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

Stem definition	Drug id	CAS RN
diazepam derivatives	2585	846-50-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: temazepam (RS)-Temazepam levanxene levanxol	A benzodiazepine that acts as a GAMMA-AMINOBUTYRIC ACID modulator and anti-anxiety agent. Molecular weight: 300.74 Formula: C16H13ClN2O2 CLOGP: 2.34 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 52.90 ALOGS: -3.75 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

temazepam
(RS)-Temazepam
levanxene
levanxol

A benzodiazepine that acts as a GAMMA-AMINOBUTYRIC ACID modulator and anti-anxiety agent.

Molecular weight: 300.74
Formula: C16H13ClN2O2
CLOGP: 2.34
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 52.90
ALOGS: -3.75
ROTB: 1

Status: OFP

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

Drug dosage:

Dose	Unit	Route
20	mg	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	91 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.83 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
S (Water solubility)	0.60 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
Feb. 27, 1981	FDA	MALLINCKRODT INC

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
Completed suicide	451.90	10.06	583	52705	145090	63290644
Toxicity to various agents	399.57	10.06	731	52557	246519	63189215
Temperature regulation disorder	324.47	10.06	139	53149	5993	63429741
Coeliac disease	248.52	10.06	147	53141	12650	63423084
Food allergy	248.05	10.06	141	53147	11260	63424474
Overdose	232.36	10.06	376	52912	114702	63321032
Immunodeficiency	178.69	10.06	143	53145	20111	63415623
Hyperhidrosis	156.47	10.06	305	52983	107531	63328203
Pemphigus	139.60	10.06	3	53285	183723	63252011
Rash erythematous	126.59	10.06	167	53121	42343	63393391

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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	691.98	11.61	862	29814	199500	34726755
Completed suicide	346.18	11.61	428	30248	97740	34828515
Drug abuse	217.11	11.61	344	30332	98752	34827503
Poisoning	116.53	11.61	92	30584	12134	34914121
Overdose	113.24	11.61	248	30428	90811	34835444
Aggression	112.19	11.61	154	30522	38810	34887445
Dysarthria	102.44	11.61	139	30537	34643	34891612
Intrusive thoughts	101.59	11.61	28	30648	287	34925968
Off label use	84.25	11.61	150	30526	419374	34506881
Substance abuse	80.44	11.61	61	30615	7580	34918675

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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	991.48	10.19	1494	67216	420046	79255632
Completed suicide	822.37	10.19	1034	67676	244733	79430945
Temperature regulation disorder	317.24	10.19	136	68574	5717	79669961
Overdose	305.95	10.19	560	68150	183646	79492032
Drug abuse	264.30	10.19	490	68220	162201	79513477
Coeliac disease	250.50	10.19	143	68567	11208	79664470
Food allergy	232.55	10.19	134	68576	10690	79664988
Poisoning	179.03	10.19	159	68551	25113	79650565
Immunodeficiency	156.27	10.19	138	68572	21630	79654048
Substance abuse	130.27	10.19	92	68618	10434	79665244

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N05CD07	NERVOUS SYSTEM PSYCHOLEPTICS HYPNOTICS AND SEDATIVES Benzodiazepine derivatives
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
MeSH PA	D018757	GABA Modulators
MeSH PA	D006993	Hypnotics and Sedatives
MeSH PA	D018377	Neurotransmitter 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
Insomnia	indication	193462001
Suicidal thoughts	contraindication	6471006
Alcohol intoxication	contraindication	25702006
Depressive disorder	contraindication	35489007
Substance abuse	contraindication	66214007
Sleep apnea	contraindication	73430006	DOID:0050847
Kidney disease	contraindication	90708001	DOID:557
Hypoalbuminemia	contraindication	119247004
Disease of liver	contraindication	235856003	DOID:409
Sleep automatism	contraindication	247962006

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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	9.07	acidic
pKa2	1.46	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-2/gamma-2	Ion channel	P14867 P18507 P47870	GBRA1_HUMAN GBRG2_HUMAN GBRB2_HUMAN	POSITIVE ALLOSTERIC MODULATOR				WOMBAT-PK	CHEMBL
Nuclear receptor subfamily 1 group I member 3	Nuclear hormone receptor	Q14994	NR1I3_HUMAN					WOMBAT-PK

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External reference:

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ID	Source
001450	NDDF
10355	RXNORM
2322	MMSL
2753	INN_ID
387300007	SNOMEDCT_US
4017894	VUID
4017894	VANDF
5391	PUBCHEM_CID
54705000	SNOMEDCT_US
5544	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
RESTORIL	HUMAN PRESCRIPTION DRUG LABEL	1	0406-9914	CAPSULE	22.50 mg	ORAL	NDA	26 sections
RESTORIL	HUMAN PRESCRIPTION DRUG LABEL	1	0406-9914	CAPSULE	22.50 mg	ORAL	NDA	26 sections
RESTORIL	HUMAN PRESCRIPTION DRUG LABEL	1	0406-9915	CAPSULE	7.50 mg	ORAL	NDA	26 sections
RESTORIL	HUMAN PRESCRIPTION DRUG LABEL	1	0406-9915	CAPSULE	7.50 mg	ORAL	NDA	26 sections
RESTORIL	HUMAN PRESCRIPTION DRUG LABEL	1	0406-9916	CAPSULE	15 mg	ORAL	NDA	26 sections
RESTORIL	HUMAN PRESCRIPTION DRUG LABEL	1	0406-9916	CAPSULE	15 mg	ORAL	NDA	26 sections
RESTORIL	HUMAN PRESCRIPTION DRUG LABEL	1	0406-9917	CAPSULE	30 mg	ORAL	NDA	26 sections
RESTORIL	HUMAN PRESCRIPTION DRUG LABEL	1	0406-9917	CAPSULE	30 mg	ORAL	NDA	26 sections
Temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2076	CAPSULE	15 mg	ORAL	ANDA	19 sections
Temazepam	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2076	CAPSULE	15 mg	ORAL	ANDA	19 sections

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