bepotastine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antihistaminics 341 125602-71-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • bepotastine
  • bepotastine besilate
  • bepreve
  • bepotastine besylate
  • Molecular weight: 388.89
  • Formula: C21H25ClN2O3
  • CLOGP: 0.28
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 62.66
  • ALOGS: -3.89
  • ROTB: 8

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 8, 2009 FDA BAUSCH AND LOMB INC

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hepatic function abnormal 44.10 29.76 21 736 39238 29534532

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hepatic function abnormal 62.06 25.06 30 1453 64283 64432966
Interstitial lung disease 42.58 25.06 27 1456 97705 64399544
Platelet count decreased 33.58 25.06 29 1454 167682 64329567
Erythema multiforme 30.45 25.06 12 1471 15689 64481560
Drug eruption 29.30 25.06 15 1468 36121 64461128
Neutrophil count decreased 27.92 25.06 19 1464 77177 64420072

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
FDA EPC N0000175587 Histamine-1 Receptor Antagonist
MeSH PA D018926 Anti-Allergic Agents
CHEBI has role CHEBI:37955 H1 receptor antagonists
CHEBI has role CHEBI:50857 anti-allergic drugs

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Allergic conjunctivitis indication 473460002 DOID:11204




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.54 acidic
pKa2 9.51 Basic
pKa3 4.25 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Histamine H1 receptor GPCR ANTAGONIST DRUGBANK CHEMBL

External reference:

IDSource
4029223 VUID
N0000181653 NUI
D01654 KEGG_DRUG
190786-44-8 SECONDARY_CAS_RN
658552 RXNORM
C2698371 UMLSCUI
CHEBI:71204 CHEBI
CHEMBL1201758 ChEMBL_ID
DB04890 DRUGBANK_ID
CHEMBL1201759 ChEMBL_ID
C108476 MESH_SUPPLEMENTAL_RECORD_UI
C511534 MESH_SUPPLEMENTAL_RECORD_UI
164522 PUBCHEM_CID
7466 IUPHAR_LIGAND_ID
7648 INN_ID
HYD2U48IAS UNII
167734 MMSL
26713 MMSL
347164 MMSL
010865 NDDF
010866 NDDF
4029223 VANDF
4029224 VANDF
443616002 SNOMEDCT_US
707083009 SNOMEDCT_US
770926005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Bepotastine Besilate HUMAN PRESCRIPTION DRUG LABEL 1 0378-7055 SOLUTION/ DROPS 15 mg OPHTHALMIC ANDA 24 sections
Bepreve HUMAN PRESCRIPTION DRUG LABEL 1 24208-629 SOLUTION/ DROPS 15 mg OPHTHALMIC NDA 21 sections
Bepotastine Besilate HUMAN PRESCRIPTION DRUG LABEL 1 24208-630 SOLUTION/ DROPS 15 mg OPHTHALMIC NDA authorized generic 22 sections
BEPREVE HUMAN PRESCRIPTION DRUG LABEL 1 54868-6299 SOLUTION/ DROPS 15 mg OPHTHALMIC NDA 21 sections
Bepotastine Besilate HUMAN PRESCRIPTION DRUG LABEL 1 60505-6111 SOLUTION/ DROPS 15 mg OPHTHALMIC ANDA 22 sections