Cenobamate Dosage

Medically reviewed by Drugs.com. Last updated on Nov 18, 2024.

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

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Precautions
Dialysis
Other Comments

Usual Adult Dose for Seizures

INITIAL DOSE:

Weeks 1 and 2: 12.5 mg orally once a day

TITRATION:

Weeks 3 and 4: 25 mg orally once a day
Weeks 5 and 6: 50 mg orally once a day
Weeks 7 and 8: 100 mg orally once a day
Weeks 9 and 10: 150 mg orally once a day

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.
Dose selection in older patients should be cautious and start at the lower end of the dosing range.
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 (CrCl less than 90 mL/min): Use caution; dose reduction may be considered
ESRD undergoing dialysis: Not recommended

Liver Dose Adjustments

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

Dose Adjustments

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.

US Controlled Substance: V

Dialysis

Not recommended.

Other Comments

Administration advice:

For oral or nasogastric administration
Administer dose at any time of day, with or without food.
Tablets can be swallowed whole or crushed.
If crushing tablets, mix with water and administer by mouth as an oral suspension or via nasogastric tube; refer to the manufacturer product information for complete instructions.

Storage requirements:

Store tablets at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
Suspension for oral or nasogastric use: Administer immediately; cannot be stored for future use.

General:

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry at http://www.aedpregnancyregistry.org/ or by calling 1-888-233-2334.

Monitoring:

Dermatologic: For skin reactions (during therapy)
Neurologic: For signs and symptoms of CNS depression such as somnolence, sedation, and fatigue (during therapy, especially with concomitant use of other drugs with sedative properties)
Psychiatric: For changes in mood or behavior including emergence or worsening of depression, suicidal thoughts, or thoughts of self-harm (during therapy)

Patient advice:

Read the US FDA-approved patient labeling (Medication Guide).
Avoid stopping this drug abruptly unless instructed to do so by their healthcare provider.
Report fever or rash associated with signs of other organ system involvement; this drug should be discontinued immediately if a serious hypersensitivity reaction is suspected.
Report prolonged heart palpitations or loss of consciousness.
Notify your health care provider about any changes in mood or behavior, including emergence or worsening of depression, suicidal thoughts, or thoughts of self-harm.
Avoid hazardous tasks, including driving or operating machinery, until the effects of this drug are known.
Women who are pregnant or intending to become pregnant: Consult your healthcare provider; a pregnancy registry is available to monitor outcomes in pregnant women taking this drug.
Women of reproductive potential: Use additional or alternative non-hormonal birth control to prevent pregnancy during therapy.