Clinical beta

FMBM is currently in clinical beta. Content is for professional review/testing and must not replace local protocols, senior clinical judgment, or official prescribing references.

Drug Monograph

USE IF: Seizure disorders, status epilepticus (second-line after benzodiazepines)

AVOID IF: Severe cardiac conduction abnormalities, hypersensitivity, unsafe IV administration setting

Phenytoin

Antiepileptic (voltage-gated sodium channel blocker)

AdultPediatricNeurologyERICUHigh-yield

Indication

Seizures • Status epilepticus (second-line)

At a glance

INDICATIONS (CORE USE)

- Seizure disorders - Status epilepticus (after benzodiazepines)

ADULT DOSE (STANDARD)

IV loading dose followed by maintenance dosing Adjust using serum levels and clinical response

MAX DOSE

Protocol-based; constrained by toxicity risk and therapeutic levels

Route

IV • PO

PEDIATRIC DOSE

Protocol-based

Do not miss

Must-not-miss safety points

Major warning

- IV infusion can cause hypotension and arrhythmias - Purple glove syndrome risk with extravasation - Narrow therapeutic window requires level-guided dosing - Nonlinear kinetics: small dose changes can cause large level shifts - Strong enzyme induction causes major interaction burden

Institutional protocol required

Dosing for this medication is not a substitute for your hospital order set, pharmacy verification, or specialty protocol. Use only with an approved institutional pathway, continuous monitoring, and independent double-check where policy requires.

FMBM beta: decision support only — not medical advice or a prescribing system.

Indications

INDICATION: Seizures • Status epilepticus (second-line)

Primary

  • Seizure disorders
  • Status epilepticus (second-line)

Institutional protocol required

Dosing for this medication is not a substitute for your hospital order set, pharmacy verification, or specialty protocol. Use only with an approved institutional pathway, continuous monitoring, and independent double-check where policy requires.

Numeric examples in this monograph are illustrative only when present — always follow your verified institutional protocol and product labeling.

FMBM beta: decision support only — not medical advice or a prescribing system.

Dosing

STANDARD (ADULT PO)

IV loading in acute settings, then maintenance dosing adjusted by level and response

ADULT DOSE

STANDARD (ADULT): - IV loading in acute settings - Maintenance dosing adjusted by serum levels and clinical response

PEDIATRIC DOSE

Protocol-based

MAX DOSE

No single universal max; toxicity and concentrations guide practical ceilings

Practical Note

- Monitor levels due to nonlinear kinetics - Avoid rapid dose escalation - IV administration must follow strict rate limits

Warnings

Clinical warnings

  • Use only with an approved institutional order set and pharmacy verification — this monograph is clinical decision support, not standalone prescribing authority.
  • Cardiac toxicity during IV administration
  • Hypotension
  • CNS toxicity (nystagmus, ataxia, confusion)
  • Gingival hyperplasia with chronic use
  • Severe skin reactions (rare)

Adverse effects

  • Nystagmus
  • Ataxia
  • Sedation
  • Rash

Contraindications

  • Sinus bradycardia or significant conduction abnormalities
  • Known hypersensitivity

Drug interactions

  • Strong enzyme inducer that can reduce levels/effects of many drugs
  • Other antiepileptics create complex bidirectional level interactions
  • Warfarin exposure and INR can be altered

Special populations

Pediatrics

Protocol-based

Pregnancy

Pregnancy: Use only when maternal seizure control benefit outweighs fetal risk and follow specialist protocol

Lactation

Use with monitoring as clinically indicated.

Renal impairment

Interpret total levels cautiously in hypoalbuminemia/renal disease; free level assessment may be needed in selected cases.

Hepatic impairment

Hepatic metabolism is affected in liver dysfunction; monitor closely and titrate cautiously.

Elderly

Increased CNS sensitivity and toxicity risk; use cautious titration and close monitoring.

Administration

- IV: slow infusion only (follow rate limits) - Continuous cardiac monitoring required during IV loading - Avoid extravasation

Monitoring

  • Monitor: - Serum levels - CNS status - Cardiac status during IV use
  • Recheck: - After dose changes - Periodically during therapy
  • Hold / reassess: - Toxic levels - Arrhythmia or hypotension - Severe CNS toxicity

Overdose / toxicity

Clinical Picture

CNS depression, ataxia, nystagmus, and cardiac toxicity (particularly with IV exposure)

Immediate Actions

Supportive care with continuous cardiac monitoring

Antidote

None specific

Decontamination

Supportive toxicology-directed management

Escalation

Escalate to critical care for hemodynamic instability, arrhythmia, or severe neurologic depression

Clinical pearls

Common mistakes, resistance logic, and bedside traps

High-Yield

  • Second-line for status epilepticus after benzodiazepines
  • Requires serum level monitoring

Clinical

  • Nonlinear kinetics require cautious dose changes and reassessment

Safety

  • Most dangerous error is rapid IV infusion

Pharmacy Tool

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Phenytoin 10 mg/mL oral solution

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Pharmacokinetics

- Nonlinear (saturable) metabolism - Hepatic metabolism - Highly protein-bound

Mechanism of action

- Sodium channel blockade stabilizes neuronal firing

Common brand names

Saudi Arabia

Epanutin, Dilantin

Global

Phenytoin, Dilantin (example), (placeholder — verify local formulation)

Common trade names are curated examples only — formulations and availability vary. Verify the exact product name with your local pharmacy and national regulator before prescribing or dispensing.

Country practice notes

Global data (no country-specific data available)

  • Follow local antimicrobial stewardship policy, hospital formulary, and national resistance guidance.
  • Confirm dosing, stock, and restrictions with institutional pharmacy and current product labeling.

References

Saudi Arabia

  • SFDA (Saudi Food & Drug Authority)
  • Saudi National Formulary / MOH (where available)

International

  • WHO Model List of Essential Medicines (verify current edition)
  • US FDA or EU EMA product information (when national SmPC is unavailable)
  • Product labeling (phenytoin)
  • Local status epilepticus and therapeutic drug monitoring protocols