PHENYTOIN

Anticonvulsant

Brand names: Phenytoin, Dilantin

Oral

Mechanism of Action

12.1 Mechanism of Action The precise mechanism by which phenytoin exerts its therapeutic effect has not been established but is thought to involve the voltage-dependent blockade of membrane sodium channels resulting in a reduction in sustained high-frequency neuronal discharges.

Indications

1 INDICATIONS AND 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. ( 1 )

Contraindications

• 4 CONTRAINDICATIONS Phenytoin chewable tablets are contraindicated in patients with: • A history of hypersensitivity to phenytoin
• its inactive ingredients
• its ingredients
• or other hydantoins ( 4
• 5.5 ) • A history of prior acute hepatotoxicity attributable to phenytoin ( 4

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Withdrawal Precipitated Seizure: May precipitate status epilepticus
2 ) • Serious Dermatologic Reactions: Discontinue phenytoin chewable tablets at the first sign of a rash, unless the rash is clearly not drug-related
2 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including phenytoin chewable tablets, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication
Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1

Known Side Effects

8 documented side effects by frequency

Drug Not Working

>10%

Falls

1-10%

Dizziness

1-10%

Headache

0.1-1%

Nausea

0.1-1%

Fatigue

0.1-1%

Fever

0.1-1%

Rash

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral