PHENYTOIN
Phenytoin is an anti-epileptic agent indicated for the management of specific seizure types and for seizure control in surgical settings. It is used to treat generalized tonic-clonic and complex partial seizures. Additionally, the medication is administered to prevent and treat seizures that occur during or after neurosurgical procedures.
How PHENYTOIN Works
While the exact therapeutic mechanism of phenytoin is not fully established, it is believed to function through the voltage-dependent blockade of membrane sodium channels. By targeting these channels, the drug reduces sustained high-frequency neuronal discharges in the brain. This stabilization of neuronal activity helps manage and prevent seizure activity.
Details
- Status
- Prescription
- First Approved
- 1992-09-25
- Routes
- ORAL
- Dosage Forms
- TABLET, CHEWABLE, SUSPENSION
PHENYTOIN Approval History
What PHENYTOIN Treats
3 indicationsPHENYTOIN is approved for 3 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Generalized Tonic-Clonic Seizures
- Complex Partial Seizures
- Seizures
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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.
PHENYTOIN FDA Label Details
ProIndications & Usage
Phenytoin chewable tablets are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin chewable tablets are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.