Phenytoin (100mg)

Clinical Pharmacologist's Monograph

⚠️ Prescription Only: This medicine is Schedule H/H1. Do not self-medicate.

1. Clinical Overview

Phenytoin is a first-generation hydantoin-derivative anticonvulsant, primarily used for the management of generalized tonic-clonic (grand mal) seizures and partial (focal) seizures. It is a non-sedative drug that stabilizes neuronal membranes by blocking voltage-gated sodium channels, thereby preventing the spread of seizure activity. It exhibits non-linear (Michaelis-Menten) pharmacokinetics, making therapeutic drug monitoring (TDM) crucial, especially in the Indian context where genetic polymorphisms in CYP2C9 and CYP2C19 can affect metabolism.

OnsetDurationBioavailability
Oral: 30 minutes to 2 hours; IV: Rapid, within minutes.Variable, typically 12-24 hours due to long half-life at therapeutic doses.Approximately 90% for oral formulations.

2. Mechanism of Action

Phenytoin exerts its primary anticonvulsant effect by use-dependent blockade of voltage-gated sodium channels in neurons. It preferentially binds to and stabilizes the inactivated state of the channel, preventing high-frequency repetitive firing of action potentials. This inhibits the spread of seizure activity from epileptogenic foci without affecting normal neuronal conduction.

3. Indications & Uses

  • Generalized tonic-clonic seizures (Grand mal epilepsy)
  • Complex partial (focal) seizures
  • Status epilepticus (using intravenous formulation)
  • Prophylaxis and treatment of seizures following neurosurgery or traumatic brain injury

4. Dosage & Administration

Adult Dosage: Loading dose: 15-20 mg/kg IV (for status) or orally divided (e.g., 400-600 mg/day for 1-2 days). Maintenance: Start 100 mg TDS (300 mg/day). Usual range: 200-400 mg/day. MUST be individualized based on TDM.

Administration: Oral: Take with or after food to minimize GI upset. Swallow whole, do not crush or chew capsules. Suspension must be shaken vigorously. DO NOT switch between brands/formulations without monitoring. IV: For status epilepticus, infuse slowly (<50 mg/min in adults) with cardiac monitoring. Incompatible with many IV solutions; use only with normal saline.

5. Side Effects

Common side effects may include:

  • Nystagmus (dose-related)
  • Ataxia, dizziness, slurred speech
  • Gingival hyperplasia (especially in children and young adults)
  • Hirsutism
  • Coarsening of facial features
  • Gastrointestinal discomfort
  • Mild cognitive impairment

6. Drug Interactions

DrugEffectSeverity
WarfarinPhenytoin increases warfarin metabolism (decreased INR). Warfarin can displace phenytoin from protein binding.Major
CarbamazepineMutual induction of metabolism, reducing levels of both drugs.Major
Valproic Acid / Sodium ValproateValproate displaces phenytoin from protein binding (increases free fraction) and inhibits its metabolism. Complex interaction requiring free phenytoin level monitoring.Major
PhenobarbitalMutual enzyme induction, variable effect.Moderate
Cimetidine, Omeprazole, FluconazoleInhibit phenytoin metabolism, increasing its levels.Major
Rifampicin, Antiretroviral drugsInduce phenytoin metabolism, decreasing its levels.Major
Oral Contraceptives, LevonorgestrelPhenytoin induces metabolism, reducing contraceptive efficacy. Advise alternative/barrier methods.Major
TheophyllinePhenytoin decreases theophylline levels.Moderate
Folic AcidFolic acid may decrease phenytoin levels.Moderate
Isoniazid (INH)Potent inhibitor of phenytoin metabolism; high risk of toxicity.Major

7. Patient Counselling

  • DO take the medicine at the same time(s) every day.
  • DO NOT stop the medicine suddenly; this can cause withdrawal seizures.
  • DO NOT change brands or switch between capsule and suspension without consulting your doctor.
  • DO practice excellent oral hygiene (brush, floss, regular dental check-ups) to minimize gingival hyperplasia.
  • DO inform all your doctors and dentists you are taking phenytoin.
  • DO carry a seizure/medical ID card.

8. Toxicology & Storage

Overdose: Primarily CNS: Nystagmus, ataxia, slurred speech, lethargy progressing to coma. Cerebellar signs are prominent. At very high levels: Hypotension, bradycardia, cardiac arrest, respiratory depression. Death is usually from respiratory and circulatory depression.

Storage: Store at room temperature (15-30°C) in a dry place, protected from light. Keep the container tightly closed. Do not freeze. Keep out of reach of children. Suspension: Shake well before each use. Do not use if suspension is discolored or contains particles.