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

Details

Stereochemistry ACHIRAL
Molecular Formula C15H12N2O2
Molecular Weight 252.268
Optical Activity NONE
Defined Stereocenters 0 / 0
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of OXCARBAZEPINE

SMILES

NC(=O)N1C2=C(CC(=O)C3=C1C=CC=C3)C=CC=C2

InChI

InChIKey=CTRLABGOLIVAIY-UHFFFAOYSA-N
InChI=1S/C15H12N2O2/c16-15(19)17-12-7-3-1-5-10(12)9-14(18)11-6-2-4-8-13(11)17/h1-8H,9H2,(H2,16,19)

HIDE SMILES / InChI
Molecular Formula C15H12N2O2
Molecular Weight 252.268
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Description
Curator's Comment: Description was created based on several sources, including https://www.ncbi.nlm.nih.gov/pubmed/11394728

Oxcarbazepine and its active metabolite (10,11-dihydro-10-hydroxy-carbazepine, MHD) have been effective in animal models of epilepsy that generally predict efficacy in generalized tonic-clonic seizures and partial seizures in humans. The pharmacokinetic profile of oxcarbazepine is less complicated than that of carbamazepine, with less metabolism by the cytochrome P450 system, no production of an epoxide metabolite, and lower plasma protein binding. The clinical efficacy and tolerability of oxcarbazepine have been demonstrated in trials in adults, children, and the elderly. The pharmacological activity of oxcarbazepine is primarily exerted through the 10-monohydroxy metabolite (MHD) of oxcarbazepine. The precise mechanism by which oxcarbazepine and MHD exert their antiseizure effect is unknown; however, in vitro electrophysiological studies indicate that they produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. These actions are thought to be important in the prevention of seizure spread in the intact brain. In addition, increased potassium conductance and modulation of high-voltage activated calcium channels may contribute to the anticonvulsant effects of the drug.

CNS Activity

Originator

Approval Year

2000
171
Targets

Targets

Primary TargetPharmacologyConditionPotency
Inhibitor
8297
Blocker
537
 50.0 nM [IC50]
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Phase III
656
Unknown

Approved Use

Unknown
Primary
Approved
8429
TRILEPTAL

Approved Use

Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in children aged 4 years and above with epilepsy, and as adjunctive therapy in children aged 2 years and above with partial seizures. Oxcarbazepine tablet is an antiepileptic drug indicated for: Adults: -Monotherapy or adjunctive therapy in the treatment of partial seizures Children: -Monotherapy in the treatment of partial seizures in children 4-16 years -Adjunctive therapy in the treatment of partial seizures in children 2-16 years (1)

Launch Date

2000
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
1.55 μg/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/26514967
300 mg 2 times / day multiple, oral
dose: 300 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
OXCARBAZEPINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
7119 ng/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT00850174
600 mg single, oral
dose: 600 mg
route of administration: oral
experiment type: single
co-administered:
LICARBAZEPINE plasma
Homo sapiens
population:
age:
sex:
food status: Fasted
9349.83 ng/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT00849797
600 mg single, oral
dose: 600 mg
route of administration: oral
experiment type: single
co-administered:
LICARBAZEPINE plasma
Homo sapiens
population:
age:
sex:
food status: Fed
1630.3 ng/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT00850174
600 mg single, oral
dose: 600 mg
route of administration: oral
experiment type: single
co-administered:
OXCARBAZEPINE plasma
Homo sapiens
population:
age:
sex:
food status: Fasted
3537.63 ng/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT00849797
600 mg single, oral
dose: 600 mg
route of administration: oral
experiment type: single
co-administered:
OXCARBAZEPINE plasma
Homo sapiens
population:
age:
sex:
food status: Fed
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
3.76 μg × h/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/26514967
300 mg 2 times / day multiple, oral
dose: 300 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
OXCARBAZEPINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
157372 ng*h/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT00850174
600 mg single, oral
dose: 600 mg
route of administration: oral
experiment type: single
co-administered:
LICARBAZEPINE plasma
Homo sapiens
population:
age:
sex:
food status: Fasted
179002.4 ng*h/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT00849797
600 mg single, oral
dose: 600 mg
route of administration: oral
experiment type: single
co-administered:
LICARBAZEPINE plasma
Homo sapiens
population:
age:
sex:
food status: Fed
173770 ng*h/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT00850174
600 mg single, oral
dose: 600 mg
route of administration: oral
experiment type: single
co-administered:
LICARBAZEPINE plasma
Homo sapiens
population:
age:
sex:
food status: Fasted
197864.34 ng*h/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT00849797
600 mg single, oral
dose: 600 mg
route of administration: oral
experiment type: single
co-administered:
LICARBAZEPINE plasma
Homo sapiens
population:
age:
sex:
food status: Fed
5309.5 ng*h/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT00850174
600 mg single, oral
dose: 600 mg
route of administration: oral
experiment type: single
co-administered:
OXCARBAZEPINE plasma
Homo sapiens
population:
age:
sex:
food status: Fasted
9445.55 ng*h/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT00849797
600 mg single, oral
dose: 600 mg
route of administration: oral
experiment type: single
co-administered:
OXCARBAZEPINE plasma
Homo sapiens
population:
age:
sex:
food status: Fed
5873.1 ng*h/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT00850174
600 mg single, oral
dose: 600 mg
route of administration: oral
experiment type: single
co-administered:
OXCARBAZEPINE plasma
Homo sapiens
population:
age:
sex:
food status: Fasted
9679.79 ng*h/mL
Clinical Trial
https://clinicaltrials.gov/ct2/show/NCT00849797
600 mg single, oral
dose: 600 mg
route of administration: oral
experiment type: single
co-administered:
OXCARBAZEPINE plasma
Homo sapiens
population:
age:
sex:
food status: Fed
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
2.38 h
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/26514967
300 mg 2 times / day multiple, oral
dose: 300 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
OXCARBAZEPINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
27%
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/26514967
300 mg 2 times / day multiple, oral
dose: 300 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
OXCARBAZEPINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
Doses

Doses

DosePopulationAdverse events​
8 mg/kg 1 times / day steady, oral (starting)
Recommended
Dose: 8 mg/kg, 1 times / day
Route: oral
Route: steady
Dose: 8 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, 1 month -4 years
n = 241
Health Status: unhealthy
Condition: partial seizures
Age Group: 1 month -4 years
Population Size: 241
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Disc. AE: Convulsions, Status epilepticus...
AEs leading to
discontinuation/dose reduction:
Convulsions (3.7%)
Status epilepticus (1.2%)
Ataxia (1.2%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
15 g single, oral
Overdose
Dose: 15 g
Route: oral
Route: single
Dose: 15 g
Sources:
https://pubmed.ncbi.nlm.nih.gov/19552755
unhealthy, 13 years
n = 1
Health Status: unhealthy
Age Group: 13 years
Sex: M
Population Size: 1
Sources:
https://pubmed.ncbi.nlm.nih.gov/19552755
Other AEs: Vomiting...
Other AEs:
Vomiting (1 patient)
Sources:
https://pubmed.ncbi.nlm.nih.gov/19552755
2700 mg 1 times / day multiple, oral
Highest studied dose
Dose: 2700 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2700 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/22850688
unhealthy, 19-70 years
n = 71
Health Status: unhealthy
Age Group: 19-70 years
Sex: M+F
Population Size: 71
Sources:
https://pubmed.ncbi.nlm.nih.gov/22850688
Other AEs: Dizziness, Tremor...
Other AEs:
Dizziness
Tremor
Somnolence
Headache
Sources:
https://pubmed.ncbi.nlm.nih.gov/22850688
30600 mg single, oral
Overdose
Dose: 30600 mg
Route: oral
Route: single
Dose: 30600 mg
Sources:
https://pubmed.ncbi.nlm.nih.gov/15327594
unhealthy, 36 years
n = 1
Health Status: unhealthy
Age Group: 36 years
Sex: M
Population Size: 1
Sources:
https://pubmed.ncbi.nlm.nih.gov/15327594
Sources:
https://pubmed.ncbi.nlm.nih.gov/15327594
8 mg/kg 1 times / day steady, oral (starting)
Recommended
Dose: 8 mg/kg, 1 times / day
Route: oral
Route: steady
Dose: 8 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, 4-16 years
n = 456
Health Status: unhealthy
Condition: partial seizures
Age Group: 4-16 years
Population Size: 456
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Disc. AE: Somnolence, Vomiting...
AEs leading to
discontinuation/dose reduction:
Somnolence (2.4%)
Vomiting (2%)
Ataxia (1.8%)
Diplopia (1.3%)
Dizziness (1.3%)
Fatigue (1.1%)
Nystagmus (1.1%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
12 mg/kg 1 times / day steady, oral (starting)
Dose: 12 mg/kg, 1 times / day
Route: oral
Route: steady
Dose: 12 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/28580160
unhealthy, 6 years
n = 1
Health Status: unhealthy
Condition: f benign rolandic epilepsy
Age Group: 6 years
Sex: M
Population Size: 1
Sources:
https://pubmed.ncbi.nlm.nih.gov/28580160
Disc. AE: Stevens Johnson syndrome...
AEs leading to
discontinuation/dose reduction:
Stevens Johnson syndrome (1 patient)
Sources:
https://pubmed.ncbi.nlm.nih.gov/28580160
300 mg 2 times / day steady, oral (starting)
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, adult
n = 1524
Health Status: unhealthy
Condition: epilepsy
Age Group: adult
Population Size: 1524
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Disc. AE: Hyponatremia...
AEs leading to
discontinuation/dose reduction:
Hyponatremia (2.5%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
300 mg 2 times / day steady, oral (starting)
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, adult
n = 1537
Health Status: unhealthy
Condition: partial seizures
Age Group: adult
Population Size: 1537
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Disc. AE: Dizziness, Diplopia...
AEs leading to
discontinuation/dose reduction:
Dizziness (6.4%)
Diplopia (5.9%)
Ataxia (5.2%)
Vomiting (5.1%)
Nausea (4.9%)
Somnolence (3.8%)
Headache (2.9%)
Fatigue (2.1%)
Abnormal vision (2.1%)
Tremor (1.8%)
Abnormal gait (1.7%)
Rash (1.4%)
Hyponatremia (1%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
AEs

AEs

AESignificanceDosePopulation
Ataxia 1.2%
Disc. AE
8 mg/kg 1 times / day steady, oral (starting)
Recommended
Dose: 8 mg/kg, 1 times / day
Route: oral
Route: steady
Dose: 8 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, 1 month -4 years
n = 241
Health Status: unhealthy
Condition: partial seizures
Age Group: 1 month -4 years
Population Size: 241
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Status epilepticus 1.2%
Disc. AE
8 mg/kg 1 times / day steady, oral (starting)
Recommended
Dose: 8 mg/kg, 1 times / day
Route: oral
Route: steady
Dose: 8 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, 1 month -4 years
n = 241
Health Status: unhealthy
Condition: partial seizures
Age Group: 1 month -4 years
Population Size: 241
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Convulsions 3.7%
Disc. AE
8 mg/kg 1 times / day steady, oral (starting)
Recommended
Dose: 8 mg/kg, 1 times / day
Route: oral
Route: steady
Dose: 8 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, 1 month -4 years
n = 241
Health Status: unhealthy
Condition: partial seizures
Age Group: 1 month -4 years
Population Size: 241
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Vomiting 1 patient
15 g single, oral
Overdose
Dose: 15 g
Route: oral
Route: single
Dose: 15 g
Sources:
https://pubmed.ncbi.nlm.nih.gov/19552755
unhealthy, 13 years
n = 1
Health Status: unhealthy
Age Group: 13 years
Sex: M
Population Size: 1
Sources:
https://pubmed.ncbi.nlm.nih.gov/19552755
Dizziness
2700 mg 1 times / day multiple, oral
Highest studied dose
Dose: 2700 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2700 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/22850688
unhealthy, 19-70 years
n = 71
Health Status: unhealthy
Age Group: 19-70 years
Sex: M+F
Population Size: 71
Sources:
https://pubmed.ncbi.nlm.nih.gov/22850688
Headache
2700 mg 1 times / day multiple, oral
Highest studied dose
Dose: 2700 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2700 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/22850688
unhealthy, 19-70 years
n = 71
Health Status: unhealthy
Age Group: 19-70 years
Sex: M+F
Population Size: 71
Sources:
https://pubmed.ncbi.nlm.nih.gov/22850688
Somnolence
2700 mg 1 times / day multiple, oral
Highest studied dose
Dose: 2700 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2700 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/22850688
unhealthy, 19-70 years
n = 71
Health Status: unhealthy
Age Group: 19-70 years
Sex: M+F
Population Size: 71
Sources:
https://pubmed.ncbi.nlm.nih.gov/22850688
Tremor
2700 mg 1 times / day multiple, oral
Highest studied dose
Dose: 2700 mg, 1 times / day
Route: oral
Route: multiple
Dose: 2700 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/22850688
unhealthy, 19-70 years
n = 71
Health Status: unhealthy
Age Group: 19-70 years
Sex: M+F
Population Size: 71
Sources:
https://pubmed.ncbi.nlm.nih.gov/22850688
Fatigue 1.1%
Disc. AE
8 mg/kg 1 times / day steady, oral (starting)
Recommended
Dose: 8 mg/kg, 1 times / day
Route: oral
Route: steady
Dose: 8 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, 4-16 years
n = 456
Health Status: unhealthy
Condition: partial seizures
Age Group: 4-16 years
Population Size: 456
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Nystagmus 1.1%
Disc. AE
8 mg/kg 1 times / day steady, oral (starting)
Recommended
Dose: 8 mg/kg, 1 times / day
Route: oral
Route: steady
Dose: 8 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, 4-16 years
n = 456
Health Status: unhealthy
Condition: partial seizures
Age Group: 4-16 years
Population Size: 456
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Diplopia 1.3%
Disc. AE
8 mg/kg 1 times / day steady, oral (starting)
Recommended
Dose: 8 mg/kg, 1 times / day
Route: oral
Route: steady
Dose: 8 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, 4-16 years
n = 456
Health Status: unhealthy
Condition: partial seizures
Age Group: 4-16 years
Population Size: 456
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Dizziness 1.3%
Disc. AE
8 mg/kg 1 times / day steady, oral (starting)
Recommended
Dose: 8 mg/kg, 1 times / day
Route: oral
Route: steady
Dose: 8 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, 4-16 years
n = 456
Health Status: unhealthy
Condition: partial seizures
Age Group: 4-16 years
Population Size: 456
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Ataxia 1.8%
Disc. AE
8 mg/kg 1 times / day steady, oral (starting)
Recommended
Dose: 8 mg/kg, 1 times / day
Route: oral
Route: steady
Dose: 8 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, 4-16 years
n = 456
Health Status: unhealthy
Condition: partial seizures
Age Group: 4-16 years
Population Size: 456
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Vomiting 2%
Disc. AE
8 mg/kg 1 times / day steady, oral (starting)
Recommended
Dose: 8 mg/kg, 1 times / day
Route: oral
Route: steady
Dose: 8 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, 4-16 years
n = 456
Health Status: unhealthy
Condition: partial seizures
Age Group: 4-16 years
Population Size: 456
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Somnolence 2.4%
Disc. AE
8 mg/kg 1 times / day steady, oral (starting)
Recommended
Dose: 8 mg/kg, 1 times / day
Route: oral
Route: steady
Dose: 8 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, 4-16 years
n = 456
Health Status: unhealthy
Condition: partial seizures
Age Group: 4-16 years
Population Size: 456
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Stevens Johnson syndrome 1 patient
Disc. AE
12 mg/kg 1 times / day steady, oral (starting)
Dose: 12 mg/kg, 1 times / day
Route: oral
Route: steady
Dose: 12 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/28580160
unhealthy, 6 years
n = 1
Health Status: unhealthy
Condition: f benign rolandic epilepsy
Age Group: 6 years
Sex: M
Population Size: 1
Sources:
https://pubmed.ncbi.nlm.nih.gov/28580160
Hyponatremia 2.5%
Disc. AE
300 mg 2 times / day steady, oral (starting)
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, adult
n = 1524
Health Status: unhealthy
Condition: epilepsy
Age Group: adult
Population Size: 1524
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Hyponatremia 1%
Disc. AE
300 mg 2 times / day steady, oral (starting)
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, adult
n = 1537
Health Status: unhealthy
Condition: partial seizures
Age Group: adult
Population Size: 1537
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Rash 1.4%
Disc. AE
300 mg 2 times / day steady, oral (starting)
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, adult
n = 1537
Health Status: unhealthy
Condition: partial seizures
Age Group: adult
Population Size: 1537
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Abnormal gait 1.7%
Disc. AE
300 mg 2 times / day steady, oral (starting)
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, adult
n = 1537
Health Status: unhealthy
Condition: partial seizures
Age Group: adult
Population Size: 1537
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Tremor 1.8%
Disc. AE
300 mg 2 times / day steady, oral (starting)
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, adult
n = 1537
Health Status: unhealthy
Condition: partial seizures
Age Group: adult
Population Size: 1537
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Abnormal vision 2.1%
Disc. AE
300 mg 2 times / day steady, oral (starting)
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, adult
n = 1537
Health Status: unhealthy
Condition: partial seizures
Age Group: adult
Population Size: 1537
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Fatigue 2.1%
Disc. AE
300 mg 2 times / day steady, oral (starting)
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, adult
n = 1537
Health Status: unhealthy
Condition: partial seizures
Age Group: adult
Population Size: 1537
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Headache 2.9%
Disc. AE
300 mg 2 times / day steady, oral (starting)
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, adult
n = 1537
Health Status: unhealthy
Condition: partial seizures
Age Group: adult
Population Size: 1537
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Somnolence 3.8%
Disc. AE
300 mg 2 times / day steady, oral (starting)
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, adult
n = 1537
Health Status: unhealthy
Condition: partial seizures
Age Group: adult
Population Size: 1537
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Nausea 4.9%
Disc. AE
300 mg 2 times / day steady, oral (starting)
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, adult
n = 1537
Health Status: unhealthy
Condition: partial seizures
Age Group: adult
Population Size: 1537
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Vomiting 5.1%
Disc. AE
300 mg 2 times / day steady, oral (starting)
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, adult
n = 1537
Health Status: unhealthy
Condition: partial seizures
Age Group: adult
Population Size: 1537
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Ataxia 5.2%
Disc. AE
300 mg 2 times / day steady, oral (starting)
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, adult
n = 1537
Health Status: unhealthy
Condition: partial seizures
Age Group: adult
Population Size: 1537
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Diplopia 5.9%
Disc. AE
300 mg 2 times / day steady, oral (starting)
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, adult
n = 1537
Health Status: unhealthy
Condition: partial seizures
Age Group: adult
Population Size: 1537
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Dizziness 6.4%
Disc. AE
300 mg 2 times / day steady, oral (starting)
Recommended
Dose: 300 mg, 2 times / day
Route: oral
Route: steady
Dose: 300 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
unhealthy, adult
n = 1537
Health Status: unhealthy
Condition: partial seizures
Age Group: adult
Population Size: 1537
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
inhibitor
1767
inhibitor
1852

OverviewOther

Other InhibitorOther SubstrateOther Inducer
MRP3
157

MRP4
204

CYP1A2
1524

CYP2A6
707

CYP2E1
882

CYP3A4/5
278

CYP4A9/11
37

CYP2C19
1478

OATP1B1
788

OATP1B3
706

BSEP
402

MRP2
383

ALDH1
40
AKR1C1
19

AKR1C2
9

AKR1C3
13

AKR1C4
6

P-gp
1537

UGT1A9
380

UGT2B7
389

UGT1A4
347
CYP3A4/5
124

UGT
29
Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
ALDH1
40
 inconclusive [Activation 39.8107 uM]
UGT
59
 likely
BSEP
403
 no [IC50 >133 uM]
MRP2
475
 no [IC50 >133 uM]
MRP3
207
 no [IC50 >133 uM]
MRP4
238
 no [IC50 >133 uM]
CYP1A2
1692
 no [Ki 1150 uM]
CYP1A2
1692
 no [Ki >1350 uM]
MHD
2
CYP2A6
739
 no [Ki >1350 uM]
CYP2A6
739
 no [Ki >1350 uM]
MHD
2
CYP2C9
1819
 no [Ki >1350 uM]
CYP2C9
1819
 no [Ki >1350 uM]
MHD
2
CYP4A9/11
37
 no [Ki >1350 uM]
CYP4A9/11
37
 no [Ki >1350 uM]
MHD
2
CYP2D6
1891
 no [Ki >1800 uM]
CYP2D6
1891
 no [Ki >1800 uM]
MHD
2
CYP2E1
970
 no [Ki >900 uM]
CYP2E1
970
 no [Ki >900 uM]
MHD
2
CYP3A4/5
335
 weak [Ki 270 uM]
CYP3A4/5
335
 weak [Ki 647 uM]
MHD
2
UGT
59
 weak
MHD
2
CYP2C19
1553
 yes [Ki 228 uM]
CYP2C19
1553
 yes [Ki 88 uM]
MHD
2
CYP3A4/5
335
 yes
MHD
2
OATP1B1
803
 yes
OATP1B3
715
 yes
CYP3A4/5
335
 yes
yes (co-administration study)
Comment: Coadministration of OXCARBAZEPINE decreased the AUC for Felodipine and Ethinylestradiol (both CYP3A4 substrate)
Page: (Pharm) 19, (Label) 18
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
UGT1A9
380
 major
MHD
2
UGT2B7
389
 major
MHD
2
UGT1A4
347
 minor
MHD
2
AKR1C1
19
 yes [Km 24.3 uM]
AKR1C4
6
 yes [Km 2583 uM]
AKR1C2
9
 yes [Km 59 uM]
AKR1C3
13
 yes [Km 90 uM]
P-gp
1537
 yes
yes (co-administration study)
Comment: Co-administration of verapamil (P-gp inhibitor) resulted in a modest increase of the apparent bioavailability of oxcarbazepine by 12% (10-28), but did not affect parent or metabolite clearances.
Sourcing

Sourcing

Vendor/AggregatorIDURL
ChEBI
CHEBI:7824
https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:7824
ChemicalBook
CB9238172
https://www.chemicalbook.com/ChemicalProductProperty_EN_CB9238172
MolPort
MolPort-001-685-316
https://www.molport.com/shop/molecule-link/MolPort-001-685-316
Selleck Chemicals
Oxcarbazepine
http://www.selleckchem.com/products/Oxcarbazepine.html
ZINC
ZINC000000004724
http://zinc15.docking.org/substances/ZINC000000004724
eMolecules
592941
https://www.emolecules.com/cgi-bin/more?vid=592941
PubMed

PubMed

TitleDatePubMed
Elimination of oxcarbazepine-induced oculogyric crisis following vagus nerve stimulation.
1999 Jun 10
[New antiepileptic drugs in childhood epilepsies: indications and limits].
2001
Effect of oxcarbazepine on kainic acid-induced seizure.
2001
Is it Crohn's disease? A severe systemic granulomatous reaction to sulfasalazine in patient with rheumatoid arthritis.
2001
Behavioural effects of the new anticonvulsants.
2001
Newer antiepileptic drugs: advantages and disadvantages.
2001 Aug
[Ad hoc change from carbamazepine to oxcarbazepine--effectiveness and tolerance. A retrospective analysis].
2001 Dec
Progress report on new antiepileptic drugs: a summary of the Fifth Eilat Conference (EILAT V).
2001 Jan
Suppressive effects of oxcarbazepine on tooth pulp-evoked potentials recorded at the trigeminal spinal tract nucleus in cats.
2001 Mar
Oxcarbazepine, an antiepileptic agent.
2001 May
Metabolism of two new antiepileptic drugs and their principal metabolites S(+)- and R(-)-10,11-dihydro-10-hydroxy carbamazepine.
2001 May
Inhibition of glutamate release by BIA 2-093 and BIA 2-024, two novel derivatives of carbamazepine, due to blockade of sodium but not calcium channels.
2001 May 15
Symptomatic trigeminal-autonomic cephalalgia evolving to trigeminal neuralgia: report of a case associated with dual pathology.
2001 Nov
Transplacental passage of oxcarbazepine and its metabolites in vivo.
2001 Nov
Plasma concentration of topiramate correlates with cerebrospinal fluid concentration.
2001 Oct
Open pilot study on oxcarbazepine for the treatment of notalgia paresthetica.
2001 Oct
Oxcarbazepine in bipolar disorder.
2001 Sep
Hyponatremia and leukopenia associated with oxcarbazepine following carbamazepine therapy.
2001 Sep 1
Oxcarbazepine (Trileptal) as monotherapy in patients with partial seizures.
2001 Sep 11
Clinical pharmacodynamics and pharmacokinetics of antimanic and mood-stabilizing medications.
2002
The 'number needed to treat' with levetiracetam (LEV): comparison with the other new antiepileptic drugs (AEDs).
2002 Apr
Gabapentin: new indication. Little impact on partial epilepsy in children between 3 and 12.
2002 Apr
Mechanisms of action of carbamazepine and its derivatives, oxcarbazepine, BIA 2-093, and BIA 2-024.
2002 Feb
Simultaneous determination of four antiepileptic drugs in serum by high-performance liquid chromatography.
2002 Feb
Oxcarbazepine for epilepsy--a useful new choice?
2002 Jun
Effects of oxcarbazepine on sodium concentration and water handling.
2002 May
Progress report on new antiepileptic drugs: a summary of the Sixth Eilat Conference (EILAT VI).
2002 Sep
A pilot study on brain-to-plasma partition of 10,11-dyhydro-10-hydroxy-5H-dibenzo(b,f)azepine-5-carboxamide and MDR1 brain expression in epilepsy patients not responding to oxcarbazepine.
2005 Oct
Stereoselective disposition of S- and R-licarbazepine in mice.
2008 Jun
Eyeblink conditioning anomalies in bipolar disorder suggest cerebellar dysfunction.
2009 Feb
Binding of licarbazepine enantiomers to mouse and human plasma proteins.
2010 Jul
Development and validation of an HPLC-UV method for the simultaneous quantification of carbamazepine, oxcarbazepine, eslicarbazepine acetate and their main metabolites in human plasma.
2010 Jun
Patents

Patents

04540514
2
08530647
3
CA2703313C
2
JP1045367A
2
JP2009519467A
53
JP2011507800A
48
US8372431
2
WO2005092294A1
2

Sample Use Guides

In Vivo Use Guide
Bipolar I Disorder: 750- 2000 mg/day
Route of Administration: Oral
In Vitro Use Guide
Free and bound fractions of S-licarbazepine (S-Lic) and R-licarbazepine (R-Lic) were separated by ultrafiltration after previous in vitro incubation of spiked plasma samples and protein solutions with each enantiomer at 10, 25 and 50 ug/ml.
Substance Class Chemical
Created
by admin
on Fri Dec 15 15:06:08 GMT 2023
Edited
by admin
on Fri Dec 15 15:06:08 GMT 2023
Record UNII
VZI5B1W380
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
OXCARBAZEPINE
HSDB   INN   MART.   MI   ORANGE BOOK   USAN   USP   USP-RS   VANDF   WHO-DD  
USAN   INN  
Official Name English
OXCARBAZEPINE [VANDF]
Common Name English
TRILEPTAL
Common Name English
oxcarbazepine [INN]
Common Name English
OXCARBAMAZEPINE
Common Name English
OXCARBAZEPINE [HSDB]
Common Name English
OXCARBAZEPINE [USP MONOGRAPH]
Common Name English
KIN-493
Code English
OXCARBAZEPINE [USAN]
Common Name English
OXCARBAZEPINE [MI]
Common Name English
OXCARBAZEPINE [JAN]
Common Name English
GP-47680
Code English
Oxcarbazepine [WHO-DD]
Common Name English
NSC-758693
Code English
OXCARBAZEPINE [EP MONOGRAPH]
Common Name English
SPN-804
Code English
10,11-DIHYDRO-10-OXO-5H-DIBENZ(B,F)AZEPINE-5-CARBOXAMIDE
Systematic Name English
OXCARBAZEPINE [ORANGE BOOK]
Common Name English
OXCARBAZEPINE [USP-RS]
Common Name English
OXCARBAZEPINE [MART.]
Common Name English
5H-DIBENZ(B,F)AZEPINE-5-CARBOXAMIDE, 10,11-DIHYDRO-10-OXO-
Systematic Name English
OXTELLAR XR
Brand Name English
Classification Tree Code System Code
NCI_THESAURUS C264
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
LIVERTOX NBK548414
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
NDF-RT N0000008486
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
NDF-RT N0000175753
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
WHO-VATC QN03AF02
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
WHO-ATC N03AF02
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
Code System Code Type Description
DRUG BANK
DB00776
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
CAS
28721-07-5
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
EVMPD
SUB32960
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
INN
4585
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
WIKIPEDIA
OXCARBAZEPINE
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
EVMPD
SUB09510MIG
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
USAN
MM-02
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
HSDB
7524
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
LACTMED
Oxcarbazepine
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
IUPHAR
7254
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
ECHA (EC/EINECS)
249-188-8
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
DAILYMED
VZI5B1W380
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
MESH
C036006
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
RS_ITEM_NUM
1483152
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
FDA UNII
VZI5B1W380
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
DRUG CENTRAL
2017
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
RXCUI
32624
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY RxNorm
NSC
758693
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
SMS_ID
100000092224
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
PUBCHEM
34312
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
CHEBI
7824
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
MERCK INDEX
m8298
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY Merck Index
EPA CompTox
DTXSID0045703
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
ChEMBL
CHEMBL1068
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
NCI_THESAURUS
C47643
Created by admin on Fri Dec 15 15:06:08 GMT 2023 , Edited by admin on Fri Dec 15 15:06:08 GMT 2023
PRIMARY
Related Record Type Details
Structure of OXCARBAZEPINE
BASIS OF STRENGTH->SUBSTANCE
ASSAY (HPLC)
USP
CYTOCHROME P450 2C19
METABOLIC ENZYME -> INHIBITOR
Ki
CYTOCHROME P450 3A5
METABOLIC ENZYME -> INDUCER
CHROMATOGRAPHIC PURITY (HPLC/UV)
Ki
Structure of OXCARBAZEPINE
EXCRETED UNCHANGED
AMOUNT EXCRETED
URINE
PLASMA PROTEIN FRACTION (HUMAN)
BINDER->LIGAND
BINDING
Structure of OXCARBAZEPINE
BASIS OF STRENGTH->SUBSTANCE
ASSAY (HPLC)
EP
CYTOCHROME P450 3A4
METABOLIC ENZYME -> INDUCER
Ki
Related Record Type Details
Structure of OXCARBAZEPINE ALCOHOL SULFATE
METABOLITE -> PARENT
Structure of LICARBAZEPINE GLUCURONIDE, (R)-
METABOLITE -> PARENT
Structure of LICARBAZEPINE
METABOLITE ACTIVE -> PRODRUG
Structure of 10,11-DIHYDROXY-10,11-DIHYDROCARBAZEPINE, TRANS-
METABOLITE -> PARENT
Structure of LICARBAZEPINE, (R)-
METABOLITE -> PARENT
Structure of 10,11-DIHYDROXY-10,11-DIHYDROCARBAZEPINE, CIS-
METABOLITE -> PARENT
Structure of .BETA.-D-GLUCOPYRANOSIDURONIC ACID, 5-(AMINOCARBONYL)-10,11-DIHYDRO-5H-DIBENZ(B,F)AZEPIN-10-YL
METABOLITE -> PARENT
Structure of ESLICARBAZEPINE GLUCURONIDE
METABOLITE -> PARENT
Related Record Type Details
Structure of 10-METHOXYIMINOSTILBENE
IMPURITY -> PARENT
UNSPECIFIED
EP
Structure of DE(5-CARBOXAMIDE)OXCARBAZEPINE
IMPURITY -> PARENT
UNSPECIFIED
EP
Structure of N-FORMYL OXCARBAZEPINE
IMPURITY -> PARENT
sum of impurities K and L: maximum 0.1 per cent
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
Structure of 5-ETHYL-10-METHOXY DIBENZAZEPINE
IMPURITY -> PARENT
UNSPECIFIED
EP
Structure of 1-(10-METHOXY-5H-DIBENZO(B,F)AZEPIN-5-YL)ETHANONE
IMPURITY -> PARENT
Structure of N-ACETYL OXCARBAZEPINE
IMPURITY -> PARENT
sum of impurities K and L: maximum 0.1 per cent
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
Structure of CARBAMAZEPINE
IMPURITY -> PARENT
UNSPECIFIED
EP
Structure of 10-METHOXYIMINOSTILBENE-5-CARBONYLCHLORIDE
IMPURITY -> PARENT
UNSPECIFIED
EP
Structure of DIBENZAZEPINE-10,11-DIONE
IMPURITY -> PARENT
UNSPECIFIED
EP
Structure of 10-(10-OXO-10,11-DIHYDRO-5H-DIBENZO(B,F)AZEPINE-5-CARBOXAMIDO)-5H-DIBENZO(B,F)AZEPINE-5-CARBOXAMIDE
IMPURITY -> PARENT
UNSPECIFIED
EP
Structure of 10-METHOXYCARBAMAZEPINE
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
Structure of DIBENZAZEPINE
IMPURITY -> PARENT
UNSPECIFIED
EP
Structure of 11-KETO OXCARBAZEPINE
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
Related Record Type Details
Structure of LICARBAZEPINE
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
Tmax PHARMACOKINETIC FASTED CONDITION

SINGLE DOSE ADMINISTRATION

HEALTHY MALE SUBJECTS

Volume of Distribution PHARMACOKINETIC
Structure of OXCARBAZEPINE
MHD
PHARMACOKINETIC
Biological Half-life PHARMACOKINETIC
Structure of OXCARBAZEPINE
MHD
PHARMACOKINETIC
Extended Release; Parent drug
PHARMACOKINETIC
Immediate release; Parent drug
PHARMACOKINETIC
MHD
PHARMACOKINETIC
Immediate release; MHD
PHARMACOKINETIC
NIH
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