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

Stem definition	Drug id	CAS RN
steroids not used as glucocorticosteroids	2726	76-25-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: nasacort triamcinolone acetonide aristicort allernaze	An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions. Molecular weight: 434.50 Formula: C24H31FO6 CLOGP: 2.21 LIPINSKI: 0 HAC: 6 HDO: 2 TPSA: 93.06 ALOGS: -4.01 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

nasacort
triamcinolone acetonide
aristicort
allernaze

An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.

Molecular weight: 434.50
Formula: C24H31FO6
CLOGP: 2.21
LIPINSKI: 0
HAC: 6
HDO: 2
TPSA: 93.06
ALOGS: -4.01
ROTB: 2

Status: OFP

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

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
CL (Clearance)	9.40 mL/min/kg	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	5.26 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	23 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
t_half (Half-life)	2.40 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Bocci G, Oprea TI, Benet LZ
Vd (Volume of distribution)	1.40 L/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	1 %	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.20 %	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.03 mg/mL	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
Jan. 4, 1960	FDA	APOTHECON

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
Macular degeneration	557.91	11.87	285	40584	24091	63424062
Adrenal insufficiency	283.19	11.87	164	40705	17751	63430402
Dermatitis atopic	264.74	11.87	128	40741	9596	63438557
Injection site atrophy	264.14	11.87	65	40804	578	63447575
Joint destruction	187.59	11.87	88	40781	6164	63441989
Wheelchair user	168.44	11.87	82	40787	6237	63441916
Soft tissue disorder	160.28	11.87	71	40798	4351	63443802
Polyarthritis	157.98	11.87	92	40777	10054	63438099
Obesity	128.07	11.87	125	40744	29827	63418326
Body height below normal	126.46	11.87	49	40820	2134	63446019

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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
Dermatitis atopic	309.29	13.50	106	14008	5241	34937576
Endophthalmitis	236.30	13.50	78	14036	3430	34939387
Non-infectious endophthalmitis	172.89	13.50	33	14081	127	34942690
Dry skin	160.94	13.50	119	13995	31168	34911649
Pruritus	146.54	13.50	229	13885	141752	34801065
Visual acuity reduced	132.33	13.50	82	14032	16067	34926750
Ocular hypertension	118.29	13.50	33	14081	811	34942006
Chorioretinopathy	103.75	13.50	34	14080	1459	34941358
Skin exfoliation	99.49	13.50	85	14029	27347	34915470
Intraocular pressure increased	93.61	13.50	45	14069	5338	34937479

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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
Dermatitis atopic	338.13	11.32	146	43566	9910	79690766
Injection site atrophy	279.48	11.32	61	43651	360	79700316
Non-infectious endophthalmitis	270.96	11.32	57	43655	274	79700402
Endophthalmitis	268.73	11.32	109	43603	6319	79694357
Adrenal insufficiency	268.65	11.32	177	43535	28310	79672366
Joint destruction	199.09	11.32	86	43626	5839	79694837
Toxicity to various agents	172.88	11.32	16	43696	421524	79279152
Dry skin	170.24	11.32	198	43514	67797	79632879
Wheelchair user	164.42	11.32	76	43636	6056	79694620
Ocular hypertension	155.59	11.32	50	43662	1470	79699206

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
CHEBI has role	CHEBI:35472	anti-inflammatory drugs
CHEBI has role	CHEBI:50857	anti-allergic drugs
FDA EPC	N0000175576	Corticosteroid
FDA MoA	N0000175450	Corticosteroid Hormone Receptor Agonists
MeSH PA	D000893	Anti-Inflammatory Agents
MeSH PA	D005938	Glucocorticoids
MeSH PA	D006728	Hormones
MeSH PA	D007155	Immunologic Factors
MeSH PA	D007166	Immunosuppressive 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
Lichen planus	indication	4776004	DOID:9201
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
Dogs	Inflammation and related disorders	Indication
Dogs	Acute arthritis	Indication
Dogs	Allergic disorder	Indication
Dogs	Dermatologic disorders	Indication
Cats	Inflammation and related disorders	Indication
Cats	Acute arthritis	Indication
Cats	Allergic disorder	Indication
Cats	Dermatologic disorders	Indication
Horses	Inflammation and related disorders	Indication

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🐶 Veterinary products

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Product	Applicant	Ingredients
Animax Cream	Fougera Pharmaceuticals Inc.	4
Animax Ointment	Fougera Pharmaceuticals Inc.	4
Derm-Otic Ointment	Zoetis Inc.	4
Derma 4 Ointment	Zoetis Inc.	4
Derma-Vet Cream	Med-Pharmex Inc.	4
DERMA-VET Ointment	Med-Pharmex Inc.	4
Genesis Topical Spray	Virbac AH Inc.	1
Medalone Cream	Med-Pharmex Inc.	1
Panolog Cream	Zoetis Inc.	4
Panolog Ointment	Zoetis Inc.	4

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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
32MG/VIAL	ZILRETTA	PACIRA PHARMS INC	N208845	Oct. 6, 2017	RX	FOR SUSPENSION, EXTENDED RELEASE	INTRA-ARTICULAR	9555048	Aug. 4, 2031	METHOD OF TREATING PAIN OR INFLAMMATION WITH AN INJECTABLE CONTROLLED OR SUSTAINED RELEASE FORMULATION OF TRIAMCINOLONE ACETONIDE
40MG/ML	XIPERE	BAUSCH AND LOMB INC	N211950	Oct. 22, 2021	RX	SUSPENSION	INJECTION	8636713	May 2, 2027	TREATMENT OF MACULAR EDEMA ASSOCIATED WITH UVEITIS
40MG/ML	XIPERE	BAUSCH AND LOMB INC	N211950	Oct. 22, 2021	RX	SUSPENSION	INJECTION	9636332	Nov. 8, 2033	TREATMENT OF MACULAR EDEMA ASSOCIATED WITH UVEITIS
40MG/ML (40MG/ML)	TRIESENCE	NOVARTIS	N022048	Nov. 29, 2007	RX	INJECTABLE	INTRAVITREAL	8211880	March 10, 2029	TREATMENT OF OPHTHALMIC DISORDERS
40MG/ML (40MG/ML)	TRIESENCE	NOVARTIS	N022048	Nov. 29, 2007	RX	INJECTABLE	INTRAVITREAL	8211880	March 10, 2029	VISUALIZATION DURING VITRECTOMY PROCEDURES

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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
40MG/ML	XIPERE	BAUSCH AND LOMB INC	N211950	Oct. 22, 2021	RX	SUSPENSION	INJECTION	Oct. 22, 2024	NEW PRODUCT

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST	EC50	9.30	WOMBAT-PK	CHEMBL
Annexin A1	Cytosolic other	P04083	ANXA1_HUMAN				WOMBAT-PK
Progesterone receptor	Transcription factor		Q690N0_BOVIN		Ki	7.64	DRUG MATRIX

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External reference:

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ID	Source
1TA	PDB_CHEM_ID
002188	NDDF
002189	NDDF
10759	RXNORM
116594009	SNOMEDCT_US
2867	IUPHAR_LIGAND_ID
2967	MMSL
31307	PUBCHEM_CID
395913005	SNOMEDCT_US
4017597	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Allergy Nasal	HUMAN OTC DRUG LABEL	1	0363-0811	SPRAY, METERED	55 ug	NASAL	ANDA	16 sections
Allergy Nasal	HUMAN OTC DRUG LABEL	1	0363-0811	SPRAY, METERED	55 ug	NASAL	ANDA	16 sections
basic care nasal allergy	HUMAN OTC DRUG LABEL	1	0113-7005	SPRAY, METERED	55 ug	NASAL	ANDA	16 sections
Good Sense Nasal Allergy	HUMAN OTC DRUG LABEL	1	0113-0443	SPRAY, METERED	55 ug	NASAL	ANDA	16 sections
Good Sense Nasal Allergy	HUMAN OTC DRUG LABEL	1	0113-0443	SPRAY, METERED	55 ug	NASAL	ANDA	16 sections
KENALOG-10	HUMAN PRESCRIPTION DRUG LABEL	1	0003-0494	INJECTION, SUSPENSION	10 mg	INTRA-ARTICULAR	NDA	22 sections
KENALOG-40	HUMAN PRESCRIPTION DRUG LABEL	1	0003-0293	INJECTION, SUSPENSION	40 mg	INTRAMUSCULAR	NDA	21 sections
KENALOG-40	HUMAN PRESCRIPTION DRUG LABEL	1	0003-0293	INJECTION, SUSPENSION	40 mg	INTRAMUSCULAR	NDA	21 sections
KENALOG-80	HUMAN PRESCRIPTION DRUG LABEL	1	0003-0315	INJECTION, SUSPENSION	80 mg	INTRAMUSCULAR	NDA	21 sections
KENALOG-80	HUMAN PRESCRIPTION DRUG LABEL	1	0003-0315	INJECTION, SUSPENSION	80 mg	INTRAMUSCULAR	NDA	21 sections

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