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Cenobamate Dosage

Medically reviewed by Drugs.com. Last updated on Jun 2, 2020.

Applies to the following strengths: 50 mg; 100 mg; 250 mg daily-dose; 350 mg daily-dose; 150 mg; 200 mg; 12.5 mg-25 mg; 50 mg-100 mg; 150 mg-200 mg

Usual Adult Dose for Seizures

Initial dose: 12.5 mg orally once a day for weeks 1 and 2
Titration: 25 mg orally once a day for weeks 3 and 4; 50 mg orally once a day for weeks 5 and 6; 100 mg orally once a day for weeks 7 and 8; 150 mg orally once a day for weeks 9 and 10
Maintenance Dose (starting at week 11): 200 mg orally once a day
Maximum Dose: 400 mg orally once a day

Comments:
-This drug may be used as monotherapy or as adjunctive therapy.
-Dosage and titration should not be exceeded because of the potential for serious adverse reactions.
-Titration to the maximum dose should be accomplished in increments of 50 mg/day every 2 weeks; the decision to increase the dose above the maintenance dose should be based on clinical response and tolerability.

Use: For the treatment of partial-onset seizures.

Renal Dose Adjustments

Mild to severe renal impairment: Use caution; dose reduction may be considered
ESRD undergoing dialysis: Not recommended

Liver Dose Adjustments

Mild to moderate hepatic impairment (Child-Pugh, Class A or B): Maximum dose: 200 mg/day; although additional dosage reduction may be needed
Severe hepatic impairment: Use is not recommended

Dose Adjustments

Geriatrics: Dose selection should be cautious, usually starting at the low end of the dosing range

Discontinuation of Therapy:
-Discontinue gradually over a period of at least 2 weeks, unless safety concerns require abrupt withdrawal

Precautions

CONTRAINDICATIONS:
-Hypersensitivity to this drug or any of the inactive ingredients
-Familial Short QT syndrome

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Pending Controlled Substance Scheduling

Dialysis

Not recommended

Other Comments

Administration advice:
-Take orally once a day; may take any time of day with or without food
-Swallow tablets whole with liquid; do not crush or chew

General:
-A DEA decision to schedule this drug is pending; a statement about abuse and dependence risks cannot be completed at this time.

Monitoring:
-Monitor for changes in mood or behavior including emergence or worsening of depression, suicidal thoughts, or thoughts of self-harm.

Patient advice:
-Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
-Patients should be instructed to avoid stopping this drug abruptly unless instructed to do so by their healthcare provider.
-Patients should be instructed to report a fever or rash associated with signs of other organ system involvement (e.g., lymphadenopathy, hepatic dysfunction); this drug should be discontinued immediately if a serious hypersensitivity reaction is suspected.
-Patients should be instructed to report prolonged heart palpitations or loss of consciousness.
-Patients should be instructed to report any changes in mood or behavior including emergence or worsening of depression, suicidal thoughts, or thoughts of self-harm.
-Patients should understand that this drug may cause somnolence, fatigue, dizziness, and gait disturbances as well as blurred vision or diplopia; patients should be instructed to avoid hazardous tasks until they know how this drug affects them.
-Women who are pregnant or intending to become pregnant should consult with their healthcare provider; women of reproductive potential should understand that this drug may decrease the efficacy of oral contraceptives and they should use additional or alternative non-hormonal birth control.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.