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felbamate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| tranquillizers, propanediol and pentanediol derivatives | 1140 | 25451-15-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A PEGylated phenylcarbamate derivative that acts as an antagonist of NMDA RECEPTORS. It is used as an anticonvulsant, primarily for the treatment of SEIZURES in severe refractory EPILEPSY.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 2.40 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 4 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.74 mg/mL | Bocci G, Oprea TI, Benet LZ |
| EoM (Fraction excreted unchanged in urine) | 45 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 251.84 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 90 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,MAP3K21,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,SIK2,SIK3,STK33,TEK,TTK | 31 | |||
| kinase-selectivity-class | AXL,CAMK2D,FLT3,GRK2,JAK2,MAP2K6,MAPK7,PDK4,SIK2,STK33,TEK | 11 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pld-class | Phospholipidosis risk class (1 = positive, 0 = negative) | 0 | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 29, 1993 | FDA | MEDA PHARMS |
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 | 197.73 | 58.17 | 70 | 892 | 152559 | 90474926 |
| Electrocardiogram ST segment elevation | 79.02 | 58.17 | 16 | 946 | 4000 | 90623485 |
| Laryngeal stenosis | 75.74 | 58.17 | 13 | 949 | 1326 | 90626159 |
| Unmasking of previously unidentified disease | 74.48 | 58.17 | 13 | 949 | 1463 | 90626022 |
| Electrocardiogram repolarisation abnormality | 68.62 | 58.17 | 12 | 950 | 1364 | 90626121 |
| Multiple-drug resistance | 68.49 | 58.17 | 16 | 946 | 7760 | 90619725 |
| Systolic dysfunction | 64.73 | 58.17 | 12 | 950 | 1892 | 90625593 |
| Tachycardia | 64.58 | 58.17 | 32 | 930 | 157641 | 90469844 |
| Electrocardiogram QRS complex prolonged | 64.08 | 58.17 | 15 | 947 | 7333 | 90620152 |
| Cardiotoxicity | 62.42 | 58.17 | 16 | 946 | 11373 | 90616112 |
| Drug reaction with eosinophilia and systemic symptoms | 60.20 | 58.17 | 21 | 941 | 42737 | 90584748 |
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 | 308.59 | 49.40 | 112 | 892 | 120449 | 42499882 |
| Drug ineffective | 88.09 | 49.40 | 89 | 915 | 630108 | 41990223 |
| Generalised tonic-clonic seizure | 87.37 | 49.40 | 30 | 974 | 26349 | 42593982 |
| Benzodiazepine drug level decreased | 55.08 | 49.40 | 7 | 997 | 35 | 42620296 |
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 | 356.28 | 46.74 | 132 | 1608 | 221053 | 110366506 |
| Multiple-drug resistance | 99.91 | 46.74 | 26 | 1714 | 13209 | 110574350 |
| Generalised tonic-clonic seizure | 95.90 | 46.74 | 35 | 1705 | 54645 | 110532914 |
| Drug ineffective | 95.21 | 46.74 | 117 | 1623 | 1520423 | 109067136 |
| Laryngeal stenosis | 70.04 | 46.74 | 13 | 1727 | 1385 | 110586174 |
| Unmasking of previously unidentified disease | 60.72 | 46.74 | 13 | 1727 | 2855 | 110584704 |
| Electrocardiogram ST segment elevation | 59.57 | 46.74 | 16 | 1724 | 9144 | 110578415 |
| Benzodiazepine drug level decreased | 57.89 | 46.74 | 7 | 1733 | 35 | 110587524 |
| Petit mal epilepsy | 57.77 | 46.74 | 15 | 1725 | 7532 | 110580027 |
| Electrocardiogram repolarisation abnormality | 57.54 | 46.74 | 12 | 1728 | 2323 | 110585236 |
| Somnolence | 57.48 | 46.74 | 43 | 1697 | 297406 | 110290153 |
| Toxicity to various agents | 54.46 | 46.74 | 51 | 1689 | 480504 | 110107055 |
| Systolic dysfunction | 49.93 | 46.74 | 12 | 1728 | 4403 | 110583156 |
| Cardiotoxicity | 49.91 | 46.74 | 16 | 1724 | 16865 | 110570694 |
| Electrocardiogram QRS complex prolonged | 49.67 | 46.74 | 15 | 1725 | 13006 | 110574553 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N03AX10 | NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Other antiepileptics |
| FDA PE | N0000008486 | Decreased Central Nervous System Disorganized Electrical Activity |
| MeSH PA | D000927 | Anticonvulsants |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D018691 | Excitatory Amino Acid Antagonists |
| CHEBI has role | CHEBI:35476 | antipsychotic agent |
| CHEBI has role | CHEBI:35623 | anticonvulsant |
| CHEBI has role | CHEBI:63726 | neuroprotective agent |
| CHEBI has role | CHEBI:75835 | anti-anaemic agent |
| FDA EPC | N0000175753 | Anti-epileptic Agent |
Related Drugs by ATC class:
N03AX Other antiepileptics 18 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Epilepsy | indication | 84757009 | DOID:1826 |
| Lennox-Gastaut syndrome | indication | 230418006 | |
| Simple partial seizure | indication | 117891000119100 | |
| Suicidal thoughts | contraindication | 6471006 | |
| Torsades de pointes | contraindication | 31722008 | |
| Depressive disorder | contraindication | 35489007 | |
| Hepatic failure | contraindication | 59927004 | |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Prolonged QT interval | contraindication | 111975006 | |
| Liver function tests abnormal | contraindication | 166603001 | |
| Disease of blood AND/OR blood-forming organ | contraindication | 191124002 | DOID:74 |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Aplastic anemia | contraindication | 306058006 | DOID:12449 |
| Bone marrow depression | contraindication | 307762000 | |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Porphyria | contraindication | 418470004 | |
| Congenital long QT syndrome | contraindication | 442917000 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 13.24 | acidic |
| pKa2 | 13.84 | acidic |
Orange Book patent data (new drug applications)
None
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 |
|---|---|---|---|---|---|---|---|---|---|
| Glutamate receptor ionotropic, NMDA 2A | Ion channel | ANTAGONIST | DRUGBANK | CHEMBL | |||||
| Glutamate receptor ionotropic, NMDA 2B | Ion channel | ANTAGONIST | IC50 | 4.28 | WOMBAT-PK | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4020832 | VUID |
| N0000148344 | NUI |
| D00536 | KEGG_DRUG |
| 4020832 | VANDF |
| C0060135 | UMLSCUI |
| CHEBI:4995 | CHEBI |
| CHEMBL1094 | ChEMBL_ID |
| DB00949 | DRUGBANK_ID |
| D000078328 | MESH_DESCRIPTOR_UI |
| 3331 | PUBCHEM_CID |
| 5473 | IUPHAR_LIGAND_ID |
| 5686 | INN_ID |
| X72RBB02N8 | UNII |
| 224900 | RXNORM |
| 185493 | MMSL |
| 3074 | MMSL |
| 4715 | MMSL |
| d03170 | MMSL |
| 004277 | NDDF |
| 371387009 | SNOMEDCT_US |
| 96194006 | SNOMEDCT_US |
| X72RBB02N8 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Felbatol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0037-0430 | TABLET | 400 mg | ORAL | NDA | 33 sections |
| Felbatol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0037-0431 | TABLET | 600 mg | ORAL | NDA | 33 sections |
| Felbatol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0037-0442 | SUSPENSION | 600 mg | ORAL | NDA | 33 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10135-601 | TABLET | 400 mg | ORAL | ANDA | 28 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10135-602 | TABLET | 600 mg | ORAL | ANDA | 28 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-775 | SUSPENSION | 600 mg | ORAL | ANDA | 33 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51672-4172 | SUSPENSION | 600 mg | ORAL | ANDA | 33 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51672-4185 | TABLET | 400 mg | ORAL | ANDA | 33 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51672-4186 | TABLET | 600 mg | ORAL | ANDA | 33 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53746-734 | TABLET | 400 mg | ORAL | ANDA | 15 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53746-735 | TABLET | 600 mg | ORAL | ANDA | 15 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62559-730 | TABLET | 400 mg | ORAL | ANDA | 31 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62559-730 | TABLET | 400 mg | ORAL | ANDA | 31 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62559-731 | TABLET | 600 mg | ORAL | ANDA | 31 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62559-731 | TABLET | 600 mg | ORAL | ANDA | 31 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63629-1937 | TABLET | 400 mg | ORAL | ANDA | 31 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63629-1944 | TABLET | 600 mg | ORAL | ANDA | 31 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65162-686 | SUSPENSION | 600 mg | ORAL | ANDA | 16 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65162-734 | TABLET | 400 mg | ORAL | ANDA | 15 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65162-735 | TABLET | 600 mg | ORAL | ANDA | 15 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68151-4474 | TABLET | 600 mg | ORAL | ANDA | 15 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70771-1077 | TABLET | 400 mg | ORAL | ANDA | 2 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70771-1078 | TABLET | 600 mg | ORAL | ANDA | 2 sections |
| Felbamate | Human Prescription Drug Label | 1 | 70954-051 | SUSPENSION | 600 mg | ORAL | ANDA | 16 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72162-1770 | TABLET | 400 mg | ORAL | ANDA | 31 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72162-1771 | TABLET | 600 mg | ORAL | ANDA | 31 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72578-056 | TABLET | 400 mg | ORAL | ANDA | 27 sections |
| Felbamate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72578-057 | TABLET | 600 mg | ORAL | ANDA | 27 sections |