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

Stem definition	Drug id	CAS RN
	835	113775-47-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: dexmedetomidine (S)-Medetomidine dexmedetomidine hydrochloride dexdor dexmedetomidine HCl MPV1440 precedex	A imidazole derivative that is an agonist of ADRENERGIC ALPHA-2 RECEPTORS. It is closely-related to MEDETOMIDINE, which is the racemic form of this compound. Molecular weight: 200.29 Formula: C13H16N2 CLOGP: 3.10 LIPINSKI: 0 HAC: 2 HDO: 1 TPSA: 28.68 ALOGS: -3.06 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

dexmedetomidine
(S)-Medetomidine
dexmedetomidine hydrochloride
dexdor
dexmedetomidine HCl
MPV1440
precedex

A imidazole derivative that is an agonist of ADRENERGIC ALPHA-2 RECEPTORS. It is closely-related to MEDETOMIDINE, which is the racemic form of this compound.

Molecular weight: 200.29
Formula: C13H16N2
CLOGP: 3.10
LIPINSKI: 0
HAC: 2
HDO: 1
TPSA: 28.68
ALOGS: -3.06
ROTB: 2

Status: OFP

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

Drug dosage:

Dose	Unit	Route
1	mg	P

ADMET properties:

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Property	Value	Reference
S (Water solubility)	20 mg/mL	Bocci G, Oprea TI, Benet LZ
t_half (Half-life)	2.20 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	11 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	1.60 L/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.09 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
fu (Fraction unbound in plasma)	0.06 %	Lombardo F, Berellini G, Obach RS

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Approvals:

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Date	Agency	Company
Dec. 17, 1999	FDA	HOSPIRA
Jan. 29, 2001	PMDA	Abbott Japan, Maruishi Pharmaceutical
Sept. 15, 2011	EMA	Orion Corporation

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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
Bradycardia	236.92	30.29	108	3953	73119	63411842
Product administered to patient of inappropriate age	119.31	30.29	30	4031	3238	63481723
Hypotension	87.69	30.29	97	3964	272507	63212454
Delirium	82.28	30.29	47	4014	50494	63434467
Agitation	80.07	30.29	49	4012	59708	63425253
Upper airway obstruction	78.07	30.29	16	4045	687	63484274
Floppy iris syndrome	76.08	30.29	12	4049	110	63484851
Respiratory depression	73.42	30.29	29	4032	13686	63471275
Glossoptosis	73.15	30.29	11	4050	71	63484890
Cardiac arrest	71.59	30.29	54	4007	92491	63392470

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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
Bradycardia	371.60	24.32	207	6148	75211	34875365
Diabetes insipidus	267.56	24.32	69	6286	2859	34947717
Cardiac arrest	208.88	24.32	158	6197	96001	34854575
Hyperthermia	148.62	24.32	60	6295	10517	34940059
Intestinal pseudo-obstruction	144.05	24.32	38	6317	1718	34948858
Product administered to patient of inappropriate age	133.04	24.32	41	6314	3250	34947326
Arteriospasm coronary	115.32	24.32	37	6318	3345	34947231
Hyperthermia malignant	109.04	24.32	32	6323	2145	34948431
Drug withdrawal syndrome	101.42	24.32	56	6299	19778	34930798
Delirium	98.99	24.32	74	6281	43917	34906659

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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
Bradycardia	472.77	25.06	260	9594	135297	79599237
Diabetes insipidus	272.89	25.06	73	9781	5164	79729370
Cardiac arrest	264.39	25.06	197	9657	171899	79562635
Product administered to patient of inappropriate age	204.65	25.06	59	9795	5494	79729040
Hyperthermia	187.68	25.06	74	9780	17963	79716571
Intestinal pseudo-obstruction	143.64	25.06	38	9816	2571	79731963
Delirium	138.92	25.06	101	9753	84526	79650008
Hypotension	137.56	25.06	216	9638	440101	79294433
Drug withdrawal syndrome	121.63	25.06	67	9787	34651	79699883
Arteriospasm coronary	112.06	25.06	39	9815	6677	79727857

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N05CM18	NERVOUS SYSTEM PSYCHOLEPTICS HYPNOTICS AND SEDATIVES Other hypnotics and sedatives
CHEBI has role	CHEBI:35569	alpha-adrenergic agonists
CHEBI has role	CHEBI:35717	hypnotics
FDA EPC	N0000175554	Central alpha-2 Adrenergic Agonist
FDA MoA	N0000009918	Adrenergic alpha2-Agonists
FDA PE	N0000175975	General Anesthesia
MeSH PA	D018663	Adrenergic Agents
MeSH PA	D000322	Adrenergic Agonists
MeSH PA	D058647	Adrenergic alpha-2 Receptor Agonists
MeSH PA	D000316	Adrenergic alpha-Agonists

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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
Conscious sedation	indication	314271007
Complete atrioventricular block	contraindication	27885002
Hypovolemia	contraindication	28560003
Hypertensive disorder	contraindication	38341003	DOID:10763
Low blood pressure	contraindication	45007003
Chronic heart failure	contraindication	48447003
Bradycardia	contraindication	48867003
Diabetes mellitus	contraindication	73211009	DOID:9351
Kidney disease	contraindication	90708001	DOID:557
Disease of liver	contraindication	235856003	DOID:409

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🐶 Veterinary Drug Use

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Species	Use	Relation
Cats	Preanesthesia to general anesthesia	Indication
Cats	Sedation and analgesia	Indication
Dogs	Preanesthesia to general anesthesia	Indication
Dogs	Sedation and analgesia	Indication
Dogs	Noise aversion	Indication

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🐶 Veterinary products

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Product	Applicant	Ingredients
Dexdomitor	Orion Corp.	1
Dexmedesed	Dechra Veterinary Products LLC	1
Dexmedetomidine Hydrochloride Injection	Akorn Animal Health Inc.	1
SILEO	Orion Corp.	1

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Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.36	acidic
pKa2	6.76	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 0.12MG BASE	IGALMI	BIOXCEL	N215390	April 5, 2022	RX	FILM	BUCCAL, SUBLINGUAL	10792246	June 26, 2039	ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL ADMINISTRATION
EQ 0.12MG BASE	IGALMI	BIOXCEL	N215390	April 5, 2022	RX	FILM	BUCCAL, SUBLINGUAL	11497711	June 26, 2039	ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION
EQ 0.12MG BASE	IGALMI	BIOXCEL	N215390	April 5, 2022	RX	FILM	BUCCAL, SUBLINGUAL	11517524	June 26, 2039	ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION
EQ 0.18MG BASE	IGALMI	BIOXCEL	N215390	April 5, 2022	RX	FILM	BUCCAL, SUBLINGUAL	10792246	June 26, 2039	ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL ADMINISTRATION
EQ 0.18MG BASE	IGALMI	BIOXCEL	N215390	April 5, 2022	RX	FILM	BUCCAL, SUBLINGUAL	11497711	June 26, 2039	ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION
EQ 0.18MG BASE	IGALMI	BIOXCEL	N215390	April 5, 2022	RX	FILM	BUCCAL, SUBLINGUAL	11517524	June 26, 2039	ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	PRECEDEX	HOSPIRA	N021038	March 13, 2013	RX	INJECTABLE	INJECTION	8455527	Jan. 4, 2032	USE FOR SEDATION
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	PRECEDEX	HOSPIRA	N021038	March 13, 2013	RX	INJECTABLE	INJECTION	8455527	Jan. 4, 2032	USE FOR SEDATION
EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	PRECEDEX	HOSPIRA	N021038	Nov. 14, 2014	RX	INJECTABLE	INJECTION	8455527	Jan. 4, 2032	USE FOR SEDATION

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 0.12MG BASE	IGALMI	BIOXCEL	N215390	April 5, 2022	RX	FILM	BUCCAL, SUBLINGUAL	April 5, 2025	NEW PRODUCT
EQ 0.18MG BASE	IGALMI	BIOXCEL	N215390	April 5, 2022	RX	FILM	BUCCAL, SUBLINGUAL	April 5, 2025	NEW PRODUCT
EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)	PRECEDEX	HOSPIRA	N021038	Jan. 31, 2020	RX	INJECTABLE	INJECTION	Dec. 16, 2025	NEW PATIENT POPULATION
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	PRECEDEX	HOSPIRA	N021038	Dec. 17, 1999	RX	INJECTABLE	INJECTION	Dec. 16, 2025	NEW PATIENT POPULATION
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	PRECEDEX	HOSPIRA	N021038	March 13, 2013	RX	INJECTABLE	INJECTION	Dec. 16, 2025	NEW PATIENT POPULATION
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	PRECEDEX	HOSPIRA	N021038	March 13, 2013	RX	INJECTABLE	INJECTION	Dec. 16, 2025	NEW PATIENT POPULATION
EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	PRECEDEX	HOSPIRA	N021038	Nov. 14, 2014	RX	INJECTABLE	INJECTION	Dec. 16, 2025	NEW PATIENT POPULATION

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Alpha-2B adrenergic receptor	GPCR	P18089	ADA2B_HUMAN	AGONIST	Ki	9.70	IUPHAR	CHEMBL
Alpha-2C adrenergic receptor	GPCR	P18825	ADA2C_HUMAN	AGONIST	Ki	9.30	IUPHAR	CHEMBL
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN	AGONIST	EC50	8.82	CHEMBL	CHEMBL
Alpha-1B adrenergic receptor	GPCR	P35368	ADA1B_HUMAN		Ki	6.50	PDSP
Alpha-1A adrenergic receptor	GPCR	P35348	ADA1A_HUMAN		Ki	6.70	PDSP
Alpha-1D adrenergic receptor	GPCR	P25100	ADA1D_HUMAN		Ki	10.82	CHEMBL
Alpha-2A adrenergic receptor	GPCR		ADA2A_RAT		Ki	10.82	CHEMBL
Alpha-1A adrenergic receptor	GPCR		ADA1A_BOVIN		EC50	6.42	CHEMBL
Adrenergic receptor alpha-2	GPCR		ADA2B_RAT ADA2C_RAT ADA2A_RAT		Ki	10.82	CHEMBL
Adrenergic receptor alpha-1	GPCR		ADA1B_RAT ADA1D_RAT ADA1A_RAT		Ki	8.30	CHEMBL

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External reference:

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ID	Source
008084	NDDF
008085	NDDF
116348007	SNOMEDCT_US
145108-58-3	SECONDARY_CAS_RN
227894	MMSL
228054	RXNORM
29394	MMSL
31641	MMSL
4021214	VUID
4021214	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Dexmedetomidine HCl	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9532	INJECTION	100 ug	INTRAVENOUS	ANDA	30 sections
Dexmedetomidine HCl	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9532	INJECTION	100 ug	INTRAVENOUS	ANDA	30 sections
Dexmedetomidine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9525	INJECTION, SOLUTION	4 ug	INTRAVENOUS	ANDA	31 sections
Dexmedetomidine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9525	INJECTION, SOLUTION	4 ug	INTRAVENOUS	ANDA	31 sections
Dexmedetomidine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9526	INJECTION, SOLUTION	4 ug	INTRAVENOUS	ANDA	31 sections
Dexmedetomidine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9526	INJECTION, SOLUTION	4 ug	INTRAVENOUS	ANDA	31 sections
DEXMEDETOMIDINE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0338-9555	INJECTION	200 ug	INTRAVENOUS	ANDA	32 sections
DEXMEDETOMIDINE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0338-9555	INJECTION	200 ug	INTRAVENOUS	ANDA	32 sections
DEXMEDETOMIDINE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0338-9555	INJECTION	200 ug	INTRAVENOUS	ANDA	32 sections
DEXMEDETOMIDINE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0338-9557	INJECTION	400 ug	INTRAVENOUS	ANDA	32 sections

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