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Butoconazole
Femstat (butoconazole) is a small molecule pharmaceutical. Butoconazole was first approved as Femstat on 1985-11-25. It is used to treat mycoses and vulvovaginal candidiasis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Butoconazole nitrate
Tradename
Company
Number
Date
Products
FEMSTAT 3BayerN-020421 DISCN1995-12-21
1 products, RLD
BUTOCONAZOLE NITRATEPadagisN-019881 DISCN1997-02-07
1 products
FEMSTATRocheN-019215 DISCN1985-11-25
1 products
FEMSTATRocheN-019359 DISCN1985-11-25
1 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
gynazole 1ANDA2021-02-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mycoses—D009181B35-B49
vulvovaginal candidiasisEFO_0007543D002181B37.3
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
G: Genito urinary system and sex hormones
— G01: Gynecological antiinfectives and antiseptics
— G01A: Antiinfectives and antiseptics, excl. combinations with corticosteroids
— G01AF: Imidazole derivatives, gyncological antiinfectives
— G01AF15: Butoconazole
HCPCS
No data
Clinical
Clinical Trials
8 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypersensitivityD006967EFO_0003785T78.40——2——2
Photoallergic dermatitisD017454L56.2——1——1
Phototoxic dermatitisD017484——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Tinea pedisD014008EFO_0007512B35.321———3
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBUTOCONAZOLE
INNbutoconazole
Description
Butoconazole is a member of the class of imidazoles that is 1H-imidazole in which the hydrogen attached to the nitrogen is substituted by a 4-(4-chlorophenyl)-2-[(2,6-dichlorophenyl)sulfanyl]butyl group. An antifungal agent, it is used as its nitrate salt in gynaecology for treatment of vulvovaginal infections caused by Candida species, particularly Candida albicans. It is a member of imidazoles, an aryl sulfide, a dichlorobenzene, a member of monochlorobenzenes, an imidazole antifungal drug and a conazole antifungal drug. It is a conjugate base of a butoconazole(1+).
Classification
Small molecule
Drug classsystemic antifungals (miconazole type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Clc1ccc(CCC(Cn2ccnc2)Sc2c(Cl)cccc2Cl)cc1
Identifiers
PDB—
CAS-ID64872-76-0
RxCUI19884
ChEMBL IDCHEMBL1295
ChEBI ID3240
PubChem CID47472
DrugBankDB00639
UNII ID0Q771797PH (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 185 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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792 adverse events reported
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