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

Stem definition	Drug id	CAS RN
psychoactive	1816	85650-52-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: mirtazapine mepirzapin mepirzepine mirtabene mirtazepine mirtazipine	A piperazinoazepine tetracyclic compound that enhances the release of NOREPINEPHRINE and SEROTONIN through blockage of presynaptic ALPHA-2 ADRENERGIC RECEPTORS. It also blocks both 5-HT2 and 5-HT3 serotonin receptors and is a potent HISTAMINE H1 RECEPTOR antagonist. It is used for the treatment of depression, and may also be useful for the treatment of anxiety disorders. Molecular weight: 265.36 Formula: C17H19N3 CLOGP: 3.07 LIPINSKI: 0 HAC: 3 HDO: 0 TPSA: 19.37 ALOGS: -2.38 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

mirtazapine
mepirzapin
mepirzepine
mirtabene
mirtazepine
mirtazipine

A piperazinoazepine tetracyclic compound that enhances the release of NOREPINEPHRINE and SEROTONIN through blockage of presynaptic ALPHA-2 ADRENERGIC RECEPTORS. It also blocks both 5-HT2 and 5-HT3 serotonin receptors and is a potent HISTAMINE H1 RECEPTOR antagonist. It is used for the treatment of depression, and may also be useful for the treatment of anxiety disorders.

Molecular weight: 265.36
Formula: C17H19N3
CLOGP: 3.07
LIPINSKI: 0
HAC: 3
HDO: 0
TPSA: 19.37
ALOGS: -2.38
ROTB: 0

Status: OFP

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

Drug dosage:

Dose	Unit	Route
30	mg	O

ADMET properties:

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Property	Value	Reference
CL (Clearance)	8 mL/min/kg	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	4.20 L/kg	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	2.83 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
EoM (Fraction excreted unchanged in urine)	2 %	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	15 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.50 mg/mL	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.15 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
June 14, 1996	FDA	ORGANON USA 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
Intentional overdose	851.89	10.10	840	111678	73312	63303192
Serotonin syndrome	647.13	10.10	479	112039	28203	63348301
Toxicity to various agents	630.32	10.10	1367	111151	245883	63130621
Suicide attempt	569.35	10.10	618	111900	60300	63316204
Intentional self-injury	566.08	10.10	423	112095	25264	63351240
Drug abuse	509.10	10.10	635	111883	71883	63304621
Completed suicide	490.20	10.10	905	111613	144768	63231736
Sopor	479.50	10.10	361	112157	21803	63354701
Drug interaction	440.06	10.10	1135	111383	227996	63148508
Suicidal ideation	427.57	10.10	540	111978	61881	63314623

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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	589.64	10.79	1346	76670	199016	34679899
Intentional overdose	500.49	10.79	550	77466	43124	34835791
Intentional self-injury	419.30	10.79	302	77714	13469	34865446
Completed suicide	380.32	10.79	739	77277	97429	34781486
Suicide attempt	358.15	10.79	439	77577	38677	34840238
Suicidal ideation	301.87	10.79	410	77606	39978	34838937
Serotonin syndrome	298.54	10.79	290	77726	19643	34859272
Agitation	277.67	10.79	476	77540	56923	34821992
Drug abuse	254.91	10.79	633	77383	98463	34780452
Overdose	254.90	10.79	601	77415	90458	34788457

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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	1149.79	9.84	2610	160749	418930	79162099
Intentional overdose	942.32	9.84	1123	162236	104837	79476192
Serotonin syndrome	844.73	9.84	716	162643	44311	79536718
Completed suicide	782.90	9.84	1622	161737	244145	79336884
Suicide attempt	763.71	9.84	895	162464	82037	79498992
Intentional self-injury	698.98	9.84	559	162800	31860	79549169
Drug abuse	680.64	9.84	1206	162153	161485	79419544
Suicidal ideation	655.32	9.84	795	162564	75545	79505484
Sopor	598.81	9.84	515	162844	32495	79548534
Overdose	528.69	9.84	1166	162193	183040	79397989

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FDA Adverse Event Reporting System (Pediatric)

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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
Neonatal seizure	36.23	30.88	28	595	437	88732

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Pharmacologic Action:

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Source	Code	Description
ATC	N06AX11	NERVOUS SYSTEM PSYCHOANALEPTICS ANTIDEPRESSANTS Other antidepressants
CHEBI has role	CHEBI:35474	anti-anxiety agents
CHEBI has role	CHEBI:37890	alpha-adrenergic receptor blockaders
CHEBI has role	CHEBI:37955	H1 receptor antagonists
CHEBI has role	CHEBI:37956	antihistamines
CHEBI has role	CHEBI:48279	serotonin antagonists
CHEBI has role	CHEBI:146270	oneirogens
MeSH PA	D018663	Adrenergic Agents
MeSH PA	D058669	Adrenergic alpha-2 Receptor Antagonists
MeSH PA	D000317	Adrenergic alpha-Antagonists

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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
Major depressive disorder	indication	370143000
Excessive vomiting in pregnancy	off-label use	14094001
Posttraumatic stress disorder	off-label use	47505003	DOID:2055
Suicidal thoughts	contraindication	6471006
Weight gain finding	contraindication	8943002
Hypercholesterolemia	contraindication	13644009
Myocardial infarction	contraindication	22298006	DOID:5844
Hypovolemia	contraindication	28560003
Orthostatic hypotension	contraindication	28651003
Dehydration	contraindication	34095006

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🐶 Veterinary Drug Use

Species	Use	Relation
Cats	Management of weight loss in cats	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Mirataz	Dechra, Ltd.	1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.67	Basic
pKa2	2.91	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])	Bioact source	MoA source
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN	ANTAGONIST	Ki	7.41	CHEMBL	CHEMBL
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN	ANTAGONIST	Ki	7.16	CHEMBL	CHEMBL
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN	ANTAGONIST	Ki	7.70	CHEMBL
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Ki	5.34	PDSP
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN		Kd	5.30	CHEMBL
5-hydroxytryptamine receptor 7	GPCR	P34969	5HT7R_HUMAN		Ki	6.58	CHEMBL
Alpha-1A adrenergic receptor	GPCR	P35348	ADA1A_HUMAN		IC50	5.50	CHEMBL
Alpha-2B adrenergic receptor	GPCR	P18089	ADA2B_HUMAN	ANTAGONIST	IC50	6.65	CHEMBL
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	5.24	CHEMBL
Histamine H1 receptor	GPCR	P35367	HRH1_HUMAN		Ki	8.80	WOMBAT-PK

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External reference:

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ID	Source
006054	NDDF
108430001	SNOMEDCT_US
15996	RXNORM
386847004	SNOMEDCT_US
4020978	VUID
4020978	VANDF
4205	PUBCHEM_CID
46110	MMSL
5120	MMSL
6481	INN_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3515	TABLET, FILM COATED	15 mg	ORAL	ANDA	29 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3515	TABLET, FILM COATED	15 mg	ORAL	ANDA	29 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3530	TABLET, FILM COATED	30 mg	ORAL	ANDA	29 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3530	TABLET, FILM COATED	30 mg	ORAL	ANDA	29 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3545	TABLET, FILM COATED	45 mg	ORAL	ANDA	29 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3545	TABLET, FILM COATED	45 mg	ORAL	ANDA	29 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8078	TABLET	7.50 mg	ORAL	ANDA	25 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8078	TABLET	7.50 mg	ORAL	ANDA	25 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8268	TABLET, FILM COATED	15 mg	ORAL	ANDA	25 sections
Mirtazapine	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8269	TABLET, FILM COATED	30 mg	ORAL	ANDA	25 sections

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