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

Stem definition	Drug id	CAS RN
prednisone and prednisolone derivatives	348	378-44-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: betamethasone betadexamethasone betametasone betamethazone bethamethasone	A glucocorticoid given orally, parenterally, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. Its lack of mineralocorticoid properties makes betamethasone particularly suitable for treating cerebral edema and congenital adrenal hyperplasia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p724) Molecular weight: 392.47 Formula: C22H29FO5 CLOGP: 1.78 LIPINSKI: 0 HAC: 5 HDO: 3 TPSA: 94.83 ALOGS: -3.89 ROTB: 2 Status: OFM Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

betamethasone
betadexamethasone
betametasone
betamethazone
bethamethasone

A glucocorticoid given orally, parenterally, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. Its lack of mineralocorticoid properties makes betamethasone particularly suitable for treating cerebral edema and congenital adrenal hyperplasia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p724)

Molecular weight: 392.47
Formula: C22H29FO5
CLOGP: 1.78
LIPINSKI: 0
HAC: 5
HDO: 3
TPSA: 94.83
ALOGS: -3.89
ROTB: 2

Status: OFM

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

Drug dosage:

Dose	Unit	Route
1.50	mg	O
1.50	mg	P
0.40	mg	P
0.40	mg	N

ADMET properties:

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Property	Value	Reference
t_half (Half-life)	5.60 hours	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	4.80 %	Benet LZ, Broccatelli F, Oprea TI
CL (Clearance)	2.80 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	1.30 L/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
BA (Bioavailability)	0.72 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.38 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
fu (Fraction unbound in plasma)	0.36 %	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.06 mg/mL	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
April 17, 1961	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
Premature delivery	1980.90	13.98	614	18775	29667	63439966
Premature baby	1128.54	13.98	366	19023	20369	63449264
Maternal exposure during pregnancy	1065.84	13.98	720	18669	219342	63250291
Low birth weight baby	757.39	13.98	211	19178	6918	63462715
Exposure during pregnancy	668.64	13.98	474	18915	155073	63314560
Foetal exposure during pregnancy	647.94	13.98	273	19116	31689	63437944
Normal labour	393.73	13.98	76	19313	441	63469192
Delivery	349.45	13.98	82	19307	1321	63468312
Macular degeneration	299.45	13.98	147	19242	24229	63445404
Product use in unapproved indication	263.46	13.98	298	19091	178782	63290851

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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
Premature baby	960.65	19.21	338	13021	19295	34924277
Low birth weight baby	597.06	19.21	189	13170	7716	34935856
Foetal exposure during pregnancy	550.19	19.21	275	13084	37826	34905746
Appendicolith	419.55	19.21	148	13211	8453	34935119
Appendicitis	348.06	19.21	150	13209	14657	34928915
Drug eruption	311.66	19.21	152	13207	19746	34923826
Stress	296.30	19.21	169	13190	30178	34913394
Cardiogenic shock	269.97	19.21	152	13207	26466	34917106
Stomatitis	225.29	19.21	161	13198	42353	34901219
Hepatic function abnormal	214.62	19.21	159	13200	44204	34899368

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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
Premature delivery	1370.27	13.59	444	25564	23023	79695357
Maternal exposure during pregnancy	792.07	13.59	514	25494	136024	79582356
Exposure during pregnancy	643.83	13.59	404	25604	100728	79617652
Appendicolith	439.02	13.59	147	25861	8404	79709976
Appendicitis	318.54	13.59	149	25859	20645	79697735
Drug eruption	245.65	13.59	162	25846	43773	79674607
Cardiogenic shock	218.56	13.59	148	25860	41766	79676614
Premature labour	206.50	13.59	84	25924	8306	79710074
Stress	204.72	13.59	185	25823	79427	79638953
Hepatic function abnormal	192.14	13.59	172	25836	72935	79645445

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A07EA04	ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS INTESTINAL ANTIINFLAMMATORY AGENTS Corticosteroids acting locally
ATC	C05AA05	CARDIOVASCULAR SYSTEM VASOPROTECTIVES AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE Corticosteroids
ATC	D07AC01	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, PLAIN Corticosteroids, potent (group III)
ATC	D07BC01	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, COMBINATIONS WITH ANTISEPTICS Corticosteroids, potent, combinations with antiseptics
ATC	D07CC01	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS Corticosteroids, potent, combinations with antibiotics
ATC	D07XC01	DERMATOLOGICALS CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS CORTICOSTEROIDS, OTHER COMBINATIONS Corticosteroids, potent, other combinations
ATC	H02AB01	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CORTICOSTEROIDS FOR SYSTEMIC USE CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN Glucocorticoids
ATC	R01AD06	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids
ATC	R03BA04	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS Glucocorticoids
ATC	S01BA06	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Corticosteroids, plain

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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
Tinea pedis	indication	6020002	DOID:12403
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

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🐶 Veterinary Drug Use

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🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.06	acidic
pKa2	12.45	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

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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	IC50	8.07		WOMBAT-PK	CHEMBL
Annexin A1	Cytosolic other	P04083	ANXA1_HUMAN					WOMBAT-PK

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External reference:

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ID	Source
002168	NDDF
10006	MMSL
1045	INN_ID
116571008	SNOMEDCT_US
1514	RXNORM
29896003	SNOMEDCT_US
4018644	VUID
4018644	VANDF
4270	MMSL
7061	IUPHAR_LIGAND_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
DR. THROWERS BETA	HUMAN PRESCRIPTION DRUG LABEL	1	69299-202	OINTMENT	0.05 g	TOPICAL	unapproved drug other	4 sections

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