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

Stem definition	Drug id	CAS RN
corticosteroids, except prednisolone derivatives	4213	50-03-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: hydrocortisone acetate cortisol acetate hydroxycorticosterone acetate	The main glucocorticoid secreted by the ADRENAL CORTEX. Its synthetic counterpart is used, either as an injection or topically, in the treatment of inflammation, allergy, collagen diseases, asthma, adrenocortical deficiency, shock, and some neoplastic conditions Molecular weight: 404.50 Formula: C23H32O6 CLOGP: 2.42 LIPINSKI: 0 HAC: 6 HDO: 2 TPSA: 100.90 ALOGS: -3.84 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

hydrocortisone acetate
cortisol acetate
hydroxycorticosterone acetate

The main glucocorticoid secreted by the ADRENAL CORTEX. Its synthetic counterpart is used, either as an injection or topically, in the treatment of inflammation, allergy, collagen diseases, asthma, adrenocortical deficiency, shock, and some neoplastic conditions

Molecular weight: 404.50
Formula: C23H32O6
CLOGP: 2.42
LIPINSKI: 0
HAC: 6
HDO: 2
TPSA: 100.90
ALOGS: -3.84
ROTB: 4

Status: OFP

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

Drug dosage:

None

ADMET properties:

Property	Value	Reference
S (Water solubility)	0.23 mg/mL	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
Dec. 21, 1951	FDA	MERCK

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
Infusion related reaction	704.00	10.89	1720	152270	243801	63091231
Rheumatoid factor positive	691.62	10.89	935	153055	83471	63251561
Pericarditis	662.37	10.89	1163	152827	130416	63204616
Anti-cyclic citrullinated peptide antibody positive	622.59	10.89	1056	152934	115156	63219876
Wound	586.42	10.89	1251	152739	162012	63173020
Discomfort	531.66	10.89	1221	152769	166153	63168879
Intentional product use issue	515.59	10.89	1028	152962	126864	63208168
Hand deformity	507.25	10.89	1164	152826	158293	63176739
Duodenal ulcer perforation	483.56	10.89	805	153185	86404	63248628
Glossodynia	463.78	10.89	1207	152783	177669	63157363

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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
Intentional product use issue	346.88	10.27	489	64608	59327	34832507
Blood pressure fluctuation	299.77	10.27	298	64799	24951	34866883
Off label use	266.44	10.27	1504	63593	418020	34473814
Adrenal insufficiency	243.47	10.27	205	64892	13842	34877992
Inappropriate schedule of product administration	198.24	10.27	389	64708	61907	34829927
Infusion related reaction	190.70	10.27	349	64748	52708	34839126
Condition aggravated	186.92	10.27	780	64317	191416	34700418
Completed suicide	160.06	10.27	5	65092	98163	34793671
Drug abuse	154.88	10.27	7	65090	99089	34792745
Graft loss	150.33	10.27	58	65039	825	34891009

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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
Intentional product use issue	795.56	9.74	1318	179662	150794	79412614
Infusion related reaction	605.94	9.74	1499	179481	228738	79334670
Completed suicide	520.96	9.74	7	180973	245760	79317648
Pericarditis	450.62	9.74	831	180149	103405	79460003
Rheumatoid factor positive	441.29	9.74	609	180371	59230	79504178
Wound	439.29	9.74	875	180105	115304	79448104
Glossodynia	433.15	9.74	813	180167	102524	79460884
Systemic lupus erythematosus	427.90	9.74	887	180093	120262	79443146
Anti-cyclic citrullinated peptide antibody positive	426.96	9.74	715	180265	82428	79480980
Pemphigus	421.80	9.74	787	180193	98795	79464613

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FDA Adverse Event Reporting System (Pediatric)

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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
Drug-induced liver injury	57.13	40.65	16	195	58	89523
Aspergillus infection	52.53	40.65	16	195	83	89498
Product use issue	42.22	40.65	16	195	175	89406
Hepatotoxicity	41.76	40.65	14	197	103	89478

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Pharmacologic Action:

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Source	Code	Description
CHEBI has role	CHEBI:35472	anti-inflammatory drugs
CHEBI has role	CHEBI:49167	anti-asthmatic drugs
CHEBI has role	CHEBI:50857	anti-allergic drugs
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
CHEBI has role	CHEBI:88188	allergenic drug
FDA EPC	N0000175576	Corticosteroid
FDA MoA	N0000175450	Corticosteroid Hormone Receptor Agonists
MeSH PA	D000893	Anti-Inflammatory 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
Cerebral edema	indication	2032001
Keratitis	indication	5888003	DOID:4677
Berylliosis	indication	8247009	DOID:10322
Psoriasis	indication	9014002	DOID:8893
Ankylosing spondylitis	indication	9631008	DOID:7147
Rheumatic heart disease	indication	23685000
Atopic dermatitis	indication	24079001	DOID:3310
Inflammatory bowel disease	indication	24526004	DOID:0050589
Multiple sclerosis	indication	24700007	DOID:2377
Severe adrenal insufficiency	indication	24867002

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🐶 Veterinary Drug Use

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Species	Use	Relation
Cats	Acute otitis externa	Indication
Cats	Chronic otitis externa	Indication
Cats	Ear canker	Indication
Cats	Inflammatory conditions of the external ear canal	Indication
Cats	Allergy	Indication
Cats	Infectious skin conditions	Indication
Cats	Traumatic skin conditions	Indication
Cats	Prevention of bacterial infections in superficial wounds	Indication
Cats	Prevention of bacterial infections in cuts	Indication
Cats	Prevention of bacterial infections in abrasions	Indication

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🐶 Veterinary products

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Product	Applicant	Ingredients
Amphoderm Ointment	Zoetis Inc.	3
Bacitracin-Neomycin-Polymyxin with Hydrocortisone Acetate Ophthalmic Ointment, Vetropolycin HC Ophthalmic Ointment	Dechra, Ltd.	4
Forte Topical Ointment	Zoetis Inc.	4
Kanfosone Ointment	Zoetis Inc.	3
Kymar Ointment Improved	Intervet Inc.	4
Neo-Cortef Sterile Ointment	Zoetis Inc.	2
Neo-Cortef with Tetracaine	Zoetis Inc.	3

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Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.94	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
Corticosteroid-binding globulin	Secreted	P08185	CBG_HUMAN		Ki	7.55		CHEMBL

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External reference:

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ID	Source
002147	NDDF
002148	NDDF
16602005	SNOMEDCT_US
2500	MMSL
27197	RXNORM
2749	MMSL
38	INN_ID
396458002	SNOMEDCT_US
3X7931PO74	UNII
4017941	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ANUCORT-HC	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0503	SUPPOSITORY	25 mg	RECTAL	unapproved drug other	14 sections
ANUCORT-HC	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0503	SUPPOSITORY	25 mg	RECTAL	unapproved drug other	14 sections
Cortifoam	HUMAN PRESCRIPTION DRUG LABEL	1	0037-6830	AEROSOL, FOAM	1500 mg	TOPICAL	NDA	20 sections
EPIFOAM	HUMAN PRESCRIPTION DRUG LABEL	2	0037-6824	AEROSOL, FOAM	100 mg	TOPICAL	ANDA	20 sections
Hemmorex-HC	HUMAN PRESCRIPTION DRUG LABEL	1	16477-201	SUPPOSITORY	25 mg	RECTAL	unapproved drug other	14 sections
Hemmorex-HC	HUMAN PRESCRIPTION DRUG LABEL	1	16477-202	SUPPOSITORY	30 mg	RECTAL	unapproved drug other	15 sections
Hydrocortisone	HUMAN OTC DRUG LABEL	1	0363-0972	CREAM	1 g	TOPICAL	OTC MONOGRAPH NOT FINAL	15 sections
HYDROCORTISONE	HUMAN OTC DRUG LABEL	1	0498-0801	CREAM	1 g	TOPICAL	OTC monograph not final	13 sections
HYDROCORTISONE	HUMAN OTC DRUG LABEL	1	0498-0801	CREAM	1 g	TOPICAL	OTC monograph not final	13 sections
HYDROCORTISONE	HUMAN OTC DRUG LABEL	1	0924-5632	OINTMENT	1 g	TOPICAL	OTC monograph not final	13 sections

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