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
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
DescriptionCurator'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
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.
CNS Activity
Originator
Sources: http://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 |
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 Date1.17218882E12 |
|||
Primary | VYVANSE Approved UseVYVANSE® is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14.1) Launch Date1.17218882E12 |
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 |
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 |
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 |
Doses
Dose | Population | Adverse 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%) Sources: Page: p.8Decreased appetite (0.86%) Insomnia (0.86%) |
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) Sources: Page: e771Tachycardia Hypertension Tachypnea Creatine kinase increased (mild) |
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%) Sources: Page: p.8Tachycardia (1%) Irritability (1%) Hypertension (1%) Headache (1%) Anxiety (1%) Dyspnea (1%) |
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%) Sources: Page: p.8Tic (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 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) 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 n = 27 Health Status: healthy Condition: Acute Sleep Loss Age Group: adult Sex: M Population Size: 27 Sources: |
Other AEs: Nausea... |
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) 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 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) Sources: Nausea (below serious, 2 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: |
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: 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 Sources: Page: p.1Dependence 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 (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) 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 (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
CYP3A4 | CYP2C9 | CYP2D6 | hERG |
---|---|---|---|
OverviewOther
Other Inhibitor | Other Substrate | Other Inducer |
---|---|---|
Drug as perpetrator
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
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: 21.0 |
no |
PubMed
Title | Date | PubMed |
---|---|---|
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 |
|
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 |
|
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 |
|
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 |
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
In Vitro Use Guide
Sources: https://www.ncbi.nlm.nih.gov/pubmed/17035599
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 | ||
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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
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||
|
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
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||
|
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
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||
|
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
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||
|
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 | ||
---|---|---|---|---|---|
|
11597698
Created by
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|
PRIMARY | |||
|
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 | |||
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C75114
Created by
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|
PRIMARY | |||
|
7213
Created by
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PRIMARY | |||
|
700810
Created by
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PRIMARY | RxNorm | ||
|
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
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PRIMARY | Merck Index | ||
|
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
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PRIMARY | |||
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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
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PRIMARY | |||
|
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
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PRIMARY | |||
|
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 | |||
|
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
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PRIMARY | |||
|
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
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PRIMARY | |||
|
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
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PRIMARY | |||
|
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
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PRIMARY | |||
|
H645GUL8KJ
Created by
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PRIMARY |
ACTIVE MOIETY
METABOLITE (PARENT)
METABOLITE (PARENT)
METABOLITE (PARENT)
METABOLITE (PARENT)
METABOLITE (PARENT)
METABOLITE (PARENT)
METABOLITE ACTIVE (PRODRUG)
SALT/SOLVATE (PARENT)