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

Stem definition	Drug id	CAS RN
anorexics	841	51-64-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: dextroamphetamine S-Amphetamine D-Amphetamine dexadrine dexamfetamine dextroamphetamine sulfate dextroamphetamine saccharate dextroamphetamine adipate dextroamphetamine resin complex	The d-form of AMPHETAMINE. It is a central nervous system stimulant and a sympathomimetic. It has also been used in the treatment of narcolepsy and of attention deficit disorders and hyperactivity in children. Dextroamphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulating release of monamines, and inhibiting monoamine oxidase. It is also a drug of abuse and a psychotomimetic. Molecular weight: 135.21 Formula: C9H13N CLOGP: 1.74 LIPINSKI: 0 HAC: 1 HDO: 1 TPSA: 26.02 ALOGS: -1.89 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

dextroamphetamine
S-Amphetamine
D-Amphetamine
dexadrine
dexamfetamine
dextroamphetamine sulfate
dextroamphetamine saccharate
dextroamphetamine adipate
dextroamphetamine resin complex

The d-form of AMPHETAMINE. It is a central nervous system stimulant and a sympathomimetic. It has also been used in the treatment of narcolepsy and of attention deficit disorders and hyperactivity in children. Dextroamphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulating release of monamines, and inhibiting monoamine oxidase. It is also a drug of abuse and a psychotomimetic.

Molecular weight: 135.21
Formula: C9H13N
CLOGP: 1.74
LIPINSKI: 0
HAC: 1
HDO: 1
TPSA: 26.02
ALOGS: -1.89
ROTB: 2

Status: OFP

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

Drug dosage:

Dose	Unit	Route
15	mg	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	75 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
MRTD (Maximum Recommended Therapeutic Daily Dose)	7.40 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
EoM (Fraction excreted unchanged in urine)	40 %	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	1 mg/mL	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	0	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
Sept. 9, 1955	FDA	UCB 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
Anxiety	79.28	15.41	116	7881	217425	63263600
Coronary artery dissection	69.04	15.41	17	7980	845	63480180
Migraine	66.11	15.41	73	7924	103273	63377752
Pre-existing condition improved	62.05	15.41	27	7970	8217	63472808
Depression	60.57	15.41	97	7900	196395	63284630
Suicidal ideation	48.63	15.41	49	7948	62372	63418653
Feeling abnormal	45.33	15.41	73	7924	148319	63332706
Cataplexy	44.48	15.41	13	7984	1243	63479782
Suspected product quality issue	37.18	15.41	8	7989	217	63480808
Product substitution issue	35.05	15.41	23	7974	15973	63465052

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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
Oppositional defiant disorder	112.27	24.37	23	4087	526	34952295
Decreased eye contact	108.69	24.37	22	4088	473	34952348
Aggression	94.16	24.37	58	4052	38906	34913915
Bruxism	90.70	24.37	24	4086	1711	34951110
Product substitution issue	81.39	24.37	34	4076	10061	34942760
Coordination abnormal	79.77	24.37	31	4079	7613	34945208
Crying	76.50	24.37	28	4082	5834	34946987
Homicidal ideation	76.04	24.37	23	4087	2659	34950162
Suicidal ideation	75.08	24.37	51	4059	40337	34912484
Anxiety	65.59	24.37	69	4041	99359	34853462

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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
Oppositional defiant disorder	115.96	17.22	23	8782	474	79735109
Decreased eye contact	97.79	17.22	22	8783	843	79734740
Anxiety	92.53	17.22	125	8680	248387	79487196
Product substitution issue	83.50	17.22	42	8763	20214	79715369
Aggression	80.76	17.22	57	8748	50901	79684682
Bruxism	80.27	17.22	26	8779	4000	79731583
Homicidal ideation	75.80	17.22	24	8781	3433	79732150
Coronary artery dissection	71.41	17.22	18	8787	1126	79734457
Suicidal ideation	70.31	17.22	62	8743	76278	79659305
Depression	70.14	17.22	102	8703	216688	79518895

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N06BA02	NERVOUS SYSTEM PSYCHOANALEPTICS PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS Centrally acting sympathomimetics
CHEBI has role	CHEBI:35524	sympathomimetic
CHEBI has role	CHEBI:35640	adrenergic uptake inhibitors
CHEBI has role	CHEBI:37962	adrenergic agents
CHEBI has role	CHEBI:48560	dopaminergic agents
CHEBI has role	CHEBI:50910	agente neurotoxico
CHEBI has role	CHEBI:51039	dopamine reuptake inhibitor
FDA EPC	N0000175739	Central Nervous System Stimulant
FDA PE	N0000175729	Central Nervous System Stimulation
MeSH PA	D002491	Central Nervous System 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
Narcolepsy	indication	60380001	DOID:8986
Attention deficit hyperactivity disorder	indication	406506008
Gilles de la Tourette's syndrome	contraindication	5158005	DOID:11119
Dependent drug abuse	contraindication	6525002
Bipolar disorder	contraindication	13746004	DOID:3312
Myocardial infarction	contraindication	22298006	DOID:5844
Glaucoma	contraindication	23986001	DOID:1686
Feeling agitated	contraindication	24199005
Hyperthyroidism	contraindication	34486009	DOID:7998
Hypertensive disorder	contraindication	38341003	DOID:10763

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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	9.89	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
12.5MG;12.5MG;12.5MG;12.5MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	6913768	May 24, 2023	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
12.5MG;12.5MG;12.5MG;12.5MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	9173857	May 12, 2026	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
13.5MG/9HR	XELSTRYM	NOVEN PHARMS INC	N215401	March 22, 2022	RX	SYSTEM	TRANSDERMAL	9456993	Oct. 24, 2033	A METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER BY ADMINISTERING A TRANSDERMAL COMPOSITION CONTAINING AMPHETAMINE
18MG/9HR	XELSTRYM	NOVEN PHARMS INC	N215401	March 22, 2022	RX	SYSTEM	TRANSDERMAL	9456993	Oct. 24, 2033	A METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER BY ADMINISTERING A TRANSDERMAL COMPOSITION CONTAINING AMPHETAMINE
3.125MG;3.125MG;3.125MG;3.125MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	6913768	May 24, 2023	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
3.125MG;3.125MG;3.125MG;3.125MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	9173857	May 12, 2026	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
4.5MG/9HR	XELSTRYM	NOVEN PHARMS INC	N215401	March 22, 2022	RX	SYSTEM	TRANSDERMAL	9456993	Oct. 24, 2033	A METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER BY ADMINISTERING A TRANSDERMAL COMPOSITION CONTAINING AMPHETAMINE
6.25MG;6.25MG;6.25MG;6.25MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	6913768	May 24, 2023	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
6.25MG;6.25MG;6.25MG;6.25MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	9173857	May 12, 2026	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
9.375MG;9.375MG;9.375MG;9.375MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	6913768	May 24, 2023	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER

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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
12.5MG;12.5MG;12.5MG;12.5MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	March 13, 2023	PEDIATRIC EXCLUSIVITY
13.5MG/9HR	XELSTRYM	NOVEN PHARMS INC	N215401	March 22, 2022	RX	SYSTEM	TRANSDERMAL	March 22, 2025	NEW PRODUCT
18MG/9HR	XELSTRYM	NOVEN PHARMS INC	N215401	March 22, 2022	RX	SYSTEM	TRANSDERMAL	March 22, 2025	NEW PRODUCT
3.125MG;3.125MG;3.125MG;3.125MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	March 13, 2023	PEDIATRIC EXCLUSIVITY
4.5MG/9HR	XELSTRYM	NOVEN PHARMS INC	N215401	March 22, 2022	RX	SYSTEM	TRANSDERMAL	March 22, 2025	NEW PRODUCT
6.25MG;6.25MG;6.25MG;6.25MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	March 13, 2023	PEDIATRIC EXCLUSIVITY
9.375MG;9.375MG;9.375MG;9.375MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	March 13, 2023	PEDIATRIC EXCLUSIVITY
9MG/9HR	XELSTRYM	NOVEN PHARMS INC	N215401	March 22, 2022	RX	SYSTEM	TRANSDERMAL	March 22, 2025	NEW PRODUCT

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Synaptic vesicular amine transporter	Transporter	Q05940	VMAT2_HUMAN	INHIBITOR			CHEMBL	CHEMBL
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN	INHIBITOR	Ki	7	IUPHAR	CHEMBL
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN	RELEASING AGENT	Ki	6.68	WOMBAT-PK	CHEMBL
Alpha-1A adrenergic receptor	GPCR	P35348	ADA1A_HUMAN				WOMBAT-PK
Cocaine- and amphetamine-regulated transcript protein	Transcription factor	Q16568	CART_HUMAN				WOMBAT-PK
Amine oxidase [flavin-containing] A	Enzyme	P21397	AOFA_HUMAN		Ki	4.84	CHEMBL
Trace amine-associated receptor 1	GPCR	Q96RJ0	TAAR1_HUMAN		EC50	6.87	WOMBAT-PK
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN				WOMBAT-PK
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN		Ki	5.24	CHEMBL
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN		Ki	5.18	PDSP

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External reference:

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ID	Source
1WE	PDB_CHEM_ID
001793	NDDF
001795	NDDF
006720	NDDF
1430	INN_ID
1604	MMSL
2147	IUPHAR_LIGAND_ID
221088	RXNORM
350708-40-6	SECONDARY_CAS_RN
387022005	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1486	CAPSULE	1.25 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1486	CAPSULE	1.25 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1486	CAPSULE	1.25 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1486	CAPSULE	1.25 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1487	CAPSULE	2.50 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1487	CAPSULE	2.50 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1487	CAPSULE	2.50 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1487	CAPSULE	2.50 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1488	CAPSULE	3.75 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1488	CAPSULE	3.75 mg	ORAL	ANDA	28 sections

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