Cenobamate — Active Pharmaceutical Ingredient

Cenobamate is an active pharmaceutical ingredient found in 2 FDA-approved drug products. Forms: TABLET. Routes: ORAL.

This content is for informational purposes only. Always consult a healthcare professional.

Cenobamate (2 brand names, 1 dosage form, 1 route)

Available dosage forms: TABLET.

Routes of administration: ORAL.

Brand Names

  • CENOBAMATE
  • XCOPRI

Indications and Usage

XCOPRI is indicated for the treatment of partial-onset seizures in adult patients.

Contraindications

XCOPRI is contraindicated in patients with: Hypersensitivity to cenobamate or any of the inactive ingredients in XCOPRI [see Warnings and Precautions (5.1) and Description (11)] Familial Short QT syndrome [see Warnings and Precautions (5.2)]

Adverse Reactions

The following serious adverse reactions are described in more detail in the Warnings and Precautions section of the labeling: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.1)] QT Shortening [see Warnings and Precautions (5.2)] Suicidal Behavior and Ideation [see Warnings and Precautions (5.3)] Liver Injury [see Warnings and Precautions (5.4)] Neurological Adverse Reactions [see Warnings and Precautions (5.5)] Withdrawal of Antiepileptic Drugs [see Warnings and Precautions (5.6)]

Mechanism of Action

The precise mechanism by which cenobamate exerts its therapeutic effects in patients with partial-onset seizures is unknown. Cenobamate has been demonstrated to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel.

Overdosage

There is limited clinical experience with XCOPRI overdose in humans. There is no specific antidote for overdose with XCOPRI. In the event of overdose, standard medical practice for the management of any overdose should be used. An adequate airway, oxygenation and ventilation should be ensured; monitoring of cardiac rate and rhythm and vital signs is recommended. A certified poison control center should be contacted for updated information on the management of overdose with XCOPRI. There are no data on the removal of XCOPRI using dialysis.

⚠ Caution
Medical Disclaimer: This information is for educational purposes only. Always consult a healthcare professional before taking any medication.