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

Stem definition	Drug id	CAS RN
steroids for topical use, acetal derivatives	1204	67-73-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: fluocinolone acetonide fluocinolonacetonid fluocinolone acetonide dihydrate fluocinolone acetonide oil	A glucocorticoid derivative used topically in the treatment of various skin disorders. It is usually employed as a cream, gel, lotion, or ointment. It has also been used topically in the treatment of inflammatory eye, ear, and nose disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p732) Molecular weight: 452.50 Formula: C24H30F2O6 CLOGP: 2.25 LIPINSKI: 0 HAC: 6 HDO: 2 TPSA: 93.06 ALOGS: -3.92 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

fluocinolone acetonide
fluocinolonacetonid
fluocinolone acetonide dihydrate
fluocinolone acetonide oil

A glucocorticoid derivative used topically in the treatment of various skin disorders. It is usually employed as a cream, gel, lotion, or ointment. It has also been used topically in the treatment of inflammatory eye, ear, and nose disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p732)

Molecular weight: 452.50
Formula: C24H30F2O6
CLOGP: 2.25
LIPINSKI: 0
HAC: 6
HDO: 2
TPSA: 93.06
ALOGS: -3.92
ROTB: 2

Status: OFP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Feb. 15, 1963	FDA	MEDIMETRIKS PHARMS

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
Intraocular pressure increased	140.15	27.10	34	2114	6044	63480830
Psoriasis	95.11	27.10	50	2098	86907	63399967
Device dislocation	91.77	27.10	34	2114	25671	63461203
Hypotony of eye	80.79	27.10	12	2136	144	63486730
Product dose omission issue	80.46	27.10	65	2083	234248	63252626
Medical device removal	78.73	27.10	16	2132	1261	63485613
Corneal oedema	59.25	27.10	13	2135	1480	63485394
Implantation complication	57.38	27.10	7	2141	14	63486860
No adverse event	51.49	27.10	26	2122	41379	63445495
Dermatitis atopic	50.46	27.10	17	2131	9707	63477167

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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	175.42	38.94	38	882	5345	34950666
Medical device removal	118.75	38.94	16	904	119	34955892
Device dislocation	91.08	38.94	23	897	6226	34949785
No adverse event	88.27	38.94	30	890	22897	34933114
Vitrectomy	69.05	38.94	10	910	131	34955880
Corneal oedema	57.97	38.94	12	908	1339	34954672
Trabeculectomy	57.66	38.94	7	913	19	34955992
Glaucoma drainage device placement	57.29	38.94	6	914	0	34956011
Cataract operation	52.67	38.94	11	909	1281	34954730
Implantation complication	51.79	38.94	6	914	9	34956002

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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	207.42	26.93	48	2018	9157	79733165
Medical device removal	141.66	26.93	23	2043	672	79741650
Device dislocation	116.30	26.93	38	2028	25932	79716390
No adverse event	99.26	26.93	37	2029	37155	79705167
Vitrectomy	94.54	26.93	14	2052	219	79742103
Product dose omission issue	85.84	26.93	62	2004	247475	79494847
Hypotony of eye	85.50	26.93	13	2053	245	79742077
Corneal oedema	82.59	26.93	18	2048	2602	79739720
Dermatitis atopic	71.55	26.93	21	2045	10035	79732287
Glaucoma	61.36	26.93	22	2044	19739	79722583

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	C05AA10	CARDIOVASCULAR SYSTEM VASOPROTECTIVES AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE Corticosteroids
ATC	D07AC04	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, potent (group III)
ATC	D07BC02	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, COMBINATIONS WITH ANTISEPTICS Corticosteroids, potent, combinations with antiseptics
ATC	D07CC02	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS Corticosteroids, potent, combinations with antibiotics
ATC	S01BA15	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Corticosteroids, plain
ATC	S01CA10	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION Corticosteroids and antiinfectives in combination
ATC	S02BA08	SENSORY ORGANS OTOLOGICALS CORTICOSTEROIDS Corticosteroids
ATC	S02CA05	SENSORY ORGANS OTOLOGICALS CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION Corticosteroids and antiinfectives in combination
CHEBI has role	CHEBI:35472	anti-inflammatory drugs
CHEBI has role	CHEBI:59683	antipruritic drugs

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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
Choroiditis	indication	16553002	DOID:11406
Atopic dermatitis	indication	24079001	DOID:3310
Chloasma	indication	36209000
Contact dermatitis	indication	40275004	DOID:2773
Seborrheic dermatitis	indication	50563003	DOID:8741
Lichen simplex chronicus	indication	53891004
Granuloma annulare	indication	65508009	DOID:3777
Pruritus ani	indication	90446007
Pityriasis simplex	indication	200767005
Discoid lupus erythematosus	indication	200938002

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🐶 Veterinary Drug Use

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Species	Use	Relation
Cats	Pruritus and inflammation associated with acute otitis externa	Indication
Cats	Pruritus and inflammation associated with acute and chronic dermatoses	Indication
Dogs	Pruritus and inflammation associated with superficial acute and chronic dermatoses	Indication
Dogs	Allergic and acute moist dermatoses	Indication
Dogs	Nonspecific dermatoses	Indication
Dogs	Wound infections	Indication

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🐶 Veterinary products

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Product	Applicant	Ingredients
Neo-synalar Cream	Bausch Health US LLC	2
Synalar Cream Veterinary	Bausch Health US LLC	1
Synalar Solution Veterinary	Bausch Health US LLC	1
Synotic Otic Solution	Zoetis Inc.	2
Synsac Solution	Zoetis Inc.	2

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Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.08	acidic
pKa2	11.78	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
0.18MG	YUTIQ	ALIMERA SCIENCES INC	N210331	Oct. 12, 2018	RX	IMPLANT	INTRAVITREAL	7998108	Jan. 12, 2028	A METHOD OF INJECTING AN IMPLANT
EQ 0.3% BASE;0.025%	OTOVEL	LABORATORIOS SALVAT	N208251	April 29, 2016	RX	SOLUTION/DROPS	OTIC	8932610	March 24, 2030	TREATMENT OF ACUTE OTITIS MEDIA

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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	Ki	8.85		DRUG MATRIX	CHEMBL
Progesterone receptor	Transcription factor		Q690N0_BOVIN		Ki	8.48		DRUG MATRIX

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External reference:

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ID	Source
002193	NDDF
011117	NDDF
0CD5FD6S2M	UNII
1046	INN_ID
25126	RXNORM
28426008	SNOMEDCT_US
395977002	SNOMEDCT_US
396059004	SNOMEDCT_US
4018222	VUID
4018222	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Ciprofloxacin and Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	2	42195-128	SOLUTION	0.06 mg	AURICULAR (OTIC)	NDA	26 sections
Ciprofloxacin and Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	2	42195-128	SOLUTION	0.06 mg	AURICULAR (OTIC)	NDA	26 sections
Flac Otic Oil	HUMAN PRESCRIPTION DRUG LABEL	1	39328-079	OIL	0.11 mg	AURICULAR (OTIC)	ANDA	21 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0058	CREAM	0.10 mg	TOPICAL	ANDA	18 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0059	SOLUTION	0.10 mg	TOPICAL	ANDA	18 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0060	CREAM	0.25 mg	TOPICAL	ANDA	18 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0064	OINTMENT	0.25 mg	TOPICAL	ANDA	18 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0222	CREAM	0.25 mg	TOPICAL	ANDA	10 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0222	CREAM	0.25 mg	TOPICAL	ANDA	10 sections
Fluocinolone Acetonide	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0223	CREAM	0.10 mg	TOPICAL	ANDA	10 sections

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