FOSPHENYTOIN SODIUM
FOSPHENYTOIN SODIUM is indicated for the treatment of Generalized tonic-clonic status epilepticus; Prevention and treatment of seizures occurring during neurosurgery; Short-term substitution for oral phenytoin when oral administration is not possible.
How FOSPHENYTOIN SODIUM Works
Fosphenytoin is a prodrug that is converted into phenytoin to exert its anticonvulsant effects. It is thought to work through the voltage-dependent blockade of sodium channels in neuronal membranes. This action results in a reduction of sustained high-frequency neuronal discharges, which helps stabilize electrical activity in the brain.
Details
- Status
- Prescription
- First Approved
- 2007-08-06
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
FOSPHENYTOIN SODIUM Approval History
What FOSPHENYTOIN SODIUM Treats
3 indicationsFOSPHENYTOIN SODIUM is approved for 3 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Generalized tonic-clonic status epilepticus
- Prevention and treatment of seizures occurring during neurosurgery
- Short-term substitution for oral phenytoin when oral administration is not possible
FOSPHENYTOIN SODIUM Boxed Warning
CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION RATES The rate of intravenous fosphenytoin sodium injection administration should not exceed 150 mg phenytoin sodium equivalents (PE) per minute in adults and 2 mg PE/kg/min (or 150 mg PE/min, whichever is slower) in pediatric patients because of the risk of severe hypotension and cardiac arrhythmias. Careful cardiac monitoring is needed during and after administering intravenous fosphenytoin sodium injection. Although the risk of cardiovascular...
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION RATES The rate of intravenous fosphenytoin sodium injection administration should not exceed 150 mg phenytoin sodium equivalents (PE) per minute in adults and 2 mg PE/kg/min (or 150 mg PE/min, whichever is slower) in pediatric patients because of the risk of severe hypotension and cardiac arrhythmias. Careful cardiac monitoring is needed during and after administering intravenous fosphenytoin sodium injection. Although the risk of cardiovascular toxicity increases with infusion rates above the recommended infusion rate, these events have also been reported at or below the recommended infusion rate. Reduction in rate of administration or discontinuation of dosing may be needed [see Dosage and Administration ( 2.3 , 2.4 ) and Warnings and Precautions ( 5.2 )]. WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION RATES See full prescribing information for complete boxed warning. The rate of intravenous fosphenytoin sodium administration should not exceed 150 mg phenytoin sodium equivalents (PE) per minute in adults and 2 mg PE/kg/min (or 150 mg PE/min, whichever is slower) in pediatric patients because of the risk of severe hypotension and cardiac arrhythmias. Careful cardiac monitoring is needed during and after administering intravenous fosphenytoin sodium. Reduction in rate of administration or discontinuation of dosing may be needed ( 2.3 , 2.4 , 5.2 ) .
FOSPHENYTOIN SODIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to FOSPHENYTOIN SODIUM
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FOSPHENYTOIN SODIUM FDA Label Details
Indications & Usage
FDA Label (PDF)FOSPHENYTOIN SODIUM is indicated for the treatment of Generalized tonic-clonic status epilepticus; Prevention and treatment of seizures occurring during neurosurgery; Short-term substitution for oral phenytoin when oral administration is not possible.
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION RATES The rate of intravenous fosphenytoin sodium injection administration should not exceed 150 mg phenytoin sodium equivalents (PE) per minute in adults and 2 mg PE/kg/min (or 150 mg PE/min, whichever is slower) in pediatric patients beca...
Looking for the branded version?
CEREBYX
Full clinical data, patents, trials, and competitive landscape for fosphenytoin sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.