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

Stem definition	Drug id	CAS RN
prednisone and prednisolone derivatives	1768	83-43-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: methylprednisolone medralone metilbetasone	A PREDNISOLONE derivative with similar anti-inflammatory action. Molecular weight: 374.48 Formula: C22H30O5 CLOGP: 1.74 LIPINSKI: 0 HAC: 5 HDO: 3 TPSA: 94.83 ALOGS: -3.54 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

methylprednisolone
medralone
metilbetasone

A PREDNISOLONE derivative with similar anti-inflammatory action.

Molecular weight: 374.48
Formula: C22H30O5
CLOGP: 1.74
LIPINSKI: 0
HAC: 5
HDO: 3
TPSA: 94.83
ALOGS: -3.54
ROTB: 2

Status: OFP

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

Drug dosage:

Dose	Unit	Route
7.50	mg	O
20	mg	P

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	82 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance)	6.10 mL/min/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	4.90 %	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	2.30 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Bocci G, Oprea TI, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose)	11.14 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	1.20 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.23 %	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.12 mg/mL	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
Oct. 24, 1957	FDA	PHARMACIA AND UPJOHN

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
Cytomegalovirus infection	821.18	9.53	605	192476	20347	63275594
Off label use	578.67	9.53	3762	189319	670700	62625241
Glossodynia	405.53	9.53	38	193043	178838	63117103
Product use in unapproved indication	396.57	9.53	1322	191759	177758	63118183
Blood pressure fluctuation	389.33	9.53	585	192496	45732	63250209
Drug ineffective for unapproved indication	387.93	9.53	498	192583	33565	63262376
Completed suicide	374.35	9.53	16	193065	145657	63150284
Transplant rejection	340.69	9.53	274	192807	10506	63285435
Pemphigus	321.90	9.53	81	193000	183645	63112296
Abdominal discomfort	295.73	9.53	324	192757	320561	62975380

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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
Off label use	1078.85	10.36	3583	119988	415941	34417419
Cytomegalovirus infection	885.45	10.36	736	122835	25399	34807961
Product use in unapproved indication	523.39	10.36	1230	122341	116269	34717091
Drug ineffective for unapproved indication	517.28	10.36	522	123049	23193	34810167
Drug ineffective	443.84	10.36	2940	120631	453811	34379549
Aspergillus infection	351.60	10.36	314	123257	11940	34821420
Pneumocystis jirovecii pneumonia	348.35	10.36	388	123183	19322	34814038
Death	335.92	10.36	558	123013	397491	34435869
Bronchopulmonary aspergillosis	329.37	10.36	328	123243	14331	34819029
Post transplant lymphoproliferative disorder	324.39	10.36	231	123340	6297	34827063

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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
Off label use	1604.26	9.44	7000	281815	900215	78555358
Cytomegalovirus infection	1520.34	9.44	1250	287565	41394	79414179
Product use in unapproved indication	956.85	9.44	2510	286305	247849	79207724
Drug ineffective for unapproved indication	830.84	9.44	976	287839	50262	79405311
Completed suicide	730.38	9.44	39	288776	245728	79209845
Drug ineffective	690.61	9.44	6438	282377	1074475	78381098
Aspergillus infection	609.15	9.44	526	288289	18635	79436938
Bronchopulmonary aspergillosis	567.27	9.44	540	288275	21754	79433819
Transplant rejection	552.91	9.44	501	288314	18936	79436637
Pneumocystis jirovecii pneumonia	491.97	9.44	598	288217	31910	79423663

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	D07AA01	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, weak (group I)
ATC	D07CA02	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS Corticosteroids, weak, combinations with antibiotics
ATC	D10AA02	DERMATOLOGICALS ANTI-ACNE PREPARATIONS ANTI-ACNE PREPARATIONS FOR TOPICAL USE Corticosteroids, combinations for treatment of acne
ATC	H02AB04	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CORTICOSTEROIDS FOR SYSTEMIC USE CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN Glucocorticoids
ATC	H02BX01	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CORTICOSTEROIDS FOR SYSTEMIC USE CORTICOSTEROIDS FOR SYSTEMIC USE, COMBINATIONS Corticosteroids for systemic use, combinations
ATC	S01CA08	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION Corticosteroids and antiinfectives in combination
ATC	S03CA07	SENSORY ORGANS OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION Corticosteroids and antiinfectives in combination
CHEBI has role	CHEBI:35472	anti-inflammatory drugs
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:37962	adrenergic 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
Disorder of musculoskeletal system	indication	928000	DOID:17
Cerebral edema	indication	2032001
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	Inflammation and related disorders	Indication
Cats	Allergic and dermatologic disorders	Indication
Cats	Supportive therapy to antibacterial treatment of severe infections	Indication
Dogs	Inflammation and related disorders	Indication
Dogs	Allergic and dermatologic disorders	Indication
Dogs	Supportive therapy to antibacterial treatment of severe infections	Indication
Horses	Inflammation and related disorders	Indication

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🐶 Veterinary products

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Product	Applicant	Ingredients
Cortaba Tablets	Zoetis Inc.	2
Medrol Tablets	Zoetis Inc.	1
Methylprednisolene Tablets	Cronus Pharma Specialities India Private Limited	1

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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	12.89	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])	Bioact source	MoA source
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST	EC50	8.50	WOMBAT-PK	CHEMBL
Annexin A1	Cytosolic other	P04083	ANXA1_HUMAN				WOMBAT-PK
Short transient receptor potential channel 5	Ion channel	Q9UL62	TRPC5_HUMAN	ACTIVATOR	EC50	4.92	IUPHAR
Androgen receptor	Transcription factor		ANDR_RAT		Ki	4.75	DRUG MATRIX

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External reference:

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ID	Source
002160	NDDF
1041	MMSL
116593003	SNOMEDCT_US
27242001	SNOMEDCT_US
4018068	VUID
4018068	VANDF
5093	MMSL
6741	PUBCHEM_CID
6902	RXNORM
7088	IUPHAR_LIGAND_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Medrol	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0020	TABLET	2 mg	ORAL	NDA	16 sections
Medrol	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0020	TABLET	2 mg	ORAL	NDA	16 sections
Medrol	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0022	TABLET	8 mg	ORAL	NDA	16 sections
Medrol	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0022	TABLET	8 mg	ORAL	NDA	16 sections
Medrol	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0049	TABLET	2 mg	ORAL	NDA	16 sections
Medrol	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0049	TABLET	2 mg	ORAL	NDA	16 sections
Medrol	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0056	TABLET	4 mg	ORAL	NDA	16 sections
Medrol	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0056	TABLET	4 mg	ORAL	NDA	16 sections
Medrol	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0073	TABLET	16 mg	ORAL	NDA	16 sections
Medrol	HUMAN PRESCRIPTION DRUG LABEL	1	0009-0073	TABLET	16 mg	ORAL	NDA	16 sections

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