fosphenytoin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antiepileptics, hydantoin derivatives	1247	93390-81-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: fosphenytoin cerebyx fosphenytoin sodium fosphenytoin sodium hydrate	Molecular weight: 362.28 Formula: C16H15N2O6P CLOGP: 0.81 LIPINSKI: 0 HAC: 8 HDO: 3 TPSA: 116.17 ALOGS: -3.40 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

fosphenytoin
cerebyx
fosphenytoin sodium
fosphenytoin sodium hydrate

Molecular weight: 362.28
Formula: C16H15N2O6P
CLOGP: 0.81
LIPINSKI: 0
HAC: 8
HDO: 3
TPSA: 116.17
ALOGS: -3.40
ROTB: 5

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.45	g	P

ADMET properties:

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Property	Value	Reference
CL (Clearance)	3.50 mL/min/kg	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
t_half (Half-life)	0.16 hours	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.06 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.05 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Aug. 5, 1996	FDA	PARKE DAVIS

FDA Adverse Event Reporting System (Female)

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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	176.55	43.91	192	1926	1044573	62442331
Status epilepticus	171.36	43.91	48	2070	15185	63471719
Multiple-drug resistance	167.53	43.91	38	2080	5132	63481772
Macroglossia	88.45	43.91	16	2102	689	63486215
Drug ineffective for unapproved indication	79.54	43.91	33	2085	34030	63452874
Oropharyngeal oedema	78.29	43.91	13	2105	336	63486568
Laryngeal stenosis	63.65	43.91	13	2105	1065	63485839
Seizure	57.28	43.91	42	2076	132592	63354312
Acquired macroglossia	56.45	43.91	9	2109	179	63486725
Necrotising colitis	52.13	43.91	10	2108	593	63486311

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FDA Adverse Event Reporting System (Male)

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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
Status epilepticus	143.01	34.92	44	1742	12570	34942575
Drug ineffective	112.86	34.92	126	1660	456625	34498520
Seizure	58.73	34.92	46	1740	104811	34850334
Rhabdomyolysis	54.24	34.92	37	1749	68126	34887019
Nystagmus	43.17	34.92	14	1772	4701	34950444
Cardiac arrest	42.91	34.92	37	1749	96122	34859023
Propofol infusion syndrome	37.93	34.92	9	1777	957	34954188
Multiple-drug resistance	37.79	34.92	13	1773	5226	34949919
Drug ineffective for unapproved indication	37.39	34.92	20	1766	23695	34931450

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FDA Adverse Event Reporting System (Geriatric)

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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
Status epilepticus	275.52	32.83	84	3713	24957	79715634
Drug ineffective	254.62	32.83	281	3516	1080632	78659959
Multiple-drug resistance	124.88	32.83	36	3761	8772	79731819
Drug ineffective for unapproved indication	88.85	32.83	45	3752	51193	79689398
Seizure	87.31	32.83	72	3725	188762	79551829
Macroglossia	80.19	32.83	17	3780	1164	79739427
Nystagmus	70.86	32.83	24	3773	9880	79730711
Oropharyngeal oedema	70.46	32.83	13	3784	433	79740158
Drug reaction with eosinophilia and systemic symptoms	68.67	32.83	41	3756	64203	79676388
Hepatic function abnormal	66.27	32.83	42	3755	73065	79667526

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N03AB05	NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Hydantoin derivatives
FDA EPC	N0000175753	Anti-epileptic Agent
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	D049990	Membrane Transport Modulators
MeSH PA	D026941	Sodium Channel Blockers

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Drug Use | Suggest Off label Use Form| |View source of the data|

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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

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🐶 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:

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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	Q14524	SCN5A_HUMAN	BLOCKER				DRUGBANK	CHEMBL

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External reference:

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ID	Source
006181	NDDF
006182	NDDF
108397000	SNOMEDCT_US
117573	MMSL
134860	RXNORM
372484000	SNOMEDCT_US
386843000	SNOMEDCT_US
4020973	VANDF
4024030	VUID
4024030	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
CEREBYX	HUMAN PRESCRIPTION DRUG LABEL	1	0069-5471	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	28 sections
CEREBYX	HUMAN PRESCRIPTION DRUG LABEL	1	0069-5471	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	28 sections
CEREBYX	HUMAN PRESCRIPTION DRUG LABEL	1	0069-5474	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	28 sections
CEREBYX	HUMAN PRESCRIPTION DRUG LABEL	1	0069-5474	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	28 sections
CEREBYX	HUMAN PRESCRIPTION DRUG LABEL	1	0069-6001	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	27 sections
CEREBYX	HUMAN PRESCRIPTION DRUG LABEL	1	0069-6001	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	27 sections
Fosphenytoin	HUMAN PRESCRIPTION DRUG LABEL	1	63323-403	INJECTION, SOLUTION	50 mg	INTRAMUSCULAR	ANDA	32 sections
Fosphenytoin	HUMAN PRESCRIPTION DRUG LABEL	1	63323-403	INJECTION, SOLUTION	50 mg	INTRAMUSCULAR	ANDA	32 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

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