | H04.12 | — | — | — | — | 2 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Intravitreal injections | D058449 | — | — | — | — | — | — | 1 | 1 |
| Blepharitis | D001762 | EFO_0009536 | H01.0 | — | — | — | — | 1 | 1 |
| Corneal diseases | D003316 | — | H18.9 | — | — | — | — | 1 | 1 |
| Microbiota | D064307 | — | — | — | — | — | — | 1 | 1 |
| Neuralgia | D009437 | EFO_0009430 | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Benoxinate |
| INN | oxybuprocaine |
| Description | Oxybuprocaine is a benzoate ester in which 4-amino-3-butoxybenzoic acid and 2-(diethylamino)ethanol have combined to form the ester bond; an ester-based local anaesthetic (ester "caine") used especially in ophthalmology and otolaryngology. It has a role as a local anaesthetic, a topical anaesthetic and a drug allergen. It is a benzoate ester, a tertiary amino compound, a substituted aniline and an amino acid ester. It is functionally related to a 2-diethylaminoethanol. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCOc1cc(C(=O)OCCN(CC)CC)ccc1N |
Identifiers
| PDB | — |
| CAS-ID | 99-43-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200 |
| ChEBI ID | 309594 |
| PubChem CID | 4633 |
| DrugBank | DB00892 |
| UNII ID | AXQ0JYM303 (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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162 adverse events reported
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