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

Stem definition	Drug id	CAS RN
prednisone and prednisolone derivatives	2245	50-24-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: prednisolone prenolone deltahydrocortisone hydroretrocortin hydroretrocortine metacortandralone	A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states. Molecular weight: 360.45 Formula: C21H28O5 CLOGP: 1.42 LIPINSKI: 0 HAC: 5 HDO: 3 TPSA: 94.83 ALOGS: -3.18 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

prednisolone
prenolone
deltahydrocortisone
hydroretrocortin
hydroretrocortine
metacortandralone

A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states.

Molecular weight: 360.45
Formula: C21H28O5
CLOGP: 1.42
LIPINSKI: 0
HAC: 5
HDO: 3
TPSA: 94.83
ALOGS: -3.18
ROTB: 2

Status: OFP

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

Drug dosage:

Dose	Unit	Route
10	mg	O
10	mg	P

ADMET properties:

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Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	9.24 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	82 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
t_half (Half-life)	3.40 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2.90 mL/min/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	16 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	0.86 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.25 %	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.22 mg/mL	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
June 21, 1955	FDA

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
Pneumocystis jirovecii pneumonia	1305.56	9.56	810	241200	16104	63230908
Cytomegalovirus infection	1017.32	9.56	753	241257	20199	63226813
Fatigue	757.21	9.56	1400	240610	886628	62360384
Pain	633.60	9.56	1164	240846	739464	62507548
Sepsis	533.83	9.56	1534	240476	151589	63095423
Product dose omission issue	502.38	9.56	136	241874	234177	63012835
Interstitial lung disease	451.84	9.56	831	241179	61077	63185935
Lymphoproliferative disorder	432.16	9.56	221	241789	2969	63244043
Completed suicide	421.35	9.56	36	241974	145637	63101375
Haemophagocytic lymphohistiocytosis	384.12	9.56	321	241689	10306	63236706

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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
Cytomegalovirus infection	1000.95	10.58	979	201661	25156	34729135
Pneumocystis jirovecii pneumonia	878.21	10.58	803	201837	18907	34735384
Drug abuse	456.61	10.58	30	202610	99066	34655225
Transplant rejection	447.31	10.58	414	202226	9897	34744394
Post transplant lymphoproliferative disorder	431.42	10.58	334	202306	6194	34748097
Completed suicide	418.29	10.58	42	202598	98126	34656165
Death	412.04	10.58	1079	201561	396970	34357321
Product dose omission issue	405.00	10.58	98	202542	119613	34634678
Product use in unapproved indication	394.37	10.58	1534	201106	115965	34638326
Hepatitis B	362.83	10.58	291	202349	5692	34748599

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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
Cytomegalovirus infection	1895.12	9.65	1605	384576	41039	79317168
Pneumocystis jirovecii pneumonia	1831.94	9.65	1406	384775	31102	79327105
Completed suicide	923.48	9.65	70	386111	245697	79112510
Fatigue	802.97	9.65	2107	384074	927620	78430587
Product use in unapproved indication	738.38	9.65	2775	383406	247584	79110623
Pain	692.73	9.65	1487	384694	702315	78655892
Product dose omission issue	682.62	9.65	178	386003	247359	79110848
Post transplant lymphoproliferative disorder	661.34	9.65	503	385678	10961	79347246
Interstitial lung disease	623.22	9.65	1557	384624	111043	79247164
Bronchopulmonary aspergillosis	619.83	9.65	647	385534	21647	79336560

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A01AC04	ALIMENTARY TRACT AND METABOLISM STOMATOLOGICAL PREPARATIONS STOMATOLOGICAL PREPARATIONS Corticosteroids for local oral treatment
ATC	A01AC54	ALIMENTARY TRACT AND METABOLISM STOMATOLOGICAL PREPARATIONS STOMATOLOGICAL PREPARATIONS Corticosteroids for local oral treatment
ATC	A07EA01	ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS INTESTINAL ANTIINFLAMMATORY AGENTS Corticosteroids acting locally
ATC	C05AA04	CARDIOVASCULAR SYSTEM VASOPROTECTIVES AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE Corticosteroids
ATC	D07AA03	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, weak (group I)
ATC	D07BA01	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, COMBINATIONS WITH ANTISEPTICS Corticosteroids, weak, combinations with antiseptics
ATC	D07CA03	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS Corticosteroids, weak, combinations with antibiotics
ATC	D07XA02	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, OTHER COMBINATIONS Corticosteroids, weak, other combinations
ATC	H02AB06	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CORTICOSTEROIDS FOR SYSTEMIC USE CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN Glucocorticoids
ATC	R01AD02	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids

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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
Disorder of musculoskeletal system	indication	928000	DOID:17
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
Cyclitis	indication	17657000
Rheumatic heart disease	indication	23685000
Atopic dermatitis	indication	24079001	DOID:3310
Inflammatory bowel disease	indication	24526004	DOID:0050589

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🐶 Veterinary Drug Use

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Species	Use	Relation
Cats	Infectious allergic keratitis	Indication
Cats	Traumatic keratitis	Indication
Cats	Conjunctivitis	Indication
Cats	Otitis externa	Indication
Cats	Chronic otitis externa	Indication
Dogs	Itching	Indication
Dogs	Inflammation commonly associated with most skin disorders	Indication
Dogs	Adjunctive therapy in various cough conditions	Indication
Dogs	Acute or chronic bacterial infections	Indication

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🐶 Veterinary products

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Product	Applicant	Ingredients
Delta Albaplex 3x Tablets, Delta Albaplex Tablets	Zoetis Inc.	3
PrednisTab	Lloyd Inc.	1
Temaril-P Spansule Capsule No. 1, Temaril-P Spansule Capsule No. 2	Zoetis Inc.	2
Temaril-P Tablets	Zoetis Inc.	2

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Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.18	acidic
pKa2	12.91	acidic

Orange Book patent data (new drug applications)

None

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
5MG	PREDNISOLONE	AUROBINDO PHARMA LTD	A215673	March 17, 2023	RX	TABLET	ORAL	Nov. 18, 2023	COMPETITIVE GENERIC THERAPY

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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	7.80	WOMBAT-PK	CHEMBL
Annexin A1	Cytosolic other	P04083	ANXA1_HUMAN				WOMBAT-PK
Mineralocorticoid receptor	Nuclear hormone receptor	P08235	MCR_HUMAN		Ki	9.54	CHEMBL
Androgen receptor	Nuclear hormone receptor	P10275	ANDR_HUMAN		Ki	5.60	CHEMBL
Corticosteroid-binding globulin	Secreted	P08185	CBG_HUMAN		Ki	7.51	CHEMBL
Interleukin-6	Cytokine	P05231	IL6_HUMAN		IC50	8.38	CHEMBL
G-protein coupled bile acid receptor 1	GPCR	Q8TDU6	GPBAR_HUMAN		IC50	6.60	CHEMBL
Glutamine synthetase	Enzyme	P15104	GLNA_HUMAN		EC50	7.49	CHEMBL
Disintegrin and metalloproteinase domain-containing protein 17	Unclassified	P78536	ADA17_HUMAN		IC50	7.83	CHEMBL
Progesterone receptor	Nuclear hormone receptor	P06401	PRGR_HUMAN		IC50	5.68	CHEMBL

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External reference:

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ID	Source
TUA	PDB_CHEM_ID
002155	NDDF
116601002	SNOMEDCT_US
2866	IUPHAR_LIGAND_ID
4017988	VUID
4017988	VANDF
52388000	SNOMEDCT_US
5347	MMSL
535	INN_ID
5755	PUBCHEM_CID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
CAMBISON	HUMAN OTC DRUG LABEL	2	72689-0016	OINTMENT	4 mg	TOPICAL	unapproved drug other	7 sections
MILLIPRED	HUMAN PRESCRIPTION DRUG LABEL	1	23594-505	TABLET	5 mg	ORAL	ANDA	13 sections
PrednisoLONE	HUMAN PRESCRIPTION DRUG LABEL	1	0527-5406	SYRUP	15 mg	ORAL	ANDA	14 sections
PrednisoLONE	HUMAN PRESCRIPTION DRUG LABEL	1	0527-5406	SYRUP	15 mg	ORAL	ANDA	14 sections
PrednisoLONE	HUMAN PRESCRIPTION DRUG LABEL	1	0527-5406	SYRUP	15 mg	ORAL	ANDA	14 sections
Prednisolone	HUMAN PRESCRIPTION DRUG LABEL	1	12634-686	SOLUTION	15 mg	ORAL	ANDA	11 sections
Prednisolone	HUMAN PRESCRIPTION DRUG LABEL	1	16590-291	SOLUTION	15 mg	ORAL	ANDA	11 sections
Prednisolone	HUMAN PRESCRIPTION DRUG LABEL	1	21695-365	SOLUTION	15 mg	ORAL	ANDA	12 sections
Prednisolone	HUMAN PRESCRIPTION DRUG LABEL	1	33261-475	SOLUTION	15 mg	ORAL	ANDA	12 sections
Prednisolone	HUMAN PRESCRIPTION DRUG LABEL	1	50090-0655	SOLUTION	15 mg	ORAL	ANDA	12 sections

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