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

Stem definition	Drug id	CAS RN
dopamine receptor agonists, dopamine derivatives, used as antiparkinsonism/prolactin inhibitors	971	23651-95-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: northera L-DOPS droxidopa threo-Dopaserine L-threo-3,4-Dihydroxyphenylserine	A synthetic precursor of norepinephrine that is used in the treatment of PARKINSONIAN DISORDERS and ORTHOSTATIC HYPOTENSION. Molecular weight: 213.19 Formula: C9H11NO5 CLOGP: -2.48 LIPINSKI: 0 HAC: 6 HDO: 5 TPSA: 124.01 ALOGS: -1.14 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

northera
L-DOPS
droxidopa
threo-Dopaserine
L-threo-3,4-Dihydroxyphenylserine

A synthetic precursor of norepinephrine that is used in the treatment of PARKINSONIAN DISORDERS and ORTHOSTATIC HYPOTENSION.

Molecular weight: 213.19
Formula: C9H11NO5
CLOGP: -2.48
LIPINSKI: 0
HAC: 6
HDO: 5
TPSA: 124.01
ALOGS: -1.14
ROTB: 3

Status: OFP

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

Drug dosage:

Dose	Unit	Route
1	g	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	90 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility)	15.30 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
Feb. 18, 2014	FDA	LUNDBECK NA LTD

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
Dizziness	748.57	32.19	611	10674	429314	63048423
Blood pressure increased	473.37	32.19	316	10969	161746	63315991
Product dose omission issue	406.83	32.19	334	10951	233979	63243758
Blood pressure decreased	327.03	32.19	180	11105	64842	63412895
Loss of consciousness	303.16	32.19	213	11072	117908	63359829
Blood pressure fluctuation	271.40	32.19	142	11143	46175	63431562
Headache	244.52	32.19	416	10869	632825	62844912
Death	220.76	32.19	300	10985	374081	63103656
Fall	205.41	32.19	297	10988	392037	63085700
Supine hypertension	204.56	32.19	30	11255	38	63477699

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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
Dizziness	780.48	31.63	617	11174	217904	34727236
Death	737.64	31.63	776	11015	397273	34547867
Blood pressure increased	600.30	31.63	371	11420	87731	34857409
Fall	455.08	31.63	441	11350	202444	34742696
Blood pressure fluctuation	406.76	31.63	189	11602	25060	34920080
Product dose omission issue	396.65	31.63	325	11466	119386	34825754
Blood pressure decreased	349.96	31.63	217	11574	51298	34893842
Loss of consciousness	247.38	31.63	212	11579	82455	34862685
Hypertension	239.94	31.63	261	11530	136182	34808958
Drug ineffective	192.41	31.63	452	11339	456299	34488841

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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
Death	1034.36	29.10	880	15513	565634	79162361
Dizziness	878.84	29.10	778	15615	525663	79202332
Blood pressure increased	808.69	29.10	515	15878	210845	79517150
Product dose omission issue	644.72	29.10	476	15917	247061	79480934
Blood pressure decreased	491.12	29.10	286	16107	99180	79628815
Fall	480.73	29.10	543	15850	487086	79240909
Blood pressure fluctuation	449.31	29.10	236	16157	66909	79661086
Loss of consciousness	420.61	29.10	316	16077	167627	79560368
Supine hypertension	280.51	29.10	52	16341	372	79727623
Hypotension	245.30	29.10	371	16022	439946	79288049

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	C01CA27	CARDIOVASCULAR SYSTEM CARDIAC THERAPY CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES Adrenergic and dopaminergic agents
CHEBI has role	CHEBI:25512	neurotransmitters
CHEBI has role	CHEBI:35524	sympathomimetic
CHEBI has role	CHEBI:35569	alpha-adrenergic agonists
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:35674	antihypertensive drugs
CHEBI has role	CHEBI:50266	Prodrugs
FDA CS	M0003647	Catecholamines
FDA EPC	N0000175570	Catecholamine
FDA PE	N0000178478	Increased Blood Pressure

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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
Orthostatic hypotension	indication	28651003
Parkinson's disease	indication	49049000	DOID:14330

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🐶 Veterinary Drug Use

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🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.23	acidic
pKa2	9.52	acidic
pKa3	11.41	acidic
pKa4	12.37	acidic
pKa5	8.22	Basic

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Orange Book patent data (new drug applications)

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Orange Book exclusivity data (new drug applications)

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Adrenergic receptor	GPCR	P07550 P08588 P08913 P13945 P18089 P18825 P25100 P35348 P35368	ADRB2_HUMAN ADRB1_HUMAN ADA2A_HUMAN ADRB3_HUMAN ADA2B_HUMAN ADA2C_HUMAN ADA1D_HUMAN ADA1A_HUMAN ADA1B_HUMAN	AGONIST				CHEMBL	CHEMBL
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN	ANTAGONIST	Ki	7.10		IUPHAR

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External reference:

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ID	Source
LT4	PDB_CHEM_ID
004718	NDDF
008194	NDDF
111130009	SNOMEDCT_US
1489913	RXNORM
213092	MMSL
27016	MMSL
2706	MMSL
33	INN_ID
343658	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Droxidopa	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0532	CAPSULE	100 mg	ORAL	ANDA	27 sections
Droxidopa	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0533	CAPSULE	200 mg	ORAL	ANDA	27 sections
Droxidopa	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0534	CAPSULE	300 mg	ORAL	ANDA	27 sections
Droxidopa	HUMAN PRESCRIPTION DRUG LABEL	1	0832-0720	CAPSULE	100 mg	ORAL	ANDA	29 sections
Droxidopa	HUMAN PRESCRIPTION DRUG LABEL	1	0832-0720	CAPSULE	100 mg	ORAL	ANDA	29 sections
Droxidopa	HUMAN PRESCRIPTION DRUG LABEL	1	0832-0721	CAPSULE	200 mg	ORAL	ANDA	29 sections
Droxidopa	HUMAN PRESCRIPTION DRUG LABEL	1	0832-0721	CAPSULE	200 mg	ORAL	ANDA	29 sections
Droxidopa	HUMAN PRESCRIPTION DRUG LABEL	1	0832-0722	CAPSULE	300 mg	ORAL	ANDA	29 sections
Droxidopa	HUMAN PRESCRIPTION DRUG LABEL	1	0832-0722	CAPSULE	300 mg	ORAL	ANDA	29 sections
Droxidopa	Human Prescription Drug Label	1	27241-199	CAPSULE	100 mg	ORAL	ANDA	27 sections

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