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

Stem definition	Drug id	CAS RN
prednisone and prednisolone derivatives	1611	82034-46-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: loteprednol etabonate lenoxin lotemax	An androstadiene derivative corticosteroid that is used as an ANTI-ALLERGIC AGENT for the treatment of inflammatory and allergic eye conditions. Molecular weight: 466.96 Formula: C24H31ClO7 CLOGP: 3.34 LIPINSKI: 0 HAC: 7 HDO: 1 TPSA: 99.13 ALOGS: -4.83 ROTB: 7 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

loteprednol etabonate
lenoxin
lotemax

An androstadiene derivative corticosteroid that is used as an ANTI-ALLERGIC AGENT for the treatment of inflammatory and allergic eye conditions.

Molecular weight: 466.96
Formula: C24H31ClO7
CLOGP: 3.34
LIPINSKI: 0
HAC: 7
HDO: 1
TPSA: 99.13
ALOGS: -4.83
ROTB: 7

Status: OFP

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

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BA (Bioavailability)	0 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
March 9, 1998	FDA	BAUSCH AND LOMB

FDA Adverse Event Reporting System (Female)

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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
Eye irritation	244.75	20.46	76	3237	21895	63463814
Eye pain	132.86	20.46	54	3259	33800	63451909
Ocular hyperaemia	115.68	20.46	45	3268	25099	63460610
Intraocular pressure increased	111.51	20.46	31	3282	6047	63479662
Vision blurred	77.07	20.46	52	3261	91872	63393837
Corneal oedema	69.31	20.46	16	3297	1477	63484232
Foreign body sensation in eyes	62.90	20.46	16	3297	2218	63483491
Lacrimation increased	57.96	20.46	26	3287	20605	63465104
Cataract	56.87	20.46	36	3277	57017	63428692
Eye pruritus	50.76	20.46	23	3290	18648	63467061

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FDA Adverse Event Reporting System (Male)

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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
Eye irritation	93.80	29.53	25	994	7536	34948376
Eye pain	83.75	29.53	26	993	13436	34942476
Intraocular pressure increased	62.95	29.53	17	1002	5366	34950546
Corneal oedema	51.05	29.53	11	1008	1340	34954572
Vision blurred	41.12	29.53	22	997	45941	34909971
Ulcerative keratitis	37.76	29.53	9	1010	1720	34954192
Diffuse lamellar keratitis	35.01	29.53	4	1015	4	34955908
Corneal striae	33.39	29.53	4	1015	8	34955904
Corneal disorder	31.90	29.53	7	1012	927	34954985
Corneal dystrophy	31.73	29.53	5	1014	106	34955806

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FDA Adverse Event Reporting System (Geriatric)

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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
Eye irritation	216.01	20.89	65	3335	20616	79720372
Eye pain	155.85	20.89	59	3341	37519	79703469
Intraocular pressure increased	109.37	20.89	32	3368	9173	79731815
Corneal oedema	99.72	20.89	23	3377	2597	79738391
Vision blurred	84.88	20.89	54	3346	105844	79635144
Ocular hyperaemia	80.99	20.89	34	3366	28172	79712816
Diffuse lamellar keratitis	66.97	20.89	8	3392	8	79740980
Dacryostenosis acquired	62.86	20.89	12	3388	540	79740448
Ulcerative keratitis	58.15	20.89	16	3384	3673	79737315
Corneal striae	55.12	20.89	7	3393	16	79740972

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	S01BA14	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Corticosteroids, plain
CHEBI has role	CHEBI:35679	antilipemic drugs
FDA EPC	N0000175576	Corticosteroid
FDA MoA	N0000175450	Corticosteroid Hormone Receptor Agonists
MeSH PA	D018926	Anti-Allergic Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Herpes zoster keratoconjunctivitis	indication	42448002
Punctate keratitis	indication	42513006	DOID:12197
Iritis	indication	65074000	DOID:1406
Perforation of cornea	indication	74895004
Iridocyclitis	indication	77971008
Corneal abrasion	indication	85848002
Uveitis	indication	128473001	DOID:13141
Ocular rosacea	indication	200933006
Herpes zoster keratitis	indication	397573005
Rosacea	indication	398909004	DOID:8881

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.33	acidic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	10058511	May 3, 2033	A METHOD FOR DELIVERING A PHARMACEUTICAL AGENT ACROSS A MUCOSAL BARRIER
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	10857096	May 3, 2033	A METHOD FOR TREATING DRY EYE IN A PATIENT
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	10940108	May 3, 2033	A METHOD FOR TREATING DRY EYE IN A PATIENT
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	10945948	May 3, 2033	A METHOD FOR TREATING DRY EYE IN A PATIENT
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	10993908	May 3, 2033	ADMINISTRATION TO THE EYE OF A PATIENT FOR TREATMENT OF DRY EYE CONDITION
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	11219596	May 3, 2033	A METHOD FOR TREATING DRY EYE IN A PATIENT
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	11596599	May 3, 2033	A METHOD FOR TREATING DRY EYE IN A PATIENT
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	9056057	May 3, 2033	A METHOD FOR DELIVERING A COMPOSITION TO A MUCUS MEMBRANE
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	9532955	May 3, 2033	A METHOD FOR DELIVERING A COMPOSITION TO A MUCUS MEMBRANE
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	9737491	May 3, 2033	A METHOD FOR DELIVERING A PHARMACEUTICAL AGENT ACROSS A MUCOSAL BARRIER

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	Oct. 26, 2023	NEW PRODUCT

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST				DRUGBANK	CHEMBL

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External reference:

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ID	Source
007442	NDDF
007443	NDDF
108857005	SNOMEDCT_US
11633	MMSL
129260-79-3	SECONDARY_CAS_RN
1692	MMSL
202988	RXNORM
315769	MMSL
387047007	SNOMEDCT_US
4021086	VUID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ALREX	HUMAN PRESCRIPTION DRUG LABEL	1	16590-007	SUSPENSION/ DROPS	2 mg	OPHTHALMIC	NDA	20 sections
ALREX	HUMAN PRESCRIPTION DRUG LABEL	1	24208-353	SUSPENSION/ DROPS	2 mg	OPHTHALMIC	NDA	20 sections
ALREX	HUMAN PRESCRIPTION DRUG LABEL	1	24208-353	SUSPENSION/ DROPS	2 mg	OPHTHALMIC	NDA	20 sections
ALREX	HUMAN PRESCRIPTION DRUG LABEL	1	54868-4277	SUSPENSION/ DROPS	2 mg	OPHTHALMIC	NDA	20 sections
Eysuvis	HUMAN PRESCRIPTION DRUG LABEL	1	71571-333	SUSPENSION/ DROPS	2.50 mg	OPHTHALMIC	NDA	23 sections
Eysuvis	HUMAN PRESCRIPTION DRUG LABEL	1	71571-333	SUSPENSION/ DROPS	2.50 mg	OPHTHALMIC	NDA	23 sections
Inveltys	HUMAN PRESCRIPTION DRUG LABEL	1	71571-121	SUSPENSION	10 mg	TOPICAL	NDA	24 sections
Inveltys	HUMAN PRESCRIPTION DRUG LABEL	1	71571-121	SUSPENSION	10 mg	TOPICAL	NDA	24 sections
LOTEMAX	HUMAN PRESCRIPTION DRUG LABEL	1	24208-299	SUSPENSION/ DROPS	5 mg	OPHTHALMIC	NDA	19 sections
LOTEMAX	HUMAN PRESCRIPTION DRUG LABEL	1	24208-299	SUSPENSION/ DROPS	5 mg	OPHTHALMIC	NDA	19 sections

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