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eslicarbazepine acetate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4303 | 236395-14-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Eslicarbazepine acetate is extensively converted to eslicarbazepine, which is considered to be responsible for therapeutic effects in humans. The precise mechanism(s) by which eslicarbazepine exerts anticonvulsant activity is unknown but is thought to involve inhibition of voltage-gated sodium channels.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.80 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 4.20 mg/mL | Bocci G, Oprea TI, Benet LZ |
| fu (Fraction unbound in plasma) | 0.39 % | Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K |
| BA (Bioavailability) | 95 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,MAPK7,PDK1,PDK2,PDK4,PIK3CB,PRKDC,STK33,TEK,TTK | 20 | |||
| kinase-selectivity-class | ACVR2B,AXL,BRAF,GRK2,MAP2K6,PDK4,STK33 | 7 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 8, 2013 | FDA | SUNOVION PHARMS INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Seizure | 270.21 | 42.73 | 99 | 1396 | 152530 | 90474422 |
| Hyponatraemia | 168.90 | 42.73 | 68 | 1427 | 133470 | 90493482 |
| Generalised tonic-clonic seizure | 81.59 | 42.73 | 28 | 1467 | 34875 | 90592077 |
| Axillary lymphadenectomy | 50.04 | 42.73 | 7 | 1488 | 116 | 90626836 |
| Drug dose titration not performed | 43.58 | 42.73 | 8 | 1487 | 764 | 90626188 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Seizure | 271.27 | 43.11 | 103 | 936 | 120458 | 42499838 |
| Drug ineffective | 61.05 | 43.11 | 75 | 964 | 630122 | 41990174 |
| Hyponatraemia | 58.06 | 43.11 | 34 | 1005 | 101428 | 42518868 |
| Status epilepticus | 51.99 | 43.11 | 18 | 1021 | 15560 | 42604736 |
| Multiple-drug resistance | 47.34 | 43.11 | 14 | 1025 | 7308 | 42612988 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Seizure | 350.45 | 37.75 | 138 | 1993 | 221047 | 110366121 |
| Hyponatraemia | 179.57 | 37.75 | 86 | 2045 | 217567 | 110369601 |
| Generalised tonic-clonic seizure | 68.37 | 37.75 | 29 | 2102 | 54651 | 110532517 |
| Multiple-drug resistance | 63.24 | 37.75 | 19 | 2112 | 13216 | 110573952 |
| Status epilepticus | 57.65 | 37.75 | 22 | 2109 | 31549 | 110555619 |
| Petit mal epilepsy | 54.74 | 37.75 | 15 | 2116 | 7532 | 110579636 |
| Drug ineffective | 54.53 | 37.75 | 101 | 2030 | 1520439 | 109066729 |
| Axillary lymphadenectomy | 50.47 | 37.75 | 7 | 2124 | 92 | 110587076 |
| Somnolence | 49.71 | 37.75 | 43 | 2088 | 297406 | 110289762 |
| Inappropriate antidiuretic hormone secretion | 45.79 | 37.75 | 19 | 2112 | 33832 | 110553336 |
| Psychomotor skills impaired | 41.93 | 37.75 | 12 | 2119 | 7046 | 110580122 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N03AF04 | NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Carboxamide derivatives |
| FDA PE | N0000008486 | Decreased Central Nervous System Disorganized Electrical Activity |
| MeSH PA | D000927 | Anticonvulsants |
| MeSH PA | D002317 | Cardiovascular Agents |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D026941 | Sodium Channel Blockers |
| MeSH PA | D049990 | Membrane Transport Modulators |
| MeSH PA | D061567 | Voltage-Gated Sodium Channel Blockers |
| FDA MoA | N0000182140 | Cytochrome P450 2C19 Inhibitors |
| FDA MoA | N0000185506 | Cytochrome P450 3A4 Inducers |
| CHEBI has role | CHEBI:35476 | antipsychotic agent |
| CHEBI has role | CHEBI:35623 | anticonvulsant |
| CHEBI has role | CHEBI:88188 | drug allergen |
Related Drugs by ATC class:
N03AF Carboxamide derivatives 3 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Partial seizure | indication | 29753000 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 13.73 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 200MG | APTIOM | SUMITOMO PHARMA AM | N022416 | Nov. 8, 2013 | RX | TABLET | ORAL | 9763954 | Sept. 13, 2028 | TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS WITH EPILEPSY WHO HAVE BEEN PREVIOUSLY TREATED WITH OXCARBAZEPINE |
| 400MG | APTIOM | SUMITOMO PHARMA AM | N022416 | Nov. 8, 2013 | RX | TABLET | ORAL | 9763954 | Sept. 13, 2028 | TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS WITH EPILEPSY WHO HAVE BEEN PREVIOUSLY TREATED WITH OXCARBAZEPINE |
| 600MG | APTIOM | SUMITOMO PHARMA AM | N022416 | Nov. 8, 2013 | RX | TABLET | ORAL | 9763954 | Sept. 13, 2028 | TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS WITH EPILEPSY WHO HAVE BEEN PREVIOUSLY TREATED WITH OXCARBAZEPINE |
| 800MG | APTIOM | SUMITOMO PHARMA AM | N022416 | Nov. 8, 2013 | RX | TABLET | ORAL | 9763954 | Sept. 13, 2028 | TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS WITH EPILEPSY WHO HAVE BEEN PREVIOUSLY TREATED WITH OXCARBAZEPINE |
| 200MG | APTIOM | SUMITOMO PHARMA AM | N022416 | Nov. 8, 2013 | RX | TABLET | ORAL | 9750747 | Aug. 24, 2032 | TREATMENT OF PARTIAL-ONSET SEIZURES |
| 200MG | APTIOM | SUMITOMO PHARMA AM | N022416 | Nov. 8, 2013 | RX | TABLET | ORAL | 9750747 | Aug. 24, 2032 | TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT SUFFERING FROM OR SUSCEPTIBLE TO ABSENCE SEIZURES |
| 400MG | APTIOM | SUMITOMO PHARMA AM | N022416 | Nov. 8, 2013 | RX | TABLET | ORAL | 9750747 | Aug. 24, 2032 | TREATMENT OF PARTIAL-ONSET SEIZURES |
| 400MG | APTIOM | SUMITOMO PHARMA AM | N022416 | Nov. 8, 2013 | RX | TABLET | ORAL | 9750747 | Aug. 24, 2032 | TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT SUFFERING FROM OR SUSCEPTIBLE TO ABSENCE SEIZURES |
| 600MG | APTIOM | SUMITOMO PHARMA AM | N022416 | Nov. 8, 2013 | RX | TABLET | ORAL | 9750747 | Aug. 24, 2032 | TREATMENT OF PARTIAL-ONSET SEIZURES |
| 600MG | APTIOM | SUMITOMO PHARMA AM | N022416 | Nov. 8, 2013 | RX | TABLET | ORAL | 9750747 | Aug. 24, 2032 | TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT SUFFERING FROM OR SUSCEPTIBLE TO ABSENCE SEIZURES |
| 800MG | APTIOM | SUMITOMO PHARMA AM | N022416 | Nov. 8, 2013 | RX | TABLET | ORAL | 9750747 | Aug. 24, 2032 | TREATMENT OF PARTIAL-ONSET SEIZURES |
| 800MG | APTIOM | SUMITOMO PHARMA AM | N022416 | Nov. 8, 2013 | RX | TABLET | ORAL | 9750747 | Aug. 24, 2032 | TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT SUFFERING FROM OR SUSCEPTIBLE TO ABSENCE SEIZURES |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Sodium channel alpha subunit | Ion channel | BLOCKER | CHEMBL | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4033118 | VUID |
| N0000190128 | NUI |
| D09215 | KEGG_DRUG |
| 4033116 | VANDF |
| 4033118 | VANDF |
| C2725262 | UMLSCUI |
| CHEMBL87992 | ChEMBL_ID |
| DB09119 | DRUGBANK_ID |
| C416835 | MESH_SUPPLEMENTAL_RECORD_UI |
| BEA68ZVB2K | UNII |
| 179344 | PUBCHEM_CID |
| DB14575 | DRUGBANK_ID |
| 1482501 | RXNORM |
| 207443 | MMSL |
| 29871 | MMSL |
| 394837 | MMSL |
| d07507 | MMSL |
| 013276 | NDDF |
| 013277 | NDDF |
| 697998007 | SNOMEDCT_US |
| 700015007 | SNOMEDCT_US |
| 715615002 | SNOMEDCT_US |
| C2725260 | UMLSCUI |
| CHEMBL315985 | ChEMBL_ID |
| 104746-04-5 | SECONDARY_CAS_RN |
| 9881504 | PUBCHEM_CID |
| 7350 | IUPHAR_LIGAND_ID |
| 8403 | INN_ID |
| C571001 | MESH_SUPPLEMENTAL_RECORD_UI |
| S5VXA428R4 | UNII |
| CHEBI:174358 | CHEBI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Eslicarbazepine acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13668-538 | TABLET | 200 mg | ORAL | ANDA | 30 sections |
| Eslicarbazepine acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13668-539 | TABLET | 400 mg | ORAL | ANDA | 30 sections |
| Eslicarbazepine acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13668-540 | TABLET | 600 mg | ORAL | ANDA | 30 sections |
| Eslicarbazepine acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13668-541 | TABLET | 800 mg | ORAL | ANDA | 30 sections |
| Eslicarbazepine acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-428 | TABLET | 200 mg | ORAL | ANDA | 31 sections |
| Eslicarbazepine acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-429 | TABLET | 400 mg | ORAL | ANDA | 31 sections |
| Eslicarbazepine acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-430 | TABLET | 600 mg | ORAL | ANDA | 31 sections |
| Eslicarbazepine acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-431 | TABLET | 800 mg | ORAL | ANDA | 31 sections |
| Eslicarbazepine Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-684 | TABLET | 200 mg | ORAL | ANDA | 30 sections |
| Eslicarbazepine Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-685 | TABLET | 400 mg | ORAL | ANDA | 30 sections |
| Eslicarbazepine Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-686 | TABLET | 600 mg | ORAL | ANDA | 30 sections |
| Eslicarbazepine Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-687 | TABLET | 800 mg | ORAL | ANDA | 30 sections |
| Eslicarbazepine Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-779 | TABLET | 200 mg | ORAL | ANDA | 32 sections |
| Eslicarbazepine Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-780 | TABLET | 400 mg | ORAL | ANDA | 32 sections |
| Eslicarbazepine Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-781 | TABLET | 600 mg | ORAL | ANDA | 32 sections |
| Eslicarbazepine Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-782 | TABLET | 800 mg | ORAL | ANDA | 32 sections |
| Eslicarbazepine Acetate | Human Prescription Drug Label | 1 | 59746-717 | TABLET | 200 mg | ORAL | ANDA | 21 sections |
| Eslicarbazepine Acetate | Human Prescription Drug Label | 1 | 59746-718 | TABLET | 400 mg | ORAL | ANDA | 21 sections |
| Eslicarbazepine Acetate | Human Prescription Drug Label | 1 | 59746-719 | TABLET | 600 mg | ORAL | ANDA | 21 sections |
| Eslicarbazepine Acetate | Human Prescription Drug Label | 1 | 59746-720 | TABLET | 800 mg | ORAL | ANDA | 21 sections |
| Eslicarbazepine Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-4658 | TABLET | 200 mg | ORAL | ANDA | 32 sections |
| Eslicarbazepine Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-4659 | TABLET | 400 mg | ORAL | ANDA | 32 sections |
| Eslicarbazepine Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-4660 | TABLET | 600 mg | ORAL | ANDA | 32 sections |
| Eslicarbazepine Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-4661 | TABLET | 800 mg | ORAL | ANDA | 32 sections |
| Aptiom | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-202 | TABLET | 200 mg | ORAL | NDA | 32 sections |
| Aptiom | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-204 | TABLET | 400 mg | ORAL | NDA | 32 sections |
| Aptiom | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-206 | TABLET | 600 mg | ORAL | NDA | 32 sections |
| Aptiom | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-208 | TABLET | 800 mg | ORAL | NDA | 32 sections |
| Eslicarbazepine Acetate | Human Prescription Drug Label | 1 | 67877-585 | TABLET | 200 mg | ORAL | ANDA | 32 sections |
| Eslicarbazepine Acetate | Human Prescription Drug Label | 1 | 67877-586 | TABLET | 400 mg | ORAL | ANDA | 32 sections |