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

Stem definition	Drug id	CAS RN
	1201	3385-03-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: flunisolide nasalide bronalide	corticosteroid prescribed as treatment for allergic rhinitis Molecular weight: 434.50 Formula: C24H31FO6 CLOGP: 2.41 LIPINSKI: 0 HAC: 6 HDO: 2 TPSA: 93.06 ALOGS: -4.07 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

flunisolide
nasalide
bronalide

corticosteroid prescribed as treatment for allergic rhinitis

Molecular weight: 434.50
Formula: C24H31FO6
CLOGP: 2.41
LIPINSKI: 0
HAC: 6
HDO: 2
TPSA: 93.06
ALOGS: -4.07
ROTB: 2

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.15	mg	N
1	mg	Inhal.aerosol

ADMET properties:

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Property	Value	Reference
CL (Clearance)	9.50 mL/min/kg	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	6.70 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
t_half (Half-life)	1.68 hours	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	1.08 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.24 %	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.07 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

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Approvals:

Date	Agency	Company	Orphan
Sept. 24, 1981	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
Nasal discomfort	54.33	28.16	11	382	4749	63483880

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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
Nasal discomfort	54.00	22.08	13	1616	1615	34953687
International normalised ratio increased	26.40	22.08	20	1609	47307	34907995
Throat irritation	23.68	22.08	11	1618	10574	34944728

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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
Nasal discomfort	95.32	22.80	22	1542	5461	79737363
Dehydration	29.63	22.80	30	1534	248157	79494667

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	R01AD04	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids
ATC	R03BA03	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS Glucocorticoids
CHEBI has role	CHEBI:35472	anti-inflammatory drugs
CHEBI has role	CHEBI:35705	immunosuppressive agents
CHEBI has role	CHEBI:49167	anti-asthmatic drugs
MeSH PA	D018927	Anti-Asthmatic Agents
MeSH PA	D000893	Anti-Inflammatory Agents
MeSH PA	D019141	Respiratory System 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
Allergic rhinitis	indication	61582004
Asthma	indication	195967001	DOID:2841
Asthma management	indication	406162001
Allergic Rhinitis Prevention	indication
Chronic Non-Allergic Rhinitis	indication
Severe chronic obstructive pulmonary disease	off-label use	313299006
Mycosis	contraindication	3218000	DOID:1564
Inactive tuberculosis	contraindication	11999007
Epistaxis	contraindication	12441001
Measles	contraindication	14189004	DOID:8622

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.78	acidic
pKa2	12.78	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	EC50	9.10		WOMBAT-PK	CHEMBL
Progesterone receptor	Transcription factor		Q690N0_BOVIN		Ki	7.33		DRUG MATRIX

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External reference:

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ID	Source
002195	NDDF
116588001	SNOMEDCT_US
2119	MMSL
218620	RXNORM
4018433	VUID
4018433	VANDF
43033	MMSL
43879000	SNOMEDCT_US
4737	MMSL
7076	IUPHAR_LIGAND_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Flunisolide	HUMAN PRESCRIPTION DRUG LABEL	1	24208-344	SOLUTION	0.25 mg	NASAL	ANDA	13 sections
Flunisolide	HUMAN PRESCRIPTION DRUG LABEL	1	50742-317	SOLUTION	0.25 mg	NASAL	ANDA	20 sections
Flunisolide	HUMAN PRESCRIPTION DRUG LABEL	1	54868-4799	SOLUTION	0.25 mg	NASAL	ANDA	18 sections
Flunisolide	Human Prescription Drug Label	1	64980-510	SPRAY, METERED	0.25 mg	NASAL	ANDA	19 sections
Flunisolide	HUMAN PRESCRIPTION DRUG LABEL	1	70518-0671	SOLUTION	0.25 mg	NASAL	ANDA	17 sections

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