Drug Detail:Eslicarbazepine (Eslicarbazepine [ es-li-kar-baz-e-peen ])
Drug Class: Dibenzazepine anticonvulsants
Usual Adult Dose for Epilepsy
Initial dose: 400 mg orally once a day
- Treatment may be initiated at 800 mg orally once a day if needed (i.e., need for seizure reduction outweighs an increased risk of adverse reactions)
Maintenance dose: 800 to 1600 mg orally once a day
Comments:
- For use as monotherapy or as adjunctive therapy.
- Dose adjustments should be based on efficacy and tolerability.
- This drug should not be used as adjunctive therapy with oxcarbazepine.
Use: For the treatment of partial-onset seizures.
Usual Adult Dose for Seizures
Initial dose: 400 mg orally once a day
- Treatment may be initiated at 800 mg orally once a day if needed (i.e., need for seizure reduction outweighs an increased risk of adverse reactions)
Maintenance dose: 800 to 1600 mg orally once a day
Comments:
- For use as monotherapy or as adjunctive therapy.
- Dose adjustments should be based on efficacy and tolerability.
- This drug should not be used as adjunctive therapy with oxcarbazepine.
Use: For the treatment of partial-onset seizures.
Usual Pediatric Dose for Epilepsy
4 years or older:
Weight: 11 to 21 kg:
Initial dose: 200 mg orally once a day
- Increase in increments no greater than 200 mg/day per week
Weight: 22 to 31 kg:
Initial dose: 300 mg orally once a day
- Increase in increments no greater than 300 mg/day per week
Weight: 32 to 38 kg:
Initial dose: 300 mg orally once a day
- Increase in increments no greater than 300 mg/day per week
Greater than 38 kg:
Initial dose: 400 mg orally once a day
- Increase in increments no greater than 400 mg/day per week
Comments:
- For use as monotherapy or as adjunctive therapy.
- Dose adjustments should be based on efficacy and tolerability.
- This drug should not be used as adjunctive therapy with oxcarbazepine.
Use: For the treatment of partial-onset seizures in patients 4 years of age and older
Usual Pediatric Dose for Seizures
4 years or older:
Weight: 11 to 21 kg:
Initial dose: 200 mg orally once a day
- Increase in increments no greater than 200 mg/day per week
Weight: 22 to 31 kg:
Initial dose: 300 mg orally once a day
- Increase in increments no greater than 300 mg/day per week
Weight: 32 to 38 kg:
Initial dose: 300 mg orally once a day
- Increase in increments no greater than 300 mg/day per week
Greater than 38 kg:
Initial dose: 400 mg orally once a day
- Increase in increments no greater than 400 mg/day per week
Comments:
- For use as monotherapy or as adjunctive therapy.
- Dose adjustments should be based on efficacy and tolerability.
- This drug should not be used as adjunctive therapy with oxcarbazepine.
Use: For the treatment of partial-onset seizures in patients 4 years of age and older
Renal Dose Adjustments
Mild renal impairment: No adjustment recommended
Moderate to severe renal impairment (CrCl less than 50 mL/min: Initial, titration, and maintenance doses should generally be reduced by 50%; adjust doses based on clinical response
Liver Dose Adjustments
Mild to moderate liver impairment: No adjustment recommended.
Severe liver impairment: Not recommended
Dose Adjustments
Drug Discontinuation:
- The dosage should be reduced gradually to minimize the risk of increased seizure frequency and status epilepticus.
Concomitant Use with Other Antiepileptic Drugs (AEDs):
- Concomitant use of carbamazepine reduces the plasma concentration of this drug and increases the frequency of adverse reactions; when used concomitantly, the dose of this drug or carbamazepine may need to be adjusted based on efficacy and tolerability
- Concomitant use of other enzyme-inducing AEDs (e.g., primidone, phenytoin, phenobarbital) may require higher doses of this drug
This drug should not be taken as adjunctive therapy with oxcarbazepine
Precautions
CONTRAINDICATIONS
- Hypersensitivity to eslicarbazepine or oxcarbazepine
Safety and efficacy have not been established in patients younger than 4 years.
Consult WARNINGS section for additional precautions.
Dialysis
Standard hemodialysis procedures result in partial clearance of this drug
Other Comments
Administration advice:
- Take orally once a day without regard to meals
- Swallow whole; may divide or crush if needed
General:
- This drug may be used as monotherapy or adjunctive therapy for the treatment of partial-onset seizures.
Monitoring:
- Monitor sodium concentrations, especially in patients taking other medications that can lower sodium
- Monitor for skin reactions
- Monitor for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm
Patient advice:
- Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
- Patients should be advised against engaging in hazardous activities requiring mental alertness until the effects of this drug are known.
- Patients/caregivers should be advised to promptly report the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm; skin reactions, symptoms of low sodium; and/or symptoms suggestive of blood disorders.
- Patients/caregivers should be advised against abrupt discontinuation of therapy.
- Women of childbearing potential should receiving counseling on AEDs effects on pregnancy. the potential interaction of this drug with oral contraceptives and the need for additional or alternative non-hormonal birth control.
