U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ABSOLUTE
Molecular Formula C15H25N3O.2CH4O3S
Molecular Weight 455.59
Optical Activity UNSPECIFIED
Defined Stereocenters 2 / 2
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of LISDEXAMFETAMINE DIMESYLATE

SMILES

CS(O)(=O)=O.CS(O)(=O)=O.C[C@@H](CC1=CC=CC=C1)NC(=O)[C@@H](N)CCCCN

InChI

InChIKey=CETWSOHVEGTIBR-FORAGAHYSA-N
InChI=1S/C15H25N3O.2CH4O3S/c1-12(11-13-7-3-2-4-8-13)18-15(19)14(17)9-5-6-10-16;2*1-5(2,3)4/h2-4,7-8,12,14H,5-6,9-11,16-17H2,1H3,(H,18,19);2*1H3,(H,2,3,4)/t12-,14-;;/m0../s1

HIDE SMILES / InChI

Description
Curator's Comment: description was created based on several sources, including https://blackpoppymag.wordpress.com/substances/dexedrine-dexamphetamine/

Amphetamine is also prescribed in enantiopure and prodrug form as dextroamphetamine and lisdexamfetamine respectively. Lisdexamfetamine is structurally different from amphetamine, and is inactive until it metabolizes into dextroamphetamine. Dextroamphetamine is useful for those with ADHD and Narcolepsy. It improves self-control for people who have a hard time naturally controlling themselves. Dextroamphetamine aids a person learning and memory of words, and perhaps makes the brain stronger. When a person given dextroamphetamine is tested, their brain is extremely active in the brain parts required for the test and radically less active in other parts. Short practice sessions with dextroamphetamine have a greater effect on learning than sessions without dextroamphetamine. Dextroamphetamine raises decision-making scores, improves choices, and changes beliefs about rewards; at the same time, dextroamphetamine barely—if at all—affects guesses of time. Those who feel lower amounts of joy from dextroamphetamine have greater impulsivity improvements compared to those who feel extreme happiness. The drug should be avoided for those who have hypersensitivity to amphetamines, a history of drug abuse, cardiovascular diseases, hypertensive disease, hyperthyroidism, or in those with glaucoma. In 1935, the medical community became aware of the stimulant properties of amphetamine, specifically dextroamphetamine, and in 1937 Smith, Kline, and French introduced Dexedrine tablets, under the tradename Dexedrine. In the United States, Dexedrine tablets were approved to treat narcolepsy, attention disorders, depression, and obesity. Dexedrine, along with other sympathomimetic, was eventually classified as schedule II, the most restrictive category possible for a drug with recognized medical uses. The exact mechanism of action is not known. Dextroamphetamine stimulates the release of norepinephrine from central adrenergic receptors. At higher dosages, it causes release of dopamine from the mesocorticolimbic system and the nigrostriatal dopamine systems by reversal of the monoamine transporters. Dextroamphetamine may also act as a direct agonist on central 5-HT receptors and may inhibit monoamine oxidase (MAO). Modulation of serotonergic pathways may contribute to the calming effect.

CNS Activity

Originator

Smith Kline & French Laboratories
33
Curator's Comment: in 1935, the medical community became aware of the stimulant properties of amphetamine, specifically dextroamphetamine, and in 1937 Smith, Kline, and French introduced Dexedrine tablets, under the tradename Dexedrine.

Approval Year

1937
60
Targets

Targets

Primary TargetPharmacologyConditionPotency
Modulator
828
Modulator
828
Inhibitor
8297
Modulator
828
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Approved
8429
VYVANSE

Approved Use

VYVANSE® is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14.1)

Launch Date

2007
Primary
Approved
8429
VYVANSE

Approved Use

VYVANSE® is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14.1)

Launch Date

2007
Primary
Approved
8429
DEXEDRINE

Approved Use

Narcolepsy. Attention Deficit Disorder with Hyperactivity. As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go”; excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

Launch Date

1980
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
47.9 ng/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/18021493/
70 mg 1 times / day multiple, oral
dose: 70 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
LISDEXAMFETAMINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
24.7 ng/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/9807980/
10 mg single, oral
dose: 10 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
DEXTROAMPHETAMINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
36.6 ng/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040361Orig1s017lbl.pdf
15 mg single, oral
dose: 15 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
DEXTROAMPHETAMINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
60.7 ng × h/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/18021493/
70 mg 1 times / day multiple, oral
dose: 70 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
LISDEXAMFETAMINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
431 ng × h/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/9807980/
10 mg single, oral
dose: 10 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
DEXTROAMPHETAMINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
12 h
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/18021493/
70 mg 1 times / day multiple, oral
dose: 70 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
LISDEXAMFETAMINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
12.1 h
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/9807980/
10 mg single, oral
dose: 10 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
DEXTROAMPHETAMINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
12 h
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040361Orig1s017lbl.pdf
15 mg single, oral
dose: 15 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
DEXTROAMPHETAMINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 13 - 17
n = 233
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 13 - 17
Sex: M+F
Population Size: 233
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Disc. AE: Irritability, Decreased appetite...
AEs leading to
discontinuation/dose reduction:
Irritability (1.3%)
Decreased appetite (0.86%)
Insomnia (0.86%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
Disc. AE: Delirium, Tachycardia...
AEs leading to
discontinuation/dose reduction:
Delirium (acute)
Tachycardia
Hypertension
Tachypnea
Creatine kinase increased (mild)
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 18 - 55
n = 358
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 18 - 55
Sex: M+F
Population Size: 358
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Disc. AE: Insomnia, Tachycardia...
AEs leading to
discontinuation/dose reduction:
Insomnia (2%)
Tachycardia (1%)
Irritability (1%)
Hypertension (1%)
Headache (1%)
Anxiety (1%)
Dyspnea (1%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 6 - 12
n = 218
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 6 - 12
Sex: M+F
Population Size: 218
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Disc. AE: Ventricular hypertrophy, Tic...
AEs leading to
discontinuation/dose reduction:
Ventricular hypertrophy (1%)
Tic (1%)
Vomiting (1%)
Psychomotor hyperactivity (1%)
Insomnia (1%)
Rash (1%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
Other AEs: Decreased appetite, Insomnia...
Other AEs:
Decreased appetite (below serious, 29 patients)
Insomnia (below serious, 7 patients)
Weight decreased (below serious, 3 patients)
Irritability (below serious, 6 patients)
Fatigue (below serious, 4 patients)
Nasopharyngitis (below serious, 2 patients)
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
20 mg single, oral
Dose: 20 mg
Route: oral
Route: single
Dose: 20 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Other AEs: Nausea...
Other AEs:
Nausea (below serious, 1 patient)
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
50 mg single, oral
Dose: 50 mg
Route: oral
Route: single
Dose: 50 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Other AEs: Headache, Nausea...
Other AEs:
Headache (below serious, 4 patients)
Nausea (below serious, 1 patient)
Vomiting (below serious, 2 patients)
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
70 mg single, oral
Dose: 70 mg
Route: oral
Route: single
Dose: 70 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Other AEs: Headache, Nausea...
Other AEs:
Headache (below serious, 2 patients)
Nausea (below serious, 2 patients)
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Other AEs: Diarrhea, Dry mouth...
Other AEs:
Diarrhea (below serious, 6 patients)
Dry mouth (below serious, 25 patients)
Fatigue (below serious, 6 patients)
Feeling jittery (below serious, 10 patients)
Irritability (below serious, 8 patients)
Upper respiratory tract infection (below serious, 5 patients)
Heart rate increased (below serious, 4 patients)
Weight decreased (below serious, 8 patients)
Anorexia (below serious, 4 patients)
Decreased appetite (below serious, 26 patients)
Headache (below serious, 20 patients)
Initial insomnia (below serious, 8 patients)
Insomnia (below serious, 10 patients)
Libido decreased (below serious, 4 patients)
Hyperhidrosis (below serious, 5 patients)
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Disc. AE: Abuse, Dependence...
AEs leading to
discontinuation/dose reduction:
Abuse
Dependence
Cardiovascular disorder (NOS) (grade 3-5)
Stroke (serious)
Myocardial infarction (serious)
Blood pressure increased
Heart rate increased
Psychiatric symptom NOS
Psychotic symptom
Manic symptom
Growth suppression
Vascular disorders
Raynaud's phenomenon
Serotonin syndrome
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Other AEs: Decreased appetite, Dry mouth...
Other AEs:
Decreased appetite (below serious, 8 patients)
Dry mouth (below serious, 7 patients)
Insomnia (below serious, 10 patients)
Irritability (below serious, 3 patients)
Diaphoresis (below serious, 2 patients)
Libido decreased (below serious, 2 patients)
Tinnitus (below serious, 2 patients)
Muscle tension (below serious, 4 patients)
Tachycardia (below serious, 3 patients)
Paresthesia (below serious, 2 patients)
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
AEs

AEs

AESignificanceDosePopulation
Decreased appetite 0.86%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 13 - 17
n = 233
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 13 - 17
Sex: M+F
Population Size: 233
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Insomnia 0.86%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 13 - 17
n = 233
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 13 - 17
Sex: M+F
Population Size: 233
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Irritability 1.3%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 13 - 17
n = 233
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 13 - 17
Sex: M+F
Population Size: 233
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Hypertension Disc. AE
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
Tachycardia Disc. AE
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
Tachypnea Disc. AE
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
Delirium acute
Disc. AE
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
Creatine kinase increased mild
Disc. AE
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
Anxiety 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 18 - 55
n = 358
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 18 - 55
Sex: M+F
Population Size: 358
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Dyspnea 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 18 - 55
n = 358
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 18 - 55
Sex: M+F
Population Size: 358
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Headache 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 18 - 55
n = 358
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 18 - 55
Sex: M+F
Population Size: 358
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Hypertension 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 18 - 55
n = 358
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 18 - 55
Sex: M+F
Population Size: 358
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Irritability 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 18 - 55
n = 358
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 18 - 55
Sex: M+F
Population Size: 358
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Tachycardia 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 18 - 55
n = 358
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 18 - 55
Sex: M+F
Population Size: 358
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Insomnia 2%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 18 - 55
n = 358
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 18 - 55
Sex: M+F
Population Size: 358
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Insomnia 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 6 - 12
n = 218
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 6 - 12
Sex: M+F
Population Size: 218
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Psychomotor hyperactivity 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 6 - 12
n = 218
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 6 - 12
Sex: M+F
Population Size: 218
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Rash 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 6 - 12
n = 218
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 6 - 12
Sex: M+F
Population Size: 218
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Tic 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 6 - 12
n = 218
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 6 - 12
Sex: M+F
Population Size: 218
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Ventricular hypertrophy 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 6 - 12
n = 218
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 6 - 12
Sex: M+F
Population Size: 218
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Vomiting 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 6 - 12
n = 218
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 6 - 12
Sex: M+F
Population Size: 218
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Nasopharyngitis below serious, 2 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
Decreased appetite below serious, 29 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
Weight decreased below serious, 3 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
Fatigue below serious, 4 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
Irritability below serious, 6 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
Insomnia below serious, 7 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
Nausea below serious, 1 patient
20 mg single, oral
Dose: 20 mg
Route: oral
Route: single
Dose: 20 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Nausea below serious, 1 patient
50 mg single, oral
Dose: 50 mg
Route: oral
Route: single
Dose: 50 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Vomiting below serious, 2 patients
50 mg single, oral
Dose: 50 mg
Route: oral
Route: single
Dose: 50 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Headache below serious, 4 patients
50 mg single, oral
Dose: 50 mg
Route: oral
Route: single
Dose: 50 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Headache below serious, 2 patients
70 mg single, oral
Dose: 70 mg
Route: oral
Route: single
Dose: 70 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Nausea below serious, 2 patients
70 mg single, oral
Dose: 70 mg
Route: oral
Route: single
Dose: 70 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Feeling jittery below serious, 10 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Insomnia below serious, 10 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Headache below serious, 20 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Dry mouth below serious, 25 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Decreased appetite below serious, 26 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Anorexia below serious, 4 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Heart rate increased below serious, 4 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Libido decreased below serious, 4 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Hyperhidrosis below serious, 5 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Upper respiratory tract infection below serious, 5 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Diarrhea below serious, 6 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Fatigue below serious, 6 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Initial insomnia below serious, 8 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Irritability below serious, 8 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Weight decreased below serious, 8 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Abuse Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Blood pressure increased Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Dependence Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Growth suppression Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Heart rate increased Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Manic symptom Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Psychiatric symptom NOS Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Psychotic symptom Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Raynaud's phenomenon Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Serotonin syndrome Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Vascular disorders Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Cardiovascular disorder (NOS) grade 3-5
Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Myocardial infarction serious
Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Stroke serious
Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Insomnia below serious, 10 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Diaphoresis below serious, 2 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Libido decreased below serious, 2 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Paresthesia below serious, 2 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Tinnitus below serious, 2 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Irritability below serious, 3 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Tachycardia below serious, 3 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Muscle tension below serious, 4 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Dry mouth below serious, 7 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Decreased appetite below serious, 8 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
inhibitor
1587
inhibitor
1767
inhibitor
1852

substrate
1217

OverviewOther

Other InhibitorOther SubstrateOther Inducer
CYP1A2
1524

CYP2A6
707

CYP2B6
810

CYP2C19
1478
CYP
270
Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
CYP2D6
1891
 likely
CYP2C19
1553
 no [Inhibition 87.3 uM]
CYP2C9
1819
 no [Inhibition 89 uM]
CYP2D6
1891
 no [Inhibition 90 uM]
CYP2B6
1001
 no [Inhibition 90.8 uM]
CYP3A4
1925
 no [Inhibition 92.1 uM]
CYP2A6
739
 no [Inhibition 92.5 uM]
CYP1A2
1692
 no [Inhibition 94.2 uM]
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
CYP2D6
1217
 likely
likely (co-administration study)
Comment: Amphetamines and amphetamine derivatives are known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and display minor inhibition of CYP2D6 metabolism; concomitant use of DEXEDRINE and CYP2D6 inhibitors may increase the exposure of DEXEDRINE;
Page: 4.0
CYP
270
 no
Sourcing

Sourcing

Vendor/AggregatorIDURL
1PlusChem LLC
1P00E9T8
AA Blocks
AA00DRV1
https://www.aablocks.com/goods/Goods/detail?id=AA00DRV1
Alfa Chemistry
ACM608137333
Angene
AGN-PC-0WH4QC
Aurora Fine Chemicals LLC
A17.876.402
http://online.aurorafinechemicals.com/info?ID=A17.876.402
Aurora Fine Chemicals LLC
K16.670.581
http://online.aurorafinechemicals.com/info?ID=K16.670.581
Avantor Inc
101096-690
https://us.vwr.com/store/catalog/product.jsp?catalog_number=101096-690
Avantor Inc
75835-260
https://us.vwr.com/store/product/21998648/exempted-drug-of-abuse-reference-standards-restek
BioCrick
BCC5942
http://www.biocrick.com/D-Amphetamine-sulfate-BCC5942.html
Cayman Chemical
18050
ChemMol
44007218
http://www.chemmol.com/chemmol/44007218.html
Compound Cloud
11597697
Compound Cloud
11597698
LGC Standards
LGCFOR1359.00
https://www.lgcstandards.com/US/en/p/LGCFOR1359.00
LGC Standards
MM1359.00
https://www.lgcstandards.com/US/en/p/MM1359.00
MolPort
MolPort-046-693-343
Parchem
16880
http://www.parchem.com/chemical-supplier-distributor/DITAB-006880.aspx
Sigma Aldrich
L-026
Sigma Aldrich
L-026|CERILLIAN
Sigma-Aldrich
A3278_SIAL
https://www.sigmaaldrich.com/catalog/product/sial/a3278?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
Sigma-Aldrich
A5880_SIGMA
https://www.sigmaaldrich.com/catalog/product/sigma/a5880?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
Sigma-Aldrich
1180004_USP
https://www.sigmaaldrich.com/catalog/product/usp/1180004?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
Smolecule
S525797
http://www.smolecule.com/products/s525797
THE BioTek
bt-267390
https://www.thebiotek.com/product/inhibitors/bt-267390
THE BioTek
bt-386638
https://www.thebiotek.com/product/others/bt-386638
Tocris
2813
https://www.tocris.com/products/d-amphetamine-sulfate_2813
Toronto Research Chemicals
KIT2550
Toronto Research Chemicals
L468880
Toronto Research Chemicals
L468885
ZINC
ZINC000011680943
http://zinc15.docking.org/substances/ZINC000011680943
iChemical
EBD10545
http://www.ichemical.com/chemicals/cas-608137-33-3
iChemical
EBD2638102
http://www.ichemical.com/products/51-63-8.html?utm_source=PubChem&utm_medium=website&utm_campaign=product%20catalogs
mcule
MCULE-1818516035
mcule
MCULE-7002483605
PubMed

PubMed

TitleDatePubMed
Agonist and antagonist activity of low efficacy D2 dopamine receptor agonists in rats discriminating d-amphetamine from saline.
1992 Dec
Stimulation of metabotropic but not ionotropic glutamatergic receptors in the nucleus accumbens is required for the D-amphetamine-induced release of functional dopamine.
2001
Effects of systemic injections of dopaminergic agents on the habituation of rats submitted to an open field test.
2001
Effect of 6-hydroxydopamine or repeated amphetamine treatment on mesencephalic mRNA levels for AMPA glutamate receptor subunits in the rat.
2001 Apr 20
Neural mechanisms of motion sickness.
2001 Feb
Tyrosine improves behavioral and neurochemical deficits caused by cold exposure.
2001 Feb
Differences in locomotor response to an inescapable novel environment predict sensitivity to aversive effects of amphetamine.
2001 Feb
Effects of acute D-amphetamine and ketamine on the performance of rats in a serial negative patterning procedure.
2001 Feb
The D3R partial agonist, BP 897, attenuates the discriminative stimulus effects of cocaine and D-amphetamine and is not self-administered.
2001 Feb
Chronic inositol increases striatal D(2) receptors but does not modify dexamphetamine-induced motor behavior. Relevance to obsessive-compulsive disorder.
2001 Feb
Selective inhibition of amine oxidases differently potentiate the hypophagic effect of benzylamine in mice.
2001 Feb 9
Schedule-dependent effects of haloperidol and amphetamine: multiple-schedule task shows within-subject effects.
2001 Jan
Effects of d-amphetamine on the performance of rats in an animal analogue of the A-X continuous performance test.
2001 Mar
Acute myocardial infarction associated with amphetamine use.
2001 Mar
Lobeline inhibits the neurochemical and behavioral effects of amphetamine.
2001 Mar
Locomotor effects of acute and repeated threshold doses of amphetamine and methylphenidate: relative roles of dopamine and norepinephrine.
2001 Mar
Dopaminergic role in stimulant-induced wakefulness.
2001 Mar 1
Dissociations between the effects of intra-accumbens administration of amphetamine and exposure to a novel environment on accumbens dopamine and cortical acetylcholine release.
2001 Mar 16
Serotonin transporter localization in the hamster suprachiasmatic nucleus.
2001 Mar 2
Amphetamine-stimulated cortical acetylcholine release: role of the basal forebrain.
2001 Mar 9
Cocaine and amphetamine increase extracellular dopamine in the nucleus accumbens of mice lacking the dopamine transporter gene.
2001 May 1
Genes in drug abuse.
2001 May 1
Lisdexamfetamine.
2007
Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study.
2007 Nov 1
Substance use disorders in children and adolescents with attention-deficit/hyperactivity disorder: implications for treatment and the role of the primary care physician.
2008
Multiple daily-dose pharmacokinetics of lisdexamfetamine dimesylate in healthy adult volunteers.
2008 Jan
Pharmacologic treatment of ADHD: road conditions in driving patients to successful outcomes.
2008 Jan 8
Poison centers detect an unexpectedly frequent number of adverse drug reactions to lisdexamfetamine.
2008 Jul
Lisdexamfetamine dimesylate for childhood ADHD.
2008 May
Double-blind, placebo-controlled study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder.
2008 Sep
Alopecia following initiation of lisdexamfetamine in a pediatric patient.
2009
Update on the management of attention-deficit/hyperactivity disorder in children and adults: patient considerations and the role of lisdexamfetamine.
2009
Psychopharmacology of ADHD in pediatrics: current advances and issues.
2009
Lisdexamfetamine dimesylate: in attention-deficit hyperactivity disorder in adults.
2009
Lisdexamfetamine for treatment of attention-deficit/hyperactivity disorder.
2009 Apr
The neuropharmacology of ADHD drugs in vivo: insights on efficacy and safety.
2009 Dec
Case histories in pharmaceutical risk management.
2009 Dec 1
An update on central nervous system stimulant formulations in children and adolescents with attention-deficit/hyperactivity disorder.
2009 Jun
Human pharmacology of intravenous lisdexamfetamine dimesylate: abuse liability in adult stimulant abusers.
2009 Jun
Lisdexamfetamine: a prodrug for the treatment of attention-deficit/hyperactivity disorder.
2009 Nov 15
Lisdexamfetamine in the treatment of attention-deficit/hyperactivity disorder in adults.
2009 Oct
Attention-deficit hyperactivity disorder: recent advances in paediatric pharmacotherapy.
2010
Advances in the treatment of attention-deficit/hyperactivity disorder: a guide for pediatric neurologists.
2010 Dec
Eosinophilic hepatitis in an adolescent during lisdexamfetamine dimesylate treatment for ADHD.
2010 Jun
Absorption of lisdexamfetamine dimesylate and its enzymatic conversion to d-amphetamine.
2010 Jun 24
Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design.
2010 Jun 24
New and extended-action treatments in the management of ADHD: a critical appraisal of lisdexamfetamine in adults and children.
2010 May 25
Focus on Lisdexamfetamine: A Review of its use in Child and Adolescent Psychiatry.
2010 Nov
Use of psychostimulants in patients with dementia.
2010 Oct
Does prior exposure to stimulants in children with ADHD impact cardiovascular parameters from lisdexamfetamine dimesylate?
2010 Sep
Patents

Patents

04233217
12
08586575
12
08614346
12
20010007657
21
20010007673
19
20070042955
12
20080086016
14
JP2001504847A
40
JP2002511777A
414
JP2002541106A
98
JP2003521987A
21
JP2007509152A
34
JP2009531466A
75
JP2011529923A
42
JP2012012360A
19
JP4838730B2
19
JPS59132895A
12

Sample Use Guides

In Vivo Use Guide
Attention-deficit/hyperactivity disorder: Initial: 30 mg once daily in the morning; may increase in increments of 10 mg or 20 mg at weekly intervals until optimal response is obtained; maximum: 70 mg/day. Binge eating disorder: Initial: 30 mg once daily in the morning; may titrate in increments of 20 mg at weekly intervals to target dose of 50 to 70 mg once daily (maximum: 70 mg/day).
Route of Administration: Oral
In Vitro Use Guide
Curator's Comment: The action of several concentrations of d-amphetamine on the NADH-tetrazolium reductase histochemical reaction has been studied in several nervous regions of rats. The facts observed have demonstrated that d-amphetamine increases the intensity of the histochemical reaction by its action on NADH-oxido-reductase activity in all nervous regions studied.
Incubation of lisdexamfetamine in microsomal suspensions at concentrations ranging from 0.01 to 100 M showed no concentration-dependent inhibition for any of the isoenzymes under investigation (CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A, CYP3A4).
Name Type Language
LISDEXAMFETAMINE DIMESYLATE
ORANGE BOOK   USAN   VANDF  
USAN  
Official Name English
NRP104
Code English
(2S)-2,6-DIAMINO-N-((1S)-1-METHYL-2-PHENYLETHYL)HEXANAMIDE DIMETHANESULPHONATE
Systematic Name English
VYVANSE
Brand Name English
Lisdexamfetamine Mesilate [WHO-DD]
Common Name English
HEXANAMIDE, 2,6-DIAMINO-N-((1S)-1-METHYL-2-PHENYLETHYL), (2S), DIMETHANESULPHONATE
Common Name English
SPD-489
Code English
LISDEXAMFETAMINE DIMESYLATE [USAN]
Common Name English
HEXANAMIDE, 2,6-DIAMINO-N-((1S)-1-METHYL-2-PHENYLETHYL), (2S), DIMETHANESULFONATE
Common Name English
LISDEXAMFETAMINE DIMETHANESULFONATE [MI]
Common Name English
LISDEXAMFETAMINE DIMESYLATE [ORANGE BOOK]
Common Name English
LISDEXAMFETAMINE MESILATE [MART.]
Common Name English
LISDEXAMFETAMINE DIMESYLATE [VANDF]
Common Name English
TYVENSE
Brand Name English
SPD489
Code English
LISDEXAMFETAMINE MESILATE
MART.   WHO-DD  
Common Name English
LISDEXAMFETAMINE DIMETHANESULFONATE
MI  
Common Name English
LISDEXAMFETAMINE MESILATE [JAN]
Common Name English
(2S)-2,6-Diamino-N-[(1S)-1-methyl-2-phenylethyl]hexanamide dimethanesulfonate
Systematic Name English
NRP-104
Code English
LISDEXAMPHETAMINE DIMESILATE
Common Name English
LISDEXAMFETAMINE DIMESILATE
Common Name English
Classification Tree Code System Code
DEA NO. 1205
Created by admin on Fri Dec 15 15:52:55 GMT 2023 , Edited by admin on Fri Dec 15 15:52:55 GMT 2023
NCI_THESAURUS C29728
Created by admin on Fri Dec 15 15:52:55 GMT 2023 , Edited by admin on Fri Dec 15 15:52:55 GMT 2023
NCI_THESAURUS C47795
Created by admin on Fri Dec 15 15:52:55 GMT 2023 , Edited by admin on Fri Dec 15 15:52:55 GMT 2023
Code System Code Type Description
USAN
QQ-95
Created by admin on Fri Dec 15 15:52:55 GMT 2023 , Edited by admin on Fri Dec 15 15:52:55 GMT 2023
PRIMARY
SMS_ID
100000124520
Created by admin on Fri Dec 15 15:52:55 GMT 2023 , Edited by admin on Fri Dec 15 15:52:55 GMT 2023
PRIMARY
DAILYMED
SJT761GEGS
Created by admin on Fri Dec 15 15:52:55 GMT 2023 , Edited by admin on Fri Dec 15 15:52:55 GMT 2023
PRIMARY
CAS
608137-33-3
Created by admin on Fri Dec 15 15:52:55 GMT 2023 , Edited by admin on Fri Dec 15 15:52:55 GMT 2023
PRIMARY
ChEMBL
CHEMBL1201222
Created by admin on Fri Dec 15 15:52:55 GMT 2023 , Edited by admin on Fri Dec 15 15:52:55 GMT 2023
PRIMARY
MERCK INDEX
m6841
Created by admin on Fri Dec 15 15:52:55 GMT 2023 , Edited by admin on Fri Dec 15 15:52:55 GMT 2023
PRIMARY Merck Index
FDA UNII
SJT761GEGS
Created by admin on Fri Dec 15 15:52:55 GMT 2023 , Edited by admin on Fri Dec 15 15:52:55 GMT 2023
PRIMARY
DRUG BANK
DBSALT002824
Created by admin on Fri Dec 15 15:52:55 GMT 2023 , Edited by admin on Fri Dec 15 15:52:55 GMT 2023
PRIMARY
PUBCHEM
11597697
Created by admin on Fri Dec 15 15:52:55 GMT 2023 , Edited by admin on Fri Dec 15 15:52:55 GMT 2023
PRIMARY
MESH
C514020
Created by admin on Fri Dec 15 15:52:55 GMT 2023 , Edited by admin on Fri Dec 15 15:52:55 GMT 2023
PRIMARY
NCI_THESAURUS
C76628
Created by admin on Fri Dec 15 15:52:55 GMT 2023 , Edited by admin on Fri Dec 15 15:52:55 GMT 2023
PRIMARY
EVMPD
SUB32146
Created by admin on Fri Dec 15 15:52:55 GMT 2023 , Edited by admin on Fri Dec 15 15:52:55 GMT 2023
PRIMARY
RXCUI
673579
Created by admin on Fri Dec 15 15:52:55 GMT 2023 , Edited by admin on Fri Dec 15 15:52:55 GMT 2023
PRIMARY RxNorm
EPA CompTox
DTXSID60209653
Created by admin on Fri Dec 15 15:52:55 GMT 2023 , Edited by admin on Fri Dec 15 15:52:55 GMT 2023
PRIMARY
PARENT (SALT/SOLVATE)
Structure of LISDEXAMFETAMINE
NIH
NCATS
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