Details
Stereochemistry | ABSOLUTE |
Molecular Formula | C15H25N3O |
Molecular Weight | 263.3785 |
Optical Activity | UNSPECIFIED |
Defined Stereocenters | 2 / 2 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
C[C@@H](CC1=CC=CC=C1)NC(=O)[C@@H](N)CCCCN
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
Molecular Formula | C15H25N3O |
Molecular Weight | 263.3785 |
Charge | 0 |
Count |
|
Stereochemistry | ABSOLUTE |
Additional Stereochemistry | No |
Defined Stereocenters | 2 / 2 |
E/Z Centers | 0 |
Optical Activity | UNSPECIFIED |
DescriptionSources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017078s048lbl.pdfhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdfCurator'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
Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017078s048lbl.pdfhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
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
Sources: http://www.chemeurope.com/en/encyclopedia/dextroamphetamine.htmlhttp://adisinsight.springer.com/drugs/800020876
Curator's Comment: New River Pharmaceuticals was bought by Shire Pharmaceuticals
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: GO:0050432 |
|||
Target ID: CHEMBL222 Sources: https://www.ncbi.nlm.nih.gov/pubmed/17239355 |
|||
Target ID: CHEMBL1893 Sources: https://www.ncbi.nlm.nih.gov/pubmed/7751968 |
|||
Target ID: CHEMBL238 Sources: https://www.ncbi.nlm.nih.gov/pubmed/19244097 |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Primary | VYVANSE Approved UseVYVANSE® is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14.1) Launch Date2007 |
|||
Primary | VYVANSE Approved UseVYVANSE® is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14.1) Launch Date2007 |
|||
Primary | DEXEDRINE Approved UseNarcolepsy. 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 Date1980 |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
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 |
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
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
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
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
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 |
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
Dose | Population | Adverse events |
---|---|---|
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: |
unhealthy, 13 - 17 Health Status: unhealthy Age Group: 13 - 17 Sex: M+F Sources: |
Disc. AE: Irritability, Decreased appetite... AEs leading to discontinuation/dose reduction: Irritability (1.3%) Sources: Decreased appetite (0.86%) Insomnia (0.86%) |
1200 mg single, oral Overdose |
healthy, 17 |
Disc. AE: Delirium, Tachycardia... AEs leading to discontinuation/dose reduction: Delirium (acute) Sources: Tachycardia Hypertension Tachypnea Creatine kinase increased (mild) |
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: |
unhealthy, 18 - 55 Health Status: unhealthy Age Group: 18 - 55 Sex: M+F Sources: |
Disc. AE: Insomnia, Tachycardia... AEs leading to discontinuation/dose reduction: Insomnia (2%) Sources: Tachycardia (1%) Irritability (1%) Hypertension (1%) Headache (1%) Anxiety (1%) Dyspnea (1%) |
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: |
unhealthy, 6 - 12 Health Status: unhealthy Age Group: 6 - 12 Sex: M+F Sources: |
Disc. AE: Ventricular hypertrophy, Tic... AEs leading to discontinuation/dose reduction: Ventricular hypertrophy (1%) Sources: Tic (1%) Vomiting (1%) Psychomotor hyperactivity (1%) Insomnia (1%) Rash (1%) |
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 Health Status: unhealthy Age Group: adolescents Sources: |
Other AEs: Decreased appetite, Insomnia... Other AEs: Decreased appetite (below serious, 29 patients) Sources: 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) |
20 mg single, oral Dose: 20 mg Route: oral Route: single Dose: 20 mg Sources: |
healthy, adult Health Status: healthy Age Group: adult Sex: M Sources: |
Other AEs: Nausea... |
50 mg single, oral Dose: 50 mg Route: oral Route: single Dose: 50 mg Sources: |
healthy, adult Health Status: healthy Age Group: adult Sex: M Sources: |
Other AEs: Headache, Nausea... Other AEs: Headache (below serious, 4 patients) Sources: Nausea (below serious, 1 patient) Vomiting (below serious, 2 patients) |
70 mg single, oral Dose: 70 mg Route: oral Route: single Dose: 70 mg Sources: |
healthy, adult Health Status: healthy Age Group: adult Sex: M Sources: |
Other AEs: Headache, Nausea... Other AEs: Headache (below serious, 2 patients) Sources: Nausea (below serious, 2 patients) |
70 mg 1 times / day steady, oral Dose: 70 mg, 1 times / day Route: oral Route: steady Dose: 70 mg, 1 times / day Sources: |
unhealthy, adult |
Other AEs: Diarrhea, Dry mouth... Other AEs: Diarrhea (below serious, 6 patients) Sources: 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) |
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: |
unhealthy Health Status: unhealthy Sources: |
Disc. AE: Abuse, Dependence... AEs leading to discontinuation/dose reduction: Abuse Sources: 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 |
50 mg 1 times / day steady, oral Dose: 50 mg, 1 times / day Route: oral Route: steady Dose: 50 mg, 1 times / day Sources: |
unhealthy |
Other AEs: Decreased appetite, Dry mouth... Other AEs: Decreased appetite (below serious, 8 patients) Sources: 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) |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Decreased appetite | 0.86% 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: |
unhealthy, 13 - 17 Health Status: unhealthy Age Group: 13 - 17 Sex: M+F Sources: |
Insomnia | 0.86% 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: |
unhealthy, 13 - 17 Health Status: unhealthy Age Group: 13 - 17 Sex: M+F Sources: |
Irritability | 1.3% 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: |
unhealthy, 13 - 17 Health Status: unhealthy Age Group: 13 - 17 Sex: M+F Sources: |
Hypertension | Disc. AE | 1200 mg single, oral Overdose |
healthy, 17 |
Tachycardia | Disc. AE | 1200 mg single, oral Overdose |
healthy, 17 |
Tachypnea | Disc. AE | 1200 mg single, oral Overdose |
healthy, 17 |
Delirium | acute Disc. AE |
1200 mg single, oral Overdose |
healthy, 17 |
Creatine kinase increased | mild Disc. AE |
1200 mg single, oral Overdose |
healthy, 17 |
Anxiety | 1% 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: |
unhealthy, 18 - 55 Health Status: unhealthy Age Group: 18 - 55 Sex: M+F Sources: |
Dyspnea | 1% 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: |
unhealthy, 18 - 55 Health Status: unhealthy Age Group: 18 - 55 Sex: M+F Sources: |
Headache | 1% 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: |
unhealthy, 18 - 55 Health Status: unhealthy Age Group: 18 - 55 Sex: M+F Sources: |
Hypertension | 1% 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: |
unhealthy, 18 - 55 Health Status: unhealthy Age Group: 18 - 55 Sex: M+F Sources: |
Irritability | 1% 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: |
unhealthy, 18 - 55 Health Status: unhealthy Age Group: 18 - 55 Sex: M+F Sources: |
Tachycardia | 1% 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: |
unhealthy, 18 - 55 Health Status: unhealthy Age Group: 18 - 55 Sex: M+F Sources: |
Insomnia | 2% 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: |
unhealthy, 18 - 55 Health Status: unhealthy Age Group: 18 - 55 Sex: M+F Sources: |
Insomnia | 1% 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: |
unhealthy, 6 - 12 Health Status: unhealthy Age Group: 6 - 12 Sex: M+F Sources: |
Psychomotor hyperactivity | 1% 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: |
unhealthy, 6 - 12 Health Status: unhealthy Age Group: 6 - 12 Sex: M+F Sources: |
Rash | 1% 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: |
unhealthy, 6 - 12 Health Status: unhealthy Age Group: 6 - 12 Sex: M+F Sources: |
Tic | 1% 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: |
unhealthy, 6 - 12 Health Status: unhealthy Age Group: 6 - 12 Sex: M+F Sources: |
Ventricular hypertrophy | 1% 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: |
unhealthy, 6 - 12 Health Status: unhealthy Age Group: 6 - 12 Sex: M+F Sources: |
Vomiting | 1% 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: |
unhealthy, 6 - 12 Health Status: unhealthy Age Group: 6 - 12 Sex: M+F Sources: |
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 Health Status: unhealthy Age Group: adolescents 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 Health Status: unhealthy Age Group: adolescents 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 Health Status: unhealthy Age Group: adolescents 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 Health Status: unhealthy Age Group: adolescents 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 Health Status: unhealthy Age Group: adolescents 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 Health Status: unhealthy Age Group: adolescents Sources: |
Nausea | below serious, 1 patient | 20 mg single, oral Dose: 20 mg Route: oral Route: single Dose: 20 mg Sources: |
healthy, adult Health Status: healthy Age Group: adult Sex: M Sources: |
Nausea | below serious, 1 patient | 50 mg single, oral Dose: 50 mg Route: oral Route: single Dose: 50 mg Sources: |
healthy, adult Health Status: healthy Age Group: adult Sex: M Sources: |
Vomiting | below serious, 2 patients | 50 mg single, oral Dose: 50 mg Route: oral Route: single Dose: 50 mg Sources: |
healthy, adult Health Status: healthy Age Group: adult Sex: M Sources: |
Headache | below serious, 4 patients | 50 mg single, oral Dose: 50 mg Route: oral Route: single Dose: 50 mg Sources: |
healthy, adult Health Status: healthy Age Group: adult Sex: M Sources: |
Headache | below serious, 2 patients | 70 mg single, oral Dose: 70 mg Route: oral Route: single Dose: 70 mg Sources: |
healthy, adult Health Status: healthy Age Group: adult Sex: M Sources: |
Nausea | below serious, 2 patients | 70 mg single, oral Dose: 70 mg Route: oral Route: single Dose: 70 mg Sources: |
healthy, adult Health Status: healthy Age Group: adult Sex: M Sources: |
Feeling jittery | below serious, 10 patients | 70 mg 1 times / day steady, oral Dose: 70 mg, 1 times / day Route: oral Route: steady Dose: 70 mg, 1 times / day Sources: |
unhealthy, adult |
Insomnia | below serious, 10 patients | 70 mg 1 times / day steady, oral Dose: 70 mg, 1 times / day Route: oral Route: steady Dose: 70 mg, 1 times / day Sources: |
unhealthy, adult |
Headache | below serious, 20 patients | 70 mg 1 times / day steady, oral Dose: 70 mg, 1 times / day Route: oral Route: steady Dose: 70 mg, 1 times / day Sources: |
unhealthy, adult |
Dry mouth | below serious, 25 patients | 70 mg 1 times / day steady, oral Dose: 70 mg, 1 times / day Route: oral Route: steady Dose: 70 mg, 1 times / day Sources: |
unhealthy, adult |
Decreased appetite | below serious, 26 patients | 70 mg 1 times / day steady, oral Dose: 70 mg, 1 times / day Route: oral Route: steady Dose: 70 mg, 1 times / day Sources: |
unhealthy, adult |
Anorexia | below serious, 4 patients | 70 mg 1 times / day steady, oral Dose: 70 mg, 1 times / day Route: oral Route: steady Dose: 70 mg, 1 times / day Sources: |
unhealthy, adult |
Heart rate increased | below serious, 4 patients | 70 mg 1 times / day steady, oral Dose: 70 mg, 1 times / day Route: oral Route: steady Dose: 70 mg, 1 times / day Sources: |
unhealthy, adult |
Libido decreased | below serious, 4 patients | 70 mg 1 times / day steady, oral Dose: 70 mg, 1 times / day Route: oral Route: steady Dose: 70 mg, 1 times / day Sources: |
unhealthy, adult |
Hyperhidrosis | below serious, 5 patients | 70 mg 1 times / day steady, oral Dose: 70 mg, 1 times / day Route: oral Route: steady Dose: 70 mg, 1 times / day Sources: |
unhealthy, adult |
Upper respiratory tract infection | below serious, 5 patients | 70 mg 1 times / day steady, oral Dose: 70 mg, 1 times / day Route: oral Route: steady Dose: 70 mg, 1 times / day Sources: |
unhealthy, adult |
Diarrhea | below serious, 6 patients | 70 mg 1 times / day steady, oral Dose: 70 mg, 1 times / day Route: oral Route: steady Dose: 70 mg, 1 times / day Sources: |
unhealthy, adult |
Fatigue | below serious, 6 patients | 70 mg 1 times / day steady, oral Dose: 70 mg, 1 times / day Route: oral Route: steady Dose: 70 mg, 1 times / day Sources: |
unhealthy, adult |
Initial insomnia | below serious, 8 patients | 70 mg 1 times / day steady, oral Dose: 70 mg, 1 times / day Route: oral Route: steady Dose: 70 mg, 1 times / day Sources: |
unhealthy, adult |
Irritability | below serious, 8 patients | 70 mg 1 times / day steady, oral Dose: 70 mg, 1 times / day Route: oral Route: steady Dose: 70 mg, 1 times / day Sources: |
unhealthy, adult |
Weight decreased | below serious, 8 patients | 70 mg 1 times / day steady, oral Dose: 70 mg, 1 times / day Route: oral Route: steady Dose: 70 mg, 1 times / day Sources: |
unhealthy, adult |
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: |
unhealthy Health Status: unhealthy Sources: |
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: |
unhealthy Health Status: unhealthy Sources: |
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: |
unhealthy Health Status: unhealthy Sources: |
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: |
unhealthy Health Status: unhealthy Sources: |
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: |
unhealthy Health Status: unhealthy Sources: |
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: |
unhealthy Health Status: unhealthy Sources: |
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: |
unhealthy Health Status: unhealthy Sources: |
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: |
unhealthy Health Status: unhealthy Sources: |
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: |
unhealthy Health Status: unhealthy Sources: |
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: |
unhealthy Health Status: unhealthy Sources: |
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: |
unhealthy Health Status: unhealthy Sources: |
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: |
unhealthy Health Status: unhealthy Sources: |
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: |
unhealthy Health Status: unhealthy Sources: |
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: |
unhealthy Health Status: unhealthy Sources: |
Insomnia | below serious, 10 patients | 50 mg 1 times / day steady, oral Dose: 50 mg, 1 times / day Route: oral Route: steady Dose: 50 mg, 1 times / day Sources: |
unhealthy |
Diaphoresis | below serious, 2 patients | 50 mg 1 times / day steady, oral Dose: 50 mg, 1 times / day Route: oral Route: steady Dose: 50 mg, 1 times / day Sources: |
unhealthy |
Libido decreased | below serious, 2 patients | 50 mg 1 times / day steady, oral Dose: 50 mg, 1 times / day Route: oral Route: steady Dose: 50 mg, 1 times / day Sources: |
unhealthy |
Paresthesia | below serious, 2 patients | 50 mg 1 times / day steady, oral Dose: 50 mg, 1 times / day Route: oral Route: steady Dose: 50 mg, 1 times / day Sources: |
unhealthy |
Tinnitus | below serious, 2 patients | 50 mg 1 times / day steady, oral Dose: 50 mg, 1 times / day Route: oral Route: steady Dose: 50 mg, 1 times / day Sources: |
unhealthy |
Irritability | below serious, 3 patients | 50 mg 1 times / day steady, oral Dose: 50 mg, 1 times / day Route: oral Route: steady Dose: 50 mg, 1 times / day Sources: |
unhealthy |
Tachycardia | below serious, 3 patients | 50 mg 1 times / day steady, oral Dose: 50 mg, 1 times / day Route: oral Route: steady Dose: 50 mg, 1 times / day Sources: |
unhealthy |
Muscle tension | below serious, 4 patients | 50 mg 1 times / day steady, oral Dose: 50 mg, 1 times / day Route: oral Route: steady Dose: 50 mg, 1 times / day Sources: |
unhealthy |
Dry mouth | below serious, 7 patients | 50 mg 1 times / day steady, oral Dose: 50 mg, 1 times / day Route: oral Route: steady Dose: 50 mg, 1 times / day Sources: |
unhealthy |
Decreased appetite | below serious, 8 patients | 50 mg 1 times / day steady, oral Dose: 50 mg, 1 times / day Route: oral Route: steady Dose: 50 mg, 1 times / day Sources: |
unhealthy |
Overview
CYP3A4 | CYP2C9 | CYP2D6 | hERG |
---|---|---|---|
OverviewOther
Other Inhibitor | Other Substrate | Other Inducer |
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Drug as perpetrator
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
likely | ||||
Page: 7, 78 |
no [Inhibition 87.3 uM] | |||
Page: 7, 78 |
no [Inhibition 89 uM] | |||
Page: 7, 78 |
no [Inhibition 90 uM] | |||
Page: 7, 78 |
no [Inhibition 90.8 uM] | |||
Page: 7, 78 |
no [Inhibition 92.1 uM] | |||
Page: 7, 78 |
no [Inhibition 92.5 uM] | |||
Page: 7, 78 |
no [Inhibition 94.2 uM] |
Drug as victim
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
Page: 4.0 |
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 |
||
Page: 21.0 |
no |
PubMed
Title | Date | PubMed |
---|---|---|
Effects of systemic injections of dopaminergic agents on the habituation of rats submitted to an open field test. | 2001 |
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Determination of amphetamine in dog plasma by gas chromatography with mass selective detection. | 2001 Apr |
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Tyrosine improves behavioral and neurochemical deficits caused by cold exposure. | 2001 Feb |
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Differences in locomotor response to an inescapable novel environment predict sensitivity to aversive effects of amphetamine. | 2001 Feb |
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Effects of acute D-amphetamine and ketamine on the performance of rats in a serial negative patterning procedure. | 2001 Feb |
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The D3R partial agonist, BP 897, attenuates the discriminative stimulus effects of cocaine and D-amphetamine and is not self-administered. | 2001 Feb |
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Chronic inositol increases striatal D(2) receptors but does not modify dexamphetamine-induced motor behavior. Relevance to obsessive-compulsive disorder. | 2001 Feb |
|
Relevance of pharmacokinetic parameters in animal models of methamphetamine abuse. | 2001 Feb |
|
The reverse transport of DA, what physiological significance? | 2001 Feb |
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Highly sensitive analysis of methamphetamine and amphetamine in human whole blood using headspace solid-phase microextraction and gas chromatography-mass spectrometry. | 2001 Feb 1 |
|
Acute hydrocortisone administration does not affect subjective responses to d-amphetamine in humans. | 2001 Jan |
|
Distinct contributions of glutamate and dopamine receptors to temporal aspects of rodent working memory using a clinically relevant task. | 2001 Jan |
|
Modification of d-amphetamine-induced responses by baclofen in rats. | 2001 Jan |
|
Placebo-controlled evaluation of amphetamine mixture-dextroamphetamine salts and amphetamine salts (Adderall): efficacy rate and side effects. | 2001 Jan |
|
Behavioural and anti-psychotic effects of Ca2+ channel blockers in rhesus monkey. | 2001 Jan 26 |
|
Differential effects of endomorphin-1 and -2 on amphetamine sensitization: neurochemical and behavioral aspects. | 2001 Mar 1 |
|
Pharmacologic treatment of ADHD: road conditions in driving patients to successful outcomes. | 2008 Jan 8 |
|
Alopecia following initiation of lisdexamfetamine in a pediatric patient. | 2009 |
|
Psychopharmacology of ADHD in pediatrics: current advances and issues. | 2009 |
|
Case histories in pharmaceutical risk management. | 2009 Dec 1 |
|
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 |
Sample Use Guides
Usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response. Narcolepsy seldom occurs in children under 12 years of age; however, when it does, DEXEDRINE may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until an optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until an optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. SPANSULE capsules may be used for once-a-day dosage wherever appropriate.
Route of Administration:
Oral
In Vitro Use Guide
Sources: https://www.ncbi.nlm.nih.gov/pubmed/6428136
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.
Unknown
Substance Class |
Chemical
Created
by
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on
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Record UNII |
H645GUL8KJ
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Record Status |
Validated (UNII)
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Record Version |
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Classification Tree | Code System | Code | ||
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NDF-RT |
N0000175739
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NCI_THESAURUS |
C29728
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NDF-RT |
N0000175729
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DEA NO. |
1205
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WHO-ATC |
N06BA12
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WHO-VATC |
QN06BA12
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LIVERTOX |
562
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Code System | Code | Type | Description | ||
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11597698
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PRIMARY | |||
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H645GUL8KJ
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PRIMARY | |||
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DB01255
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PRIMARY | |||
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C75114
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PRIMARY | |||
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7213
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PRIMARY | |||
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700810
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PRIMARY | RxNorm | ||
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m6841
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PRIMARY | Merck Index | ||
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SUB32170
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PRIMARY | |||
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100000124476
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PRIMARY | |||
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LISDEXAMFETAMINE
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PRIMARY | |||
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8690
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PRIMARY | |||
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4135
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PRIMARY | |||
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Lisdexamfetamine
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PRIMARY | |||
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DTXSID00209652
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PRIMARY | |||
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608137-32-2
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PRIMARY | |||
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CHEMBL1201222
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PRIMARY | |||
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H645GUL8KJ
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PRIMARY |
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EXCRETED UNCHANGED |
URINE
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SALT/SOLVATE -> PARENT |
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SALT/SOLVATE -> PARENT |
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METABOLITE -> PARENT |
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METABOLITE -> PARENT |
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METABOLITE -> PARENT |
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METABOLITE ACTIVE -> PRODRUG |
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METABOLITE -> PARENT |
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METABOLITE -> PARENT |
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METABOLITE -> PARENT |
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ACTIVE MOIETY |
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Name | Property Type | Amount | Referenced Substance | Defining | Parameters | References |
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Biological Half-life | PHARMACOKINETIC |
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Tmax | PHARMACOKINETIC |
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