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

Stem definition	Drug id	CAS RN
antihistaminics	341	125602-71-3

Description:

Molecule

Description

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:

Date	Agency	Company	Orphan
Sept. 8, 2009	FDA	BAUSCH AND LOMB INC

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hepatic function abnormal	44.16	27.89	22	891	44341	34911677
Nasal turbinate abnormality	30.16	27.89	4	909	26	34955992

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hepatic function abnormal	64.77	23.35	32	1769	73075	79669512
Interstitial lung disease	39.50	23.35	27	1774	112573	79630014
Platelet count decreased	36.13	23.35	32	1769	194632	79547955
Erythema multiforme	32.74	23.35	13	1788	17638	79724949
Neutrophil count decreased	31.68	23.35	22	1779	93937	79648650
Nasal turbinate abnormality	29.39	23.35	4	1797	38	79742549
Pemphigoid	27.43	23.35	11	1790	15304	79727283
Drug eruption	26.78	23.35	15	1786	43920	79698667
Hypopituitarism	24.68	23.35	7	1794	3392	79739195

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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 | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Allergic conjunctivitis	indication	473460002	DOID:11204

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Histamine H1 receptor	GPCR	P35367	HRH1_HUMAN	ANTAGONIST				DRUGBANK	CHEMBL

External reference:

ID	Source
4029223	VUID
N0000181653	NUI
D01654	KEGG_DRUG
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
190786-44-8	SECONDARY_CAS_RN
HYD2U48IAS	UNII
167734	MMSL
26713	MMSL
347164	MMSL
443616002	SNOMEDCT_US
707083009	SNOMEDCT_US
770926005	SNOMEDCT_US
4029223	VANDF
4029224	VANDF
010865	NDDF
010866	NDDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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
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
Bepotastine Besilate Ophthalmic Solution 1.5%	Human Prescription Drug Label	1	46708-598	SOLUTION/ DROPS	15 mg	OPHTHALMIC	ANDA	21 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
Bepotastine Besilate	HUMAN PRESCRIPTION DRUG LABEL	1	60505-6111	SOLUTION/ DROPS	15 mg	OPHTHALMIC	ANDA	22 sections
Bepotastine Besilate Ophthalmic Solution 1.5%	Human Prescription Drug Label	1	62332-598	SOLUTION/ DROPS	15 mg	OPHTHALMIC	ANDA	21 sections
Bepotastine Besilate	HUMAN PRESCRIPTION DRUG LABEL	1	82260-630	SOLUTION/ DROPS	15 mg	OPHTHALMIC	NDA authorized generic	21 sections