Cenobamato|Apilepsy|HongKong DengYue Medicine

  • Generic Name/Brand Name: Cenobamato / XCOPRI (U.S.), Ontozry (EU)
  • Indications: Treatment of partial-onset seizures in adults.
  • Dosage Form: Film-coated tablets for oral administration.
  • Specification: 12.5 mg, 25 mg, 50 mg, 100 mg, and 200 mg.

Cenobamato Application Scope

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

cenobamato

Cenobamato Characteristics

  • Ingredients: Active ingredient: Cenobamato.

  • Properties: Cenobamato is a novel antiepileptic drug that acts by blocking voltage-gated sodium channels and enhancing GABAergic neurotransmission, thereby reducing neuronal excitability.

  • Specification: Available in tablet form with strengths of 12.5 mg, 25 mg, 50 mg, 100 mg, and 200 mg.

  • Packaging Specification: Supplied in blister packs or bottles, depending on the dosage and quantity.

  • Storage: Store at room temperature, between 20°C to 25°C (68°F to 77°F).

  • Expiry Date: Refer to the packaging for the specific expiration date.

  • Executive Standard: Approved by the U.S. Food and Drug Administration (FDA) under NDA 212839.

  • Approval Number: NDA 212839.

  • Date of Revision: Refer to the latest prescribing information for the most recent revision date.

  • Manufacturer: SK Life Science, Inc.

Guidelines For The Use Of Cenobamato

  • Dosage and Administration:

    • Initiate treatment at 12.5 mg once daily.

    • Titrate the dose every two weeks as follows:

      • Week 1–2: 12.5 mg once daily

      • Week 3–4: 25 mg once daily

      • Week 5–6: 50 mg once daily

      • Week 7–8: 100 mg once daily

      • Week 9–10: 150 mg once daily

      • Week 11 and thereafter: 200 mg once daily

    • If needed, the dose may be increased above 200 mg by increments of 50 mg once daily every two weeks to a maximum of 400 mg once daily, based on clinical response and tolerability.

  • Adverse Reactions:

    • Common adverse reactions include somnolence, dizziness, fatigue, diplopia, and headache.

    • Serious adverse reactions may include Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

  • Contraindications:

    • Cenobamato is contraindicated in patients with familial short QT syndrome.

  • Precautions:

    • Use caution in patients with hepatic or renal impairment.

    • Monitor for signs of hypersensitivity reactions.

    • Advise patients to avoid operating machinery or driving until they know how Cenobamato affects them.

Cenobamato Interactions

  • Drug Interactions:

    • Cenobamato may decrease the effectiveness of hormonal contraceptives; alternative non-hormonal contraceptive methods are recommended.

    • May increase plasma concentrations of phenytoin and phenobarbital; dose adjustments may be necessary.

    • May decrease plasma concentrations of drugs metabolized by CYP3A4 and CYP2B6 (e.g., midazolam, bupropion).

    • May increase plasma concentrations of drugs metabolized by CYP2C19 (e.g., omeprazole).

 

Note:

  • If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
  • It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.
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