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

Stem definition	Drug id	CAS RN
prednisone and prednisolone derivatives	3142	23674-86-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: difluprednate durezol	Molecular weight: 508.56 Formula: C27H34F2O7 CLOGP: 3.44 LIPINSKI: 1 HAC: 7 HDO: 1 TPSA: 106.97 ALOGS: -4.72 ROTB: 8 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

difluprednate
durezol

Molecular weight: 508.56
Formula: C27H34F2O7
CLOGP: 3.44
LIPINSKI: 1
HAC: 7
HDO: 1
TPSA: 106.97
ALOGS: -4.72
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
June 23, 2008	FDA	ALCON PHARMS LTD

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
Cataract	117.54	25.53	51	2138	57002	63429831
Eye pain	99.34	25.53	39	2150	33815	63453018
Endophthalmitis	92.19	25.53	22	2167	3570	63483263
Uveitis	85.19	25.53	27	2162	12526	63474307
Vision blurred	70.05	25.53	42	2147	91882	63394951
Eye irritation	66.83	25.53	26	2163	21945	63464888
Visual impairment	62.81	25.53	38	2151	84408	63402425
Intraocular pressure increased	62.44	25.53	18	2171	6060	63480773
Eye inflammation	59.39	25.53	17	2172	5582	63481251
Corneal oedema	53.50	25.53	12	2177	1481	63485352

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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
Intraocular pressure increased	102.14	27.05	26	1218	5357	34950330
Corneal oedema	77.07	27.05	16	1228	1335	34954352
Toxic anterior segment syndrome	61.79	27.05	13	1231	1156	34954531
Eye pain	55.27	27.05	20	1224	13442	34942245
Eye irritation	49.74	27.05	16	1228	7545	34948142
Anterior chamber cell	49.67	27.05	9	1235	366	34955321
Cataract	48.67	27.05	22	1222	26164	34929523
Visual impairment	47.94	27.05	24	1220	35778	34919909
Product quality issue	40.39	27.05	17	1227	17018	34938669
Eye inflammation	38.54	27.05	10	1234	2208	34953479

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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
Intraocular pressure increased	131.17	23.41	35	2635	9170	79732548
Cataract	114.71	23.41	51	2619	62069	79679649
Endophthalmitis	113.57	23.41	29	2641	6399	79735319
Corneal oedema	110.87	23.41	24	2646	2596	79739122
Anterior chamber cell	89.89	23.41	17	2653	932	79740786
Toxic anterior segment syndrome	87.68	23.41	20	2650	2744	79738974
Visual impairment	65.84	23.41	40	2630	92091	79649627
Anterior chamber fibrin	64.39	23.41	10	2660	166	79741552
Eye inflammation	57.59	23.41	17	2653	6396	79735322
Uveitis	48.47	23.41	19	2651	16811	79724907

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	D07AC19	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, potent (group III)
MeSH PA	D005938	Glucocorticoids
MeSH PA	D006728	Hormones

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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
Post-Op Ocular Inflammation	indication
Postoperative Ocular Pain	indication
Cyclitis	off-label use	17657000
Iritis	off-label use	65074000	DOID:1406
Iridocyclitis	off-label use	77971008
Uveitis	off-label use	128473001	DOID:13141
Allergic conjunctivitis	off-label use	473460002	DOID:11204
Ocular hypertension	contraindication	4210003	DOID:9282
Herpes simplex dendritic keratitis	contraindication	29943008
Tuberculosis of eye	contraindication	49107007

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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	11.49	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

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				CHEMBL	CHEMBL

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External reference:

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ID	Source
005778	NDDF
146969	MMSL
22956	MMSL
23043	RXNORM
2652	INN_ID
350413	MMSL
4027694	VUID
4027694	VANDF
438200007	SNOMEDCT_US
440063000	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
DIFLUPREDNATE	HUMAN PRESCRIPTION DRUG LABEL	1	69097-341	EMULSION	0.50 mg	OPHTHALMIC	ANDA	20 sections
Difluprednate	HUMAN PRESCRIPTION DRUG LABEL	1	69238-1380	EMULSION	0.50 mg	OPHTHALMIC	ANDA	23 sections
Difluprednate	HUMAN PRESCRIPTION DRUG LABEL	1	69238-1380	EMULSION	0.50 mg	OPHTHALMIC	ANDA	23 sections
DIFLUPREDNATE	HUMAN PRESCRIPTION DRUG LABEL	1	76282-708	EMULSION	0.50 mg	OPHTHALMIC	ANDA	20 sections
Difluprednate Ophthalmic	HUMAN PRESCRIPTION DRUG LABEL	1	0781-6000	EMULSION	0.50 mg	OPHTHALMIC	NDA authorized generic	21 sections
Difluprednate Ophthalmic	HUMAN PRESCRIPTION DRUG LABEL	1	0781-6000	EMULSION	0.50 mg	OPHTHALMIC	NDA authorized generic	21 sections
Difluprednate Ophthalmic Emulsion	HUMAN PRESCRIPTION DRUG LABEL	1	43598-588	EMULSION	0.50 mg	OPHTHALMIC	ANDA	23 sections
DUREZOL	HUMAN PRESCRIPTION DRUG LABEL	1	0065-9240	EMULSION	0.50 mg	OPHTHALMIC	NDA	23 sections
DUREZOL	HUMAN PRESCRIPTION DRUG LABEL	1	0065-9240	EMULSION	0.50 mg	OPHTHALMIC	NDA	23 sections
DUREZOL	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0862	EMULSION	0.50 mg	OPHTHALMIC	NDA	23 sections

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