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

Stem definition	Drug id	CAS RN
diazepam derivatives	2015	604-75-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: oxazepam droxacepam durazepam noctazepam tazepam zaxopam	A benzodiazepine used in the treatment of anxiety, alcohol withdrawal, and insomnia. Molecular weight: 286.72 Formula: C15H11ClN2O2 CLOGP: 2.31 LIPINSKI: 0 HAC: 4 HDO: 2 TPSA: 61.69 ALOGS: -3.51 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

oxazepam
droxacepam
durazepam
noctazepam
tazepam
zaxopam

A benzodiazepine used in the treatment of anxiety, alcohol withdrawal, and insomnia.

Molecular weight: 286.72
Formula: C15H11ClN2O2
CLOGP: 2.31
LIPINSKI: 0
HAC: 4
HDO: 2
TPSA: 61.69
ALOGS: -3.51
ROTB: 1

Status: OFP

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

Drug dosage:

Dose	Unit	Route
50	mg	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	97 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
MRTD (Maximum Recommended Therapeutic Daily Dose)	6.98 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
t_half (Half-life)	6.70 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
CL (Clearance)	1.10 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.59 L/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.05 mg/mL	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.04 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
June 4, 1965	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
Toxicity to various agents	1395.16	13.89	1179	38105	246071	63203667
Depressed level of consciousness	1033.96	13.89	579	38705	61499	63388239
Coma	945.06	13.89	553	38731	63811	63385927
Orthostatic hypotension	937.38	13.89	454	38830	35706	63414032
Intentional overdose	882.78	13.89	557	38727	73595	63376143
Sedation complication	856.13	13.89	322	38962	13500	63436238
Sedation	854.16	13.89	436	38848	38373	63411365
Poisoning deliberate	822.86	13.89	296	38988	10922	63438816
Creatinine renal clearance decreased	814.83	13.89	325	38959	15983	63433755
Cognitive disorder	731.71	13.89	446	38838	55369	63394369

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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
Toxicity to various agents	1061.80	15.19	998	25037	199364	34731532
Drug abuse	796.39	15.19	628	25407	98468	34832428
Coma	687.70	15.19	426	25609	45252	34885644
Poisoning deliberate	399.28	15.19	167	25868	7677	34923219
Miosis	308.95	15.19	148	25887	9387	34921509
Drug dependence	307.12	15.19	203	25832	24014	34906882
Asphyxia	306.38	15.19	133	25902	6702	34924194
Overdose	220.96	15.19	304	25731	90755	34840141
Somnolence	220.22	15.19	337	25698	110779	34820117
Depressed level of consciousness	216.33	15.19	209	25826	42632	34888264

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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
Toxicity to various agents	2250.33	12.80	2110	57320	419430	79265528
Coma	1571.55	12.80	961	58469	99688	79585270
Poisoning deliberate	1157.57	12.80	459	58971	18369	79666589
Depressed level of consciousness	1092.58	12.80	754	58676	95898	79589060
Drug abuse	988.37	12.80	879	58551	161812	79523146
Sedation complication	798.62	12.80	334	59096	15335	79669623
Sedation	776.83	12.80	483	58947	51412	79633546
Orthostatic hypotension	741.81	12.80	483	58947	55681	79629277
Creatinine renal clearance decreased	739.84	12.80	335	59095	18667	79666291
Intentional overdose	659.61	12.80	581	58849	105379	79579579

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N05BA04	NERVOUS SYSTEM PSYCHOLEPTICS ANXIOLYTICS Benzodiazepine derivatives
CHEBI has role	CHEBI:35474	anti-anxiety agents
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:78298	environmental contaminants
FDA CS	M0002356	Benzodiazepines
FDA EPC	N0000175694	Benzodiazepine
MeSH PA	D014151	Anti-Anxiety Agents
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D018682	GABA 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
Alcohol withdrawal delirium	indication	8635005
Anxiety	indication	48694002
Suicidal thoughts	contraindication	6471006
Disorder of lung	contraindication	19829001	DOID:850
Borderline personality disorder	contraindication	20010003	DOID:10930
Alcohol intoxication	contraindication	25702006
Shock	contraindication	27942005
Depressive disorder	contraindication	35489007
Low blood pressure	contraindication	45007003
Substance abuse	contraindication	66214007

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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	9.41	acidic
pKa2	11.87	acidic
pKa3	1.83	Basic

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
GABA-A receptor alpha-1/beta-3/gamma-2	Ion channel	P14867 P18507 P28472	GBRA1_HUMAN GBRG2_HUMAN GBRB3_HUMAN	POSITIVE ALLOSTERIC MODULATOR	IC50	7.75		WOMBAT-PK	CHEMBL

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External reference:

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ID	Source
001462	NDDF
1507	INN_ID
387455006	SNOMEDCT_US
4018020	VUID
4018020	VANDF
4493	MMSL
4616	PUBCHEM_CID
5211	MMSL
6GOW6DWN2A	UNII
7253	IUPHAR_LIGAND_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Oxazepam	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2067	CAPSULE, GELATIN COATED	10 mg	ORAL	ANDA	21 sections
Oxazepam	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2067	CAPSULE, GELATIN COATED	10 mg	ORAL	ANDA	21 sections
Oxazepam	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2067	CAPSULE, GELATIN COATED	10 mg	ORAL	ANDA	21 sections
Oxazepam	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2069	CAPSULE, GELATIN COATED	15 mg	ORAL	ANDA	21 sections
Oxazepam	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2069	CAPSULE, GELATIN COATED	15 mg	ORAL	ANDA	21 sections
Oxazepam	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2069	CAPSULE, GELATIN COATED	15 mg	ORAL	ANDA	21 sections
Oxazepam	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2073	CAPSULE, GELATIN COATED	30 mg	ORAL	ANDA	21 sections
Oxazepam	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2073	CAPSULE, GELATIN COATED	30 mg	ORAL	ANDA	21 sections
Oxazepam	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2073	CAPSULE, GELATIN COATED	30 mg	ORAL	ANDA	21 sections
OXAZEPAM	HUMAN PRESCRIPTION DRUG LABEL	1	16590-304	CAPSULE	15 mg	ORAL	ANDA	13 sections

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