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Details

Stereochemistry ABSOLUTE
Molecular Formula C15H25N3O
Molecular Weight 263.3791
Optical Activity UNSPECIFIED
Defined Stereocenters 2 / 2
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of LISDEXAMFETAMINE

SMILES

C[C@@]([H])(Cc1ccccc1)N=C([C@]([H])(CCCCN)N)O

InChI

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

HIDE SMILES / InChI

Description
Curator's Comment:: description was created based on several sources, including: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021977lbl.pdf | https://www.drugs.com/ppa/lisdexamfetamine.html | https://www.ncbi.nlm.nih.gov/pubmed/27125257

Lisdexamfetamine (LDX) is a d-amphetamine (d-AMPH) pro-drug used to treat Attention Deficit and Hyperactivity Disorder (ADHD) and Binge Eating Disorder (BED). After oral administration, lisdexamfetamine dimesylate is rapidly absorbed from the gastrointestinal tract and converted to dextroamphetamine, which is responsible for the drug’s activity. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. Most common adverse reactions in children, adolescents and/or adults with ADHD were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting. Agents that alter urinary pH can alter blood levels of amphetamine. Acidifying agents decrease amphetamine blood levels, while alkalinizing agents increase amphetamine blood levels. Needs to adjust Lisdexamfetamine dosage accordingly.

Originator

Curator's Comment:: New River Pharmaceuticals was bought by Shire Pharmaceuticals

Approval Year

TargetsConditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
VYVANSE

Approved Use

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

Launch Date

1.17218882E12
Primary
VYVANSE

Approved Use

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

Launch Date

1.17218882E12
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
47.9 ng/mL
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
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
60.7 ng × h/mL
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
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
12 h
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
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: 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: 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: Page: p.8
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources: Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources: Page: e771
Disc. AE: Delirium, Tachycardia...
AEs leading to
discontinuation/dose reduction:
Delirium (acute)
Tachycardia
Hypertension
Tachypnea
Creatine kinase increased (mild)
Sources: 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: 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: 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: 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: 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: 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: 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:
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
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:
20 mg single, oral
Dose: 20 mg
Route: oral
Route: single
Dose: 20 mg
Sources:
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
Other AEs: Nausea...
Other AEs:
Nausea (below serious, 1 patient)
Sources:
50 mg single, oral
Dose: 50 mg
Route: oral
Route: single
Dose: 50 mg
Sources:
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
Other AEs: Headache, Nausea...
Other AEs:
Headache (below serious, 4 patients)
Nausea (below serious, 1 patient)
Vomiting (below serious, 2 patients)
Sources:
70 mg single, oral
Dose: 70 mg
Route: oral
Route: single
Dose: 70 mg
Sources:
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
Other AEs: Headache, Nausea...
Other AEs:
Headache (below serious, 2 patients)
Nausea (below serious, 2 patients)
Sources:
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:
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
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:
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: Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources: 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: 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:
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
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:
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: 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: 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: 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: 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: 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: Page: p.8
Hypertension Disc. AE
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources: Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources: Page: e771
Tachycardia Disc. AE
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources: Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources: Page: e771
Tachypnea Disc. AE
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources: Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources: Page: e771
Delirium acute
Disc. AE
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources: Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources: Page: e771
Creatine kinase increased mild
Disc. AE
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources: Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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:
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
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:
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
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:
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
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:
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
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:
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
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:
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
Nausea below serious, 1 patient
20 mg single, oral
Dose: 20 mg
Route: oral
Route: single
Dose: 20 mg
Sources:
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
Nausea below serious, 1 patient
50 mg single, oral
Dose: 50 mg
Route: oral
Route: single
Dose: 50 mg
Sources:
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
Vomiting below serious, 2 patients
50 mg single, oral
Dose: 50 mg
Route: oral
Route: single
Dose: 50 mg
Sources:
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
Headache below serious, 4 patients
50 mg single, oral
Dose: 50 mg
Route: oral
Route: single
Dose: 50 mg
Sources:
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
Headache below serious, 2 patients
70 mg single, oral
Dose: 70 mg
Route: oral
Route: single
Dose: 70 mg
Sources:
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
Nausea below serious, 2 patients
70 mg single, oral
Dose: 70 mg
Route: oral
Route: single
Dose: 70 mg
Sources:
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
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:
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
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:
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
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:
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
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:
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
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:
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
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:
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
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:
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
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:
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
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:
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
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:
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
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:
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
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:
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
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:
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
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:
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
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:
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
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: Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources: 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: Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources: 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: Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources: 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: Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources: 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: Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources: 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: Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources: 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: Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources: 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: Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources: 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: Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources: 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: Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources: 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: Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources: 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: Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources: 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: Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources: 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: Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources: 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:
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
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:
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
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:
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
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:
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
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:
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
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:
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
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:
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
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:
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
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:
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
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:
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG



OverviewOther

Other InhibitorOther SubstrateOther Inducer





Drug as perpetrator​Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
no
PubMed

PubMed

TitleDatePubMed
Lisdexamfetamine.
2007
An evaluation of the cytochrome p450 inhibition potential of lisdexamfetamine in human liver microsomes.
2007 Jan
Schedules of controlled substances: placement of lisdexamfetamine into schedule II. Final rule.
2007 May 3
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
Lisdexamfetamine: a prodrug stimulant for ADHD.
2008 Aug
Poison centers detect an unexpectedly frequent number of adverse drug reactions to lisdexamfetamine.
2008 Jul
Relative bioavailability of lisdexamfetamine 70-mg capsules in fasted and fed healthy adult volunteers and in solution: a single-dose, crossover pharmacokinetic study.
2008 Mar
Lisdexamfetamine dimesylate for childhood ADHD.
2008 May
Attention-deficit-hyperactivity disorder and reward deficiency syndrome.
2008 Oct
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
Effect of lisdexamfetamine dimesylate on sleep in adults with attention-deficit/hyperactivity disorder.
2009 Aug 3
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
A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder.
2009 Jun 9
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

Sample Use Guides

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
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
INN   MI   VANDF   WHO-DD  
INN  
Official Name English
L-LYSINE-DEXTROAMPHETAMINE
Common Name English
LISDEXAMPHETAMINE
Common Name English
LISDEXAMFETAMINE [INN]
Common Name English
LISDEXAMFETAMINE [WHO-DD]
Common Name English
HEXANAMIDE, 2,6-DIAMINO-N-((1S)-1-METHYL-2-PHENYLETHYL)-, (2S)-
Systematic Name English
(2S)-2,6-DIAMINO-N-((1S)-1-METHYL-2-PHENYLETHYL)HEXANAMIDE
Systematic Name English
LISDEXAMFETAMINE [VANDF]
Common Name English
LISDEXAMFETAMINE [MI]
Common Name English
Classification Tree Code System Code
NDF-RT N0000175739
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
NCI_THESAURUS C29728
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
NDF-RT N0000175729
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
DEA NO. 1205
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
WHO-ATC N06BA12
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
WHO-VATC QN06BA12
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
LIVERTOX 562
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
Code System Code Type Description
PUBCHEM
11597698
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
DRUG BANK
DB01255
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
NCI_THESAURUS
C75114
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
IUPHAR
7213
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
RXCUI
700810
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY RxNorm
MERCK INDEX
M6841
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY Merck Index
EVMPD
SUB32170
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
WIKIPEDIA
LISDEXAMFETAMINE
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
INN
8690
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
DRUG CENTRAL
4135
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
LACTMED
Lisdexamfetamine
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
EPA CompTox
608137-32-2
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
CAS
608137-32-2
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
ChEMBL
CHEMBL1201222
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
FDA UNII
H645GUL8KJ
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY