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epinastine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antihistaminics | 1027 | 80012-43-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
direct H1-receptor antagonist and an inhibitor of the release of histamine from the mast cell, indicated for the prevention of itching associated with allergic conjunctivitis
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 1.15 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 40 % | |
| S (Water solubility) | 38 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAP3K7,MAPK10,MAPK7,NTRK2,PDK4,PDPK1,PIK3CB,PIK3CG,PIM2,PRKDC,STK33,TEK,TGFBR1 | 24 | |||
| kinase-selectivity-class | AXL | 1 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 20, 2019 | PMDA | Santen Pharmaceutical Co., Ltd. | |
| Oct. 16, 2003 | FDA | ALLERGAN |
FDA Adverse Event Reporting System (Female)
| 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 |
|---|---|---|---|---|---|---|
| Treatment failure | 131.68 | 23.96 | 80 | 1784 | 303848 | 90322735 |
| Platelet count decreased | 37.00 | 23.96 | 27 | 1837 | 136942 | 90489641 |
| Hepatic function abnormal | 35.94 | 23.96 | 18 | 1846 | 46270 | 90580313 |
| Alopecia areata | 34.16 | 23.96 | 8 | 1856 | 2007 | 90624576 |
| Drug eruption | 25.24 | 23.96 | 13 | 1851 | 35394 | 90591189 |
| Renal impairment | 24.48 | 23.96 | 19 | 1845 | 105402 | 90521181 |
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 |
|---|---|---|---|---|---|---|
| Treatment failure | 75.78 | 25.19 | 43 | 1954 | 62581 | 42556757 |
| Hepatic function abnormal | 72.23 | 25.19 | 39 | 1958 | 51528 | 42567810 |
| Interstitial lung disease | 34.73 | 25.19 | 29 | 1968 | 78433 | 42540905 |
| Decreased appetite | 33.36 | 25.19 | 43 | 1954 | 193094 | 42426244 |
| Pyrexia | 28.43 | 25.19 | 59 | 1938 | 393983 | 42225355 |
| Drug eruption | 28.25 | 25.19 | 16 | 1981 | 23059 | 42596279 |
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 | 98.85 | 23.05 | 52 | 3725 | 89243 | 110496279 |
| Interstitial lung disease | 47.95 | 23.05 | 39 | 3738 | 139295 | 110446227 |
| Pyrexia | 47.10 | 23.05 | 98 | 3679 | 898167 | 109687355 |
| Platelet count decreased | 46.87 | 23.05 | 48 | 3729 | 230395 | 110355127 |
| Drug eruption | 42.23 | 23.05 | 25 | 3752 | 53634 | 110531888 |
| Decreased appetite | 36.20 | 23.05 | 61 | 3716 | 475785 | 110109737 |
| Alopecia areata | 34.21 | 23.05 | 9 | 3768 | 2178 | 110583344 |
| Neutrophil count decreased | 29.79 | 23.05 | 28 | 3749 | 120913 | 110464609 |
| Pemphigoid | 29.19 | 23.05 | 14 | 3763 | 19693 | 110565829 |
| Pneumonia | 27.91 | 23.05 | 79 | 3698 | 876635 | 109708887 |
| Cardiac failure | 24.36 | 23.05 | 31 | 3746 | 187595 | 110397927 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | R06AX24 | RESPIRATORY SYSTEM ANTIHISTAMINES FOR SYSTEMIC USE ANTIHISTAMINES FOR SYSTEMIC USE Other antihistamines for systemic use |
| ATC | S01GX10 | SENSORY ORGANS OPHTHALMOLOGICALS DECONGESTANTS AND ANTIALLERGICS Other antiallergics |
| FDA MoA | N0000000122 | Adrenergic Agonists |
| FDA MoA | N0000000190 | Histamine H1 Receptor Antagonists |
| FDA EPC | N0000175519 | Histamine-1 Receptor Inhibitor |
| MeSH PA | D006633 | Histamine Antagonists |
| MeSH PA | D006634 | Histamine H1 Antagonists |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D018494 | Histamine Agents |
| FDA PE | N0000175628 | Decreased Histamine Release |
| FDA EPC | N0000175883 | Adrenergic Receptor Agonist |
| CHEBI has role | CHEBI:37955 | H<small><sub>1</sub></small>-receptor antagonist |
| CHEBI has role | CHEBI:37956 | histamine antagonist |
| CHEBI has role | CHEBI:50857 | anti-allergic agent |
| CHEBI has role | CHEBI:66981 | ophthalmology drug |
Related Drugs by ATC class:
R06AX Other antihistamines for systemic use 26 drugs
S01GX Other antiallergics 12 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Allergic conjunctivitis | indication | 473460002 | DOID:11204 |
| Ocular Itching | indication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 9.94 | 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 | ANTAGONIST | Ki | 8.90 | WOMBAT-PK | CHEMBL | |||
| Potassium voltage-gated channel subfamily H member 2 | Ion channel | IC50 | 4 | WOMBAT-PK | |||||
| Multidrug resistance protein 1 | Transporter | WOMBAT-PK | |||||||
| 5-hydroxytryptamine receptor 2A | GPCR | WOMBAT-PK | |||||||
| Alpha-1A adrenergic receptor | GPCR | WOMBAT-PK | |||||||
| Histamine H2 receptor | GPCR | WOMBAT-PK | |||||||
| Solute carrier family 22 member 2 | Transporter | IC50 | 5.37 | CHEMBL | |||||
| Multidrug and toxin extrusion protein 1 | Transporter | IC50 | 5.96 | CHEMBL | |||||
| Alpha-2A adrenergic receptor | GPCR | WOMBAT-PK | |||||||
| Multidrug and toxin extrusion protein 2 | Transporter | IC50 | 4.53 | CHEMBL | |||||
| Histamine H1 receptor | GPCR | IC50 | 8.80 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4021466 | VUID |
| N0000148850 | NUI |
| D01713 | KEGG_DRUG |
| 108929-04-0 | SECONDARY_CAS_RN |
| 4021466 | VANDF |
| C0078442 | UMLSCUI |
| CHEBI:51032 | CHEBI |
| CHEMBL1106 | ChEMBL_ID |
| CHEMBL1200491 | ChEMBL_ID |
| DB00751 | DRUGBANK_ID |
| C053090 | MESH_SUPPLEMENTAL_RECORD_UI |
| 3241 | PUBCHEM_CID |
| 7176 | IUPHAR_LIGAND_ID |
| 5953 | INN_ID |
| Q13WX941EF | UNII |
| 236961 | RXNORM |
| 17645 | MMSL |
| 181234 | MMSL |
| 007311 | NDDF |
| 007312 | NDDF |
| 407068009 | SNOMEDCT_US |
| 407069001 | SNOMEDCT_US |
| 427671005 | SNOMEDCT_US |
| Q13WX941EF | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| EPINASTINE HYDROCHLORIDE | Human Prescription Drug Label | 1 | 62756-329 | SOLUTION | 0.50 mg | OPHTHALMIC | ANDA | 22 sections |
| EPINASTINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70069-008 | SOLUTION/ DROPS | 0.50 mg | OPHTHALMIC | ANDA | 20 sections |