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fosphenytoin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antiepileptics, hydantoin derivatives | 1247 | 93390-81-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.45 | g | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 0.06 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 3.50 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.05 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 0.16 hours | Lombardo F, Berellini G, Obach RS |
| S (Water solubility) | 142 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
| BA (Bioavailability) | 0 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GRK3,GSK3B,IGF1R,ITK,JAK1,JAK2,JAK3,MAP2K6,MAP3K14,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 | 55 | |||
| kinase-selectivity-class | AURKA,AXL,BRAF,CDK4,CDK9,DDR1,EPHB4,ERBB2,GRK2,MAP2K6,MAPK7,PAK4,PDK4,PIK3CD,PRKDC,SIK2,STK33,SYK,TEK,ZAP70 | 20 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 5, 1996 | FDA | PARKE DAVIS |
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 |
|---|---|---|---|---|---|---|
| Drug ineffective | 306.10 | 47.98 | 275 | 2345 | 1384023 | 89241804 |
| Multiple-drug resistance | 237.29 | 47.98 | 53 | 2567 | 7723 | 90618104 |
| Status epilepticus | 172.38 | 47.98 | 49 | 2571 | 18825 | 90607002 |
| Myocardial depression | 148.42 | 47.98 | 24 | 2596 | 609 | 90625218 |
| Macroglossia | 113.47 | 47.98 | 20 | 2600 | 859 | 90624968 |
| Drug ineffective for unapproved indication | 111.92 | 47.98 | 49 | 2571 | 66595 | 90559232 |
| Cardiac arrest | 107.92 | 47.98 | 55 | 2565 | 104880 | 90520947 |
| Off label use | 107.53 | 47.98 | 144 | 2476 | 1102108 | 89523719 |
| Oropharyngeal oedema | 79.45 | 47.98 | 13 | 2607 | 355 | 90625472 |
| Atrioventricular block | 71.98 | 47.98 | 21 | 2599 | 8794 | 90617033 |
| Seizure | 71.34 | 47.98 | 48 | 2572 | 152581 | 90473246 |
| Acquired macroglossia | 63.45 | 47.98 | 10 | 2610 | 214 | 90625613 |
| Laryngeal stenosis | 62.69 | 47.98 | 13 | 2607 | 1326 | 90624501 |
| Hepatic function abnormal | 52.59 | 47.98 | 26 | 2594 | 46262 | 90579565 |
| Drug reaction with eosinophilia and systemic symptoms | 48.52 | 47.98 | 24 | 2596 | 42734 | 90583093 |
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 |
|---|---|---|---|---|---|---|
| Drug ineffective | 198.56 | 36.54 | 204 | 2141 | 629993 | 41988997 |
| Status epilepticus | 188.01 | 36.54 | 58 | 2287 | 15520 | 42603470 |
| Multiple-drug resistance | 113.02 | 36.54 | 33 | 2312 | 7289 | 42611701 |
| Seizure | 66.35 | 36.54 | 54 | 2291 | 120507 | 42498483 |
| Drug ineffective for unapproved indication | 56.96 | 36.54 | 34 | 2311 | 46129 | 42572861 |
| Rhabdomyolysis | 47.22 | 36.54 | 37 | 2308 | 77982 | 42541008 |
| Haemodynamic instability | 44.73 | 36.54 | 19 | 2326 | 12538 | 42606452 |
| Nystagmus | 44.18 | 36.54 | 15 | 2330 | 5381 | 42613609 |
| Off label use | 43.95 | 36.54 | 103 | 2242 | 638232 | 41980758 |
| Cardiac arrest | 40.15 | 36.54 | 39 | 2306 | 109281 | 42509709 |
| Anticonvulsant drug level below therapeutic | 39.93 | 36.54 | 9 | 2336 | 708 | 42618282 |
| Hypotension | 38.31 | 36.54 | 58 | 2287 | 257573 | 42361417 |
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 |
|---|---|---|---|---|---|---|
| Drug ineffective | 457.84 | 35.34 | 429 | 4327 | 1520111 | 109064432 |
| Status epilepticus | 332.32 | 35.34 | 100 | 4656 | 31471 | 110553072 |
| Multiple-drug resistance | 225.10 | 35.34 | 61 | 4695 | 13174 | 110571369 |
| Drug ineffective for unapproved indication | 136.59 | 35.34 | 73 | 4683 | 102765 | 110481778 |
| Myocardial depression | 128.75 | 35.34 | 23 | 4733 | 709 | 110583834 |
| Cardiac arrest | 120.19 | 35.34 | 85 | 4671 | 196668 | 110387875 |
| Off label use | 110.75 | 35.34 | 215 | 4541 | 1499970 | 109084573 |
| Seizure | 109.07 | 35.34 | 84 | 4672 | 221101 | 110363442 |
| Macroglossia | 101.16 | 35.34 | 21 | 4735 | 1440 | 110583103 |
| Nystagmus | 77.41 | 35.34 | 26 | 4730 | 11551 | 110572992 |
| Oropharyngeal oedema | 71.24 | 35.34 | 13 | 4743 | 452 | 110584091 |
| Anticonvulsant drug level below therapeutic | 70.64 | 35.34 | 15 | 4741 | 1147 | 110583396 |
| Drug reaction with eosinophilia and systemic symptoms | 65.69 | 35.34 | 42 | 4714 | 82053 | 110502490 |
| Propofol infusion syndrome | 63.62 | 35.34 | 16 | 4740 | 2573 | 110581970 |
| Hepatic function abnormal | 62.46 | 35.34 | 42 | 4714 | 89253 | 110495290 |
| Rhabdomyolysis | 62.03 | 35.34 | 47 | 4709 | 120354 | 110464189 |
| Hypotension | 61.91 | 35.34 | 93 | 4663 | 523756 | 110060787 |
| Bradycardia | 59.50 | 35.34 | 51 | 4705 | 155466 | 110429077 |
| Acquired macroglossia | 57.68 | 35.34 | 10 | 4746 | 258 | 110584285 |
| Laryngeal stenosis | 56.97 | 35.34 | 13 | 4743 | 1385 | 110583158 |
| Atrioventricular block | 53.83 | 35.34 | 22 | 4734 | 16855 | 110567688 |
| Anticonvulsant drug level above therapeutic | 47.50 | 35.34 | 11 | 4745 | 1251 | 110583292 |
| Respiratory depression | 46.04 | 35.34 | 24 | 4732 | 31977 | 110552566 |
| Anticonvulsant drug level increased | 43.11 | 35.34 | 12 | 4744 | 2846 | 110581697 |
| Blood pressure decreased | 42.49 | 35.34 | 37 | 4719 | 115054 | 110469489 |
| Drug interaction | 40.48 | 35.34 | 75 | 4681 | 500108 | 110084435 |
| Altered state of consciousness | 40.03 | 35.34 | 27 | 4729 | 57599 | 110526944 |
| Electrocardiogram QRS complex prolonged | 38.22 | 35.34 | 16 | 4740 | 13005 | 110571538 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N03AB05 | NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Hydantoin 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 |
| CHEBI has role | CHEBI:35623 | anticonvulsant |
| FDA EPC | N0000175753 | Anti-epileptic Agent |
Related Drugs by ATC class:
N03AB Hydantoin derivatives 4 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Epilepsy | indication | 84757009 | DOID:1826 |
| Status epilepticus | indication | 230456007 | DOID:1824 |
| Epilepsy characterized by intractable complex partial seizures | indication | 442481002 | |
| Seizures in Neurosurgery | indication | ||
| Alcoholism | contraindication | 7200002 | |
| Hyperphosphatemia | contraindication | 20165001 | DOID:0050459 |
| Complete atrioventricular block | contraindication | 27885002 | |
| Lymphadenopathy | contraindication | 30746006 | |
| Torsades de pointes | contraindication | 31722008 | |
| Conduction disorder of the heart | contraindication | 44808001 | |
| Low blood pressure | contraindication | 45007003 | |
| Stokes-Adams syndrome | contraindication | 46935006 | |
| Sinus bradycardia | contraindication | 49710005 | |
| Systemic lupus erythematosus | contraindication | 55464009 | DOID:9074 |
| Leukopenia | contraindication | 84828003 | DOID:615 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Prolonged QT interval | contraindication | 111975006 | |
| Hypoalbuminemia | contraindication | 119247004 | |
| Pancytopenia | contraindication | 127034005 | DOID:12450 |
| Second degree atrioventricular block | contraindication | 195042002 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Pregnancy, function | contraindication | 289908002 | |
| Thrombocytopenic disorder | contraindication | 302215000 | DOID:1588 |
| Granulocytopenic disorder | contraindication | 417672002 | |
| Congenital long QT syndrome | contraindication | 442917000 | |
| HLA-B 1502 Positive Status | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 0.77 | acidic |
| pKa2 | 5.83 | acidic |
| pKa3 | 8.0 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Sodium channel protein type 5 subunit alpha | Ion channel | BLOCKER | DRUGBANK | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4024030 | VUID |
| N0000022035 | NUI |
| D02096 | KEGG_DRUG |
| 92134-98-0 | SECONDARY_CAS_RN |
| 4020973 | VANDF |
| 4024030 | VANDF |
| C0244656 | UMLSCUI |
| CHEBI:5165 | CHEBI |
| CHEMBL1201336 | ChEMBL_ID |
| DB01320 | DRUGBANK_ID |
| CHEMBL919 | ChEMBL_ID |
| C043114 | MESH_SUPPLEMENTAL_RECORD_UI |
| 56339 | PUBCHEM_CID |
| 7190 | IUPHAR_LIGAND_ID |
| 6484 | INN_ID |
| B4SF212641 | UNII |
| 134860 | RXNORM |
| 117573 | MMSL |
| 4767 | MMSL |
| 6028 | MMSL |
| d04041 | MMSL |
| 006181 | NDDF |
| 006182 | NDDF |
| 108397000 | SNOMEDCT_US |
| 372484000 | SNOMEDCT_US |
| 386843000 | SNOMEDCT_US |
| B4SF212641 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| CEREBYX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-5471 | INJECTION, SOLUTION | 50 mg | INTRAVENOUS | NDA | 27 sections |
| CEREBYX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-5474 | INJECTION, SOLUTION | 50 mg | INTRAVENOUS | NDA | 27 sections |
| CEREBYX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-6001 | INJECTION, SOLUTION | 50 mg | INTRAVENOUS | NDA | 29 sections |
| Fosphenytoin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9782 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 26 sections |
| Fosphenytoin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9788 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 26 sections |
| Fosphenytoin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6136 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 26 sections |
| Fosphenytoin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6137 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 26 sections |
| Fosphenytoin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 25021-798 | INJECTION, SOLUTION | 50 mg | INTRAVENOUS | ANDA | 31 sections |
| Fosphenytoin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63323-403 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 31 sections |
| Fosphenytoin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65162-998 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 18 sections |
| Fosphenytoin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65162-999 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 18 sections |
| Fosphenytoin sodium | Human Prescription Drug Label | 1 | 68083-460 | INJECTION, SOLUTION | 50 mg | INTRAVENOUS | ANDA | 26 sections |
| Fosphenytoin sodium | Human Prescription Drug Label | 1 | 68083-461 | INJECTION, SOLUTION | 50 mg | INTRAVENOUS | ANDA | 26 sections |
| Fosphenytoin sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68462-621 | INJECTION, SOLUTION | 50 mg | INTRAVENOUS | ANDA | 25 sections |
| Fosphenytoin sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68462-622 | INJECTION, SOLUTION | 50 mg | INTRAVENOUS | ANDA | 25 sections |
| Fosphenytoin sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68462-945 | INJECTION, SOLUTION | 50 mg | INTRAVENOUS | ANDA | 25 sections |