Drug Guide
Cenobamate
Classification
Therapeutic: Anticonvulsant/Anti-epileptic
Pharmacological: GABA-modulating agent
FDA Approved Indications
- Partial-onset seizures in adults
Mechanism of Action
Cenobamate enhances GABAergic inhibitory transmission and inhibits voltage-gated sodium channels, reducing neuronal excitability.
Dosage and Administration
Adult: Start at 12.5 mg once daily, titrate slowly by 12.5–25 mg/week to a target dose of 200 mg/day based on response and tolerability.
Pediatric: Not approved for pediatric use.
Geriatric: Start at lower doses, titrate cautiously due to increased susceptibility to adverse effects.
Renal Impairment: Use with caution; no specific dose adjustment recommended, but monitor closely.
Hepatic Impairment: Use with caution; no specific dose adjustment recommended, but consider liver function tests.
Pharmacokinetics
Absorption: Well-absorbed orally.
Distribution: Widely distributed, crosses blood-brain barrier.
Metabolism: Primarily metabolized in the liver via glucuronidation and oxidation, involving CYP2E1 and other enzymes.
Excretion: Excreted mainly in urine (via metabolites), small amount unchanged in feces.
Half Life: Approximately 50 hours, allowing once-daily dosing.
Contraindications
- Hypersensitivity to cenobamate or components.
- History of hypersensitivity reactions.
Precautions
- Monitor for hypersensitivity, including skin reactions and eosinophilia-associated syndromes; avoid in patients with certain seizure types until more data available.
Adverse Reactions - Common
- Sedation or fatigue (Common)
- Dizziness (Common)
- Headache (Common)
- Nausea (Common)
Adverse Reactions - Serious
- DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) leading to progression of severe skin reactions, hepatotoxicity, and hematologic abnormalities. (Rare but serious.)
Drug-Drug Interactions
- Concomitant use with other central nervous system depressants may increase sedation.
- Cenobamate may alter the metabolism of other drugs metabolized by CYP2C19 and CYP3A4.
Drug-Food Interactions
- No significant food interactions identified.
Drug-Herb Interactions
- Limited data; consult current resources.
Nursing Implications
Assessment: Monitor seizure frequency, neurological status, liver function tests, and skin for signs of serious adverse reactions.
Diagnoses:
- Ineffective airway clearance related to seizures, risk of injury related to adverse effects.
Implementation: Administer as prescribed, titrate doses carefully, and educate about adherence and side effect monitoring.
Evaluation: Assess seizure control and adverse reactions, including skin reactions and liver function periodically.
Patient/Family Teaching
- Take medication exactly as prescribed.
- Report any signs of rash, allergic reactions, or unusual symptoms immediately.
- Avoid alcohol and CNS depressants unless approved by the healthcare provider.
- Do not discontinue abruptly.
Special Considerations
Black Box Warnings:
- Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, can occur.
- Hepatotoxicity is possible; liver function should be monitored.
- Potential for interactions affecting other medications.
Genetic Factors: Genetic variations in enzymes involved in drug metabolism may influence individual response.
Lab Test Interference: No specific interference reported.
Overdose Management
Signs/Symptoms: Dizziness, somnolence, ataxia, agitation, or loss of consciousness.
Treatment: Supportive care, monitor respiratory and cardiac function, activated charcoal if ingestion is recent, and maintain airway.
Storage and Handling
Storage: Store at room temperature, 20–25°C (68–77°F), protected from moisture and light.
Stability: Stable under recommended storage conditions.