DILANTIN-125
Dilantin-125 (phenytoin) is an anti-epileptic agent indicated for the management of specific seizure disorders. It is used to treat patients experiencing tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. The medication serves as a therapeutic intervention to control these neurological conditions.
How DILANTIN-125 Works
The therapeutic effect of phenytoin is thought to involve the voltage-dependent blockade of membrane sodium channels. By targeting these channels, the drug results in a reduction of sustained high-frequency neuronal discharges. This stabilization of neuronal activity helps prevent the excessive electrical firing associated with seizures.
Details
- Status
- Prescription
- First Approved
- 1953-01-06
- Routes
- ORAL
- Dosage Forms
- SUSPENSION
DILANTIN-125 Approval History
What DILANTIN-125 Treats
2 indicationsDILANTIN-125 is approved for 2 conditions since its original approval in 1953. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Tonic-Clonic Seizures
- Psychomotor Seizures
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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.
DILANTIN-125 FDA Label Details
ProIndications & Usage
FDA Label (PDF)DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.