Details
Stereochemistry | ACHIRAL |
Molecular Formula | C10H15N |
Molecular Weight | 149.2328 |
Optical Activity | NONE |
Defined Stereocenters | 0 / 0 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
CC(C)(N)CC1=CC=CC=C1
InChI
InChIKey=DHHVAGZRUROJKS-UHFFFAOYSA-N
InChI=1S/C10H15N/c1-10(2,11)8-9-6-4-3-5-7-9/h3-7H,8,11H2,1-2H3
DescriptionSources: http://www.drugbank.ca/drugs/DB00191Curator's Comment: Description was created based on several sources, including https://www.drugs.com/dosage/phentermine.html
Sources: http://www.drugbank.ca/drugs/DB00191
Curator's Comment: Description was created based on several sources, including https://www.drugs.com/dosage/phentermine.html
Phentermine is an amphetamine that stimulates neurons to release or maintain high levels of a particular group of neurotransmitters known as catecholamines; these include dopamine and norepinephrine. High levels of these catecholamines tend to suppress hunger signals and appetite. The drug seems to inhibit reuptake of noradrenaline, dopamine, and seratonin through inhibition or reversal of the reuptake transporters. It may also inhibit MAO enzymes leaving more neurotransmitter available at the synapse. Phentermine (through catecholamine elevation) may also indirectly affect leptin levels in the brain. It is theorized that phentermine can raise levels of leptin which signal satiety. It is also theorized that increased levels of the catecholamines are partially responsible for halting another chemical messenger known as neuropeptide Y. This peptide initiates eating, decreases energy expenditure, and increases fat storage. Phentermine is indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction. Phentermine hydrochloride is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.
CNS Activity
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: CHEMBL238 Sources: http://www.drugbank.ca/drugs/DB00191 |
0.31 µM [EC50] | ||
Target ID: CHEMBL1951 Sources: https://www.ncbi.nlm.nih.gov/pubmed/11911838 |
498.0 µM [Ki] | ||
Target ID: CHEMBL2039 Sources: https://www.ncbi.nlm.nih.gov/pubmed/11911838 |
375.0 µM [Ki] | ||
Target ID: CHEMBL222 Sources: http://www.drugbank.ca/drugs/DB00191 |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Primary | ADIPEX-P Approved UseADIPEX-P® is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors Launch Date1958 |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
44.78 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/25668796 |
7.5 mg single, oral dose: 7.5 mg route of administration: Oral experiment type: SINGLE co-administered: TOPIRAMATE |
PHENTERMINE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
49.1 ng/mL |
15 mg single, oral dose: 15 mg route of administration: Oral experiment type: SINGLE co-administered: TOPIRAMATE |
PHENTERMINE plasma | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
AUC
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
2057.33 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/25668796 |
7.5 mg single, oral dose: 7.5 mg route of administration: Oral experiment type: SINGLE co-administered: TOPIRAMATE |
PHENTERMINE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
2000 ng × h/mL |
15 mg single, oral dose: 15 mg route of administration: Oral experiment type: SINGLE co-administered: TOPIRAMATE |
PHENTERMINE plasma | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
T1/2
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
20.63 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/25668796 |
7.5 mg single, oral dose: 7.5 mg route of administration: Oral experiment type: SINGLE co-administered: TOPIRAMATE |
PHENTERMINE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
20 h |
15 mg single, oral dose: 15 mg route of administration: Oral experiment type: SINGLE co-administered: TOPIRAMATE |
PHENTERMINE plasma | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
Funbound
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
82.5% |
15 mg single, oral dose: 15 mg route of administration: Oral experiment type: SINGLE co-administered: TOPIRAMATE |
PHENTERMINE plasma | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
Doses
Dose | Population | Adverse events |
---|---|---|
37.5 mg 1 times / day single, oral Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: single Dose: 37.5 mg, 1 times / day Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
healthy, 18 - 45 years old n = 17 Health Status: healthy Age Group: 18 - 45 years old Sex: M+F Population Size: 17 Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
Other AEs: Abdominal pain, Dizziness... Other AEs: Abdominal pain (6%) Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12Dizziness (6%) Early satiety (6%) Intermittent headache (6%) Nausea (6%) Swollen lips (6%) Upper respiratory infection (6%) |
37.5 mg 1 times / day single, oral Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: single Dose: 37.5 mg, 1 times / day Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
healthy, 18 - 45 years old n = 17 Health Status: healthy Age Group: 18 - 45 years old Sex: M+F Population Size: 17 Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
Other AEs: Anorexia, Back pain... Other AEs: Anorexia (6%) Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12Back pain (6%) Chapped lips (6%) Dry skin (6%) Dyspepsia (6%) Early satiety (6%) Irregular pulse (6%) Nausea (6%) |
390 mg 1 times / day single, oral Studied dose Dose: 390 mg, 1 times / day Route: oral Route: single Dose: 390 mg, 1 times / day Sources: |
healthy, mean age 30 years n = 2 Health Status: healthy Age Group: mean age 30 years Sex: M+F Population Size: 2 Sources: |
Other AEs: Tachycardia, Hypertension... Other AEs: Tachycardia Sources: Hypertension Visual disorders NEC Nausea Insomnia Anxiety |
15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Disc. AE: Amnesia, Judgement impaired... Other AEs: Disorder sleep, Depression... AEs leading to discontinuation/dose reduction: Amnesia (0.3%) Other AEs:Judgement impaired (0.3%) Memory impairment (0.3%) Paraesthesia (0.3%) Depression (1%) Anxiety (0.3%) Vision blurred (0.3%) Eye pain (0.3%) Abdominal pain (0.3%) Tuberculosis skin test positive (0.3%) Nephrolithiasis (0.3%) Disorder sleep (12.9%) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105Depression (8.1%) Anxiety (9.5%) Cardiac arrhythmia (4.1%) Ischemic heart disease (1%) Disturbance in attention (3.1%) Memory impairment (2%) Cognitive disorders (1.4%) Language disorder (0.3%) Ocular disorders NEC (4.1%) Dyskinesias and movement disorders NEC (1.4%) |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Abdominal pain | 6% | 37.5 mg 1 times / day single, oral Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: single Dose: 37.5 mg, 1 times / day Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
healthy, 18 - 45 years old n = 17 Health Status: healthy Age Group: 18 - 45 years old Sex: M+F Population Size: 17 Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
Dizziness | 6% | 37.5 mg 1 times / day single, oral Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: single Dose: 37.5 mg, 1 times / day Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
healthy, 18 - 45 years old n = 17 Health Status: healthy Age Group: 18 - 45 years old Sex: M+F Population Size: 17 Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
Early satiety | 6% | 37.5 mg 1 times / day single, oral Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: single Dose: 37.5 mg, 1 times / day Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
healthy, 18 - 45 years old n = 17 Health Status: healthy Age Group: 18 - 45 years old Sex: M+F Population Size: 17 Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
Intermittent headache | 6% | 37.5 mg 1 times / day single, oral Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: single Dose: 37.5 mg, 1 times / day Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
healthy, 18 - 45 years old n = 17 Health Status: healthy Age Group: 18 - 45 years old Sex: M+F Population Size: 17 Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
Nausea | 6% | 37.5 mg 1 times / day single, oral Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: single Dose: 37.5 mg, 1 times / day Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
healthy, 18 - 45 years old n = 17 Health Status: healthy Age Group: 18 - 45 years old Sex: M+F Population Size: 17 Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
Swollen lips | 6% | 37.5 mg 1 times / day single, oral Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: single Dose: 37.5 mg, 1 times / day Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
healthy, 18 - 45 years old n = 17 Health Status: healthy Age Group: 18 - 45 years old Sex: M+F Population Size: 17 Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
Upper respiratory infection | 6% | 37.5 mg 1 times / day single, oral Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: single Dose: 37.5 mg, 1 times / day Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
healthy, 18 - 45 years old n = 17 Health Status: healthy Age Group: 18 - 45 years old Sex: M+F Population Size: 17 Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
Anorexia | 6% | 37.5 mg 1 times / day single, oral Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: single Dose: 37.5 mg, 1 times / day Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
healthy, 18 - 45 years old n = 17 Health Status: healthy Age Group: 18 - 45 years old Sex: M+F Population Size: 17 Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
Back pain | 6% | 37.5 mg 1 times / day single, oral Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: single Dose: 37.5 mg, 1 times / day Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
healthy, 18 - 45 years old n = 17 Health Status: healthy Age Group: 18 - 45 years old Sex: M+F Population Size: 17 Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
Chapped lips | 6% | 37.5 mg 1 times / day single, oral Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: single Dose: 37.5 mg, 1 times / day Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
healthy, 18 - 45 years old n = 17 Health Status: healthy Age Group: 18 - 45 years old Sex: M+F Population Size: 17 Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
Dry skin | 6% | 37.5 mg 1 times / day single, oral Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: single Dose: 37.5 mg, 1 times / day Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
healthy, 18 - 45 years old n = 17 Health Status: healthy Age Group: 18 - 45 years old Sex: M+F Population Size: 17 Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
Dyspepsia | 6% | 37.5 mg 1 times / day single, oral Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: single Dose: 37.5 mg, 1 times / day Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
healthy, 18 - 45 years old n = 17 Health Status: healthy Age Group: 18 - 45 years old Sex: M+F Population Size: 17 Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
Early satiety | 6% | 37.5 mg 1 times / day single, oral Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: single Dose: 37.5 mg, 1 times / day Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
healthy, 18 - 45 years old n = 17 Health Status: healthy Age Group: 18 - 45 years old Sex: M+F Population Size: 17 Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
Irregular pulse | 6% | 37.5 mg 1 times / day single, oral Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: single Dose: 37.5 mg, 1 times / day Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
healthy, 18 - 45 years old n = 17 Health Status: healthy Age Group: 18 - 45 years old Sex: M+F Population Size: 17 Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
Nausea | 6% | 37.5 mg 1 times / day single, oral Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: single Dose: 37.5 mg, 1 times / day Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
healthy, 18 - 45 years old n = 17 Health Status: healthy Age Group: 18 - 45 years old Sex: M+F Population Size: 17 Sources: Page: nda/2012/202088Orig2s000MedR.pdf - p.12 |
Anxiety | 390 mg 1 times / day single, oral Studied dose Dose: 390 mg, 1 times / day Route: oral Route: single Dose: 390 mg, 1 times / day Sources: |
healthy, mean age 30 years n = 2 Health Status: healthy Age Group: mean age 30 years Sex: M+F Population Size: 2 Sources: |
|
Hypertension | 390 mg 1 times / day single, oral Studied dose Dose: 390 mg, 1 times / day Route: oral Route: single Dose: 390 mg, 1 times / day Sources: |
healthy, mean age 30 years n = 2 Health Status: healthy Age Group: mean age 30 years Sex: M+F Population Size: 2 Sources: |
|
Insomnia | 390 mg 1 times / day single, oral Studied dose Dose: 390 mg, 1 times / day Route: oral Route: single Dose: 390 mg, 1 times / day Sources: |
healthy, mean age 30 years n = 2 Health Status: healthy Age Group: mean age 30 years Sex: M+F Population Size: 2 Sources: |
|
Nausea | 390 mg 1 times / day single, oral Studied dose Dose: 390 mg, 1 times / day Route: oral Route: single Dose: 390 mg, 1 times / day Sources: |
healthy, mean age 30 years n = 2 Health Status: healthy Age Group: mean age 30 years Sex: M+F Population Size: 2 Sources: |
|
Tachycardia | 390 mg 1 times / day single, oral Studied dose Dose: 390 mg, 1 times / day Route: oral Route: single Dose: 390 mg, 1 times / day Sources: |
healthy, mean age 30 years n = 2 Health Status: healthy Age Group: mean age 30 years Sex: M+F Population Size: 2 Sources: |
|
Visual disorders NEC | 390 mg 1 times / day single, oral Studied dose Dose: 390 mg, 1 times / day Route: oral Route: single Dose: 390 mg, 1 times / day Sources: |
healthy, mean age 30 years n = 2 Health Status: healthy Age Group: mean age 30 years Sex: M+F Population Size: 2 Sources: |
|
Language disorder | 0.3% | 15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Abdominal pain | 0.3% Disc. AE |
15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Amnesia | 0.3% Disc. AE |
15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Anxiety | 0.3% Disc. AE |
15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Eye pain | 0.3% Disc. AE |
15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Judgement impaired | 0.3% Disc. AE |
15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Memory impairment | 0.3% Disc. AE |
15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Nephrolithiasis | 0.3% Disc. AE |
15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Paraesthesia | 0.3% Disc. AE |
15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Tuberculosis skin test positive | 0.3% Disc. AE |
15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Vision blurred | 0.3% Disc. AE |
15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Ischemic heart disease | 1% | 15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Depression | 1% Disc. AE |
15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Cognitive disorders | 1.4% | 15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Dyskinesias and movement disorders NEC | 1.4% | 15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Disorder sleep | 12.9% | 15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Memory impairment | 2% | 15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Disturbance in attention | 3.1% | 15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Cardiac arrhythmia | 4.1% | 15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Ocular disorders NEC | 4.1% | 15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Depression | 8.1% | 15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Anxiety | 9.5% | 15 mg 1 times / day multiple, oral Recommended Dose: 15 mg, 1 times / day Route: oral Route: multiple Dose: 15 mg, 1 times / day Co-administed with:: topiramate(92 mg; 1/day) Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
unhealthy, mean age 51.9 years n = 295 Health Status: unhealthy Condition: obesity Age Group: mean age 51.9 years Sex: M+F Population Size: 295 Sources: Page: nda/2012/022580Orig1s000MedR.pdf - p.105 |
Overview
CYP3A4 | CYP2C9 | CYP2D6 | hERG |
---|---|---|---|
OverviewOther
Other Inhibitor | Other Substrate | Other Inducer |
---|---|---|
Drug as perpetrator
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022580Orig1s000ClinPharmR.pdf#page=17 Page: 17.0 |
no | |||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022580Orig1s000ClinPharmR.pdf#page=39 Page: 39.0 |
no | |||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022580Orig1s000ClinPharmR.pdf#page=39 Page: 39.0 |
no | |||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022580Orig1s000ClinPharmR.pdf#page=39 Page: 39.0 |
no | |||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022580Orig1s000ClinPharmR.pdf#page=39 Page: 39.0 |
no | |||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022580Orig1s000ClinPharmR.pdf#page=39 Page: 39.0 |
no |
Drug as victim
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022580Orig1s000ClinPharmR.pdf#page=39 Page: 39,38 |
major | weak (co-administration study) Comment: In the presence of topiramate, phentermine Cmax and AUC0-inf increased 13 and 42%, respectively Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022580Orig1s000ClinPharmR.pdf#page=39 Page: 39,38 |
PubMed
Title | Date | PubMed |
---|---|---|
[Valvular heart disease and primary pulmonary hypertension associated with fenfluramine-phentermine]. | 1998 Dec 1 |
|
Echocardiographic improvement over time after cessation of use of fenfluramine and phentermine. | 1999 Dec |
|
Echocardiographic prevalence of mitral and/or aortic regurgitation in patients exposed to either fenfluramine-phentermine combination or to dexfenfluramine. | 1999 Dec 1 |
|
Valve replacement for appetite suppressant-induced valvular heart disease. | 1999 Jun |
|
Pharmaceutical cost savings of treating obesity with weight loss medications. | 1999 Nov |
|
Histologic changes in three explanted native cardiac valves following use of fenfluramines. | 1999 Sep-Oct |
|
Dose and duration of fenfluramine-phentermine therapy impacts the risk of significant valvular heart disease. | 2000 Jul 1 |
|
Complex vascular lesions at autopsy in a patient with phentermine-fenfluramin. | 2000 Jun |
|
A concise review on the therapeutics of obesity. | 2000 Oct |
|
Pharmacologic options for the treatment of obesity. | 2001 Jul 15 |
|
Monoamine oxidase inhibition is unlikely to be relevant to the risks associated with phentermine and fenfluramine: a comparison with their abilities to evoke monoamine release. | 2001 Oct |
|
Additive effects on rat brain 5HT release of combining phentermine with dexfenfluramine. | 2001 Oct |
|
Pharmacotherapy of obesity: currently marketed and upcoming agents. | 2002 |
|
Fen-Phen-noumenon: A mass tort litigation and settlement about to come and go. | 2002 Aug |
|
[Syncope - a systematic overview of classification, pathogenesis, diagnosis and management]. | 2002 Feb |
|
Automated headspace solid-phase microextraction and in-matrix derivatization for the determination of amphetamine-related drugs in human urine by gas chromatography-mass spectrometry. | 2002 Jan |
|
Inhibition of cocaine self-administration by fluoxetine or D-fenfluramine combined with phentermine. | 2002 Jan-Feb |
|
Reversal of Phen-Fen associated valvular regurgitation documented by serial echocardiography. | 2002 Jun |
|
Cocaine withdrawal severity and urine toxicology results from treatment entry predict outcome in medication trials for cocaine dependence. | 2002 Mar-Apr |
|
Effects of preexposure to dexfenfluramine, phentermine, dexfenfluramine-phentermine, or fluoxetine on sibutramine-induced hypophagia in the adult rat. | 2003 Apr |
|
Anorexigen-induced cardiac valvulopathy and female gender. | 2003 Apr |
|
Effects of tyrosine, phentermine, caffeine D-amphetamine, and placebo on cognitive and motor performance deficits during sleep deprivation. | 2003 Aug |
|
A comparison of tyrosine against placebo, phentermine, caffeine, and D-amphetamine during sleep deprivation. | 2003 Aug |
|
Obesity. | 2003 Dec |
|
Do these doctors give medicine a black eye? | 2003 Dec |
|
Ischemic colitis after weight-loss medication. | 2003 Dec |
|
The effect of the anorectic agent, d-fenfluramine, and its primary metabolite, d-norfenfluramine, on intact human platelet serotonin uptake and efflux. | 2003 Dec |
|
Internet pharmacy prescription and phentermine overdose. | 2003 Feb |
|
Treatment of obesity: an update on anti-obesity medications. | 2003 Feb |
|
Medical monitoring for pharmaceutical injuries: tort law for the public's health? | 2003 Feb 19 |
|
Liquid chromatography studies on the pharmacokinetics of phentermine and fenfluramine in brain and blood microdialysates after intraperitoneal administration to rats. | 2003 Jul 5 |
|
Risk of valvular heart disease associated with use of fenfluramine. | 2003 Jun 11 |
|
Postmarketing surveillance of abuse liability of sibutramine. | 2003 Mar 1 |
|
National trends in antiobesity medication use. | 2003 May 12 |
|
Malpractice. Conviction upheld for doctor who treated AIDS with fen/phen. | 2003 May 9 |
|
Obesity: an overview on its current perspectives and treatment options. | 2004 Apr 14 |
|
The "steroid dementia syndrome": an unrecognized complication of glucocorticoid treatment. | 2004 Dec |
|
Beneficial effects of weight loss on plasma apolipoproteins in postmenopausal women. | 2004 Dec |
|
Going before disciplinary board without counsel is unwise. Case on point: Slone-Vasquez v. Kentucky Board Of Nursing, 2003 WL 22976179 S.W.3d-KY. | 2004 Jan |
|
Pharmacological and surgical treatment of obesity. | 2004 Jul |
|
Relationship between collagen fibrils, glycosaminoglycans, and stress relaxation in mitral valve chordae tendineae. | 2004 Jul |
|
Taking things to heart. | 2004 Jul |
|
Obesity. | 2004 Jun |
|
The long-term management of obesity with continuing pharmacotherapy. | 2004 Nov |
|
Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus. | 2005 Jan 25 |
|
Effects of phentermine and phenformin on biomarkers of aging in rats. | 2005 Jan-Feb |
|
Acute nonarteritic ischaemic optic neuropathy after phentermine. | 2005 Nov |
Sample Use Guides
In Vivo Use Guide
Sources: https://www.drugs.com/dosage/phentermine.html
Usual Adult Dose for Weight Loss
15 to 37.5 mg orally once a day before breakfast or 1 to 2 hours after breakfast.
Usual Pediatric Dose for Weight Loss
17 years or older:
15 to 37.5 mg orally once a day before breakfast or 1 to 2 hours after breakfast.
Route of Administration:
Oral
In Vitro Use Guide
Sources: https://www.ncbi.nlm.nih.gov/pubmed/10799660
Phentermine inhibited serotonin-metabolizing (MAO-A) activity in rat lung, brain, and liver with K(i) values of 85-88 uM.
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NBK548947
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ACTIVE MOIETY
SALT/SOLVATE (PARENT)