Eslicarbazepine acetate oral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of eslicarbazepine acetate.
Epilepsy (newly diagnosed) - partial seizures: monotherapy
Epilepsy-partial seizures with/without secondary generalisation-adjunctive
Recommended initial dose is 400mg once a day. This should be increased to 800mg once daily after 1 or 2 weeks.
The dose may be increased to 1.2g once a day, based on individual response.
The dose for monotherapy treatment may be increased to 1.6g once a day, based on individual response.
As for adults, however in monotherapy the recommended maximum dose is 1.2g once a day.
Children aged 6 to 18 years with a body weight below 60kg
Recommended initial dose is 10mg/kg once a day. This can be increased by 10mg/kg/day increments, every 1 to 2 weeks up to 30mg/kg/day. The maximum dose should not exceed 1.2g once a day.
Children aged 6 to 18 years with body weight equal to or greater than 60kg
(See Dosage; Adult)
Patients with Renal Impairment
Creatinine clearance 30ml/minute to 60ml/minute
Initial dose: 200mg (or 5mg/kg in children aged 6 to 18 years) once a day or 400mg (or 10mg/kg in children aged 6 to 18 years) every other day for 2 weeks followed by a once a day dose of 400mg (or 10mg/kg in children aged 6 years to 18 years). However, based on individual response, the dose may be increased.
Additional Dosage Information
Switching between tablet and oral suspension formulations may be done with caution if necessary.
Children under 6 years
Renal impairment - creatinine clearance below 30 ml/minute
Second degree atrioventricular block
Severe hepatic impairment
Third degree atrioventricular block
Precautions and Warnings
East Asian ancestry
Patients over 65 years
Predisposition to hyponatraemia
Cardiac conduction defects
Mild hepatic impairment
Reduce dose in patients with creatinine clearance of 30-60ml/min
Advise ability to drive/operate machinery may be affected by side effects
Confirm HLA-B 1502 status in Han Chinese & Thai patients before initiating
Consider prescribing by manufacturer to ensure seizure control maintenance
Folic acid 5mg daily required pre-conception to end of 1st trimester
Oral liquid contains hydroxybenzoate: caution in hypersensitivity
May prolong PR interval
Monitor for signs of suicide ideation or behaviour
Monitor plasma sodium in patients at risk of hyponatraemia
Refer women considering pregnancy for specialist advice and monitoring
Advise patient to seek medical advice if severe skin reaction occurs
Avoid abrupt withdrawal
Discontinue if hypersensitivity reactions occur
Discontinue if severe skin reaction occurs
Discontinue immediately if hyponatraemia occurs
Female: Ensure adequate contraception during treatment
Advise if swallowing difficult may be crushed and added to soft food/liquid
Advise patient/carers to report signs of suicide ideation or behaviour
Severe cutaneous adverse reactions (SCARS) including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. Advise patients of the signs and symptoms at treatment initiation and monitor closely. If the patient develops such reactions, treatment with eslicarbazepine must not be restarted at any time.
Patients who are HLA-B*1502 positive have a higher risk for SJS. Eslicarbazepine may only be used if the benefits are thought to outweigh the risks. In addition to Han Chinese and Thai patients, HLA-B*1502 may be present in other Asian populations and as such, screening should be considered in at risk patients.
The risk of serious dermatological adverse reactions including SJS occurring with carbamazepine and eslicarbazepine is potentially raised due to the HLA-A*3101 allele in patients of European or Japanese origin. However there is insufficient data to support screening of this allele before initiating treatment. Patients of European descent or Japanese origin who are known to be positive for this allele should only receive eslicarbazepine after a careful risk/benefit analysis.
For patients who are unable to swallow whole tablets, some of the manufacturers state that they may be crushed and mixed with soft foods, such as apple sauce or in liquids, immediately prior to use.
Pregnancy and Lactation
Use eslicarbazepine acetate with caution during pregnancy.
There is limited data from the use of eslicarbazepine acetate in pregnancy. Animal studies have shown reproductive toxicity. Extensive data shows a two to three times increased prevalence of malformations in the offspring of patients with epilepsy. The risk is further increased by the use of multiple antiepileptic drugs.
If women receiving eslicarbazepine acetate become pregnant or plan to become pregnant the use of eslicarbazepine acetate should be re-evaluated. Treatment must not be abruptly discontinued. Minimum effective doses should be given, and monotherapy whenever possible should be preferred, particularly during the first 3 months of pregnancy. Patients should be counselled regarding the possibility of an increased risk of malformations and given the opportunity to antenatal screening. Vitamin K1 should be administered as a preventative measure in the last few weeks of pregnancy and to the neonate.
Specialist advice should be sought before using eslicarbazepine acetate in women desiring to become pregnant.
Eslicarbazepine acetate is contraindicated during breastfeeding.
The manufacturer recommends that breastfeeding should be discontinued during treatment. It is unknown whether eslicarbazepine is excreted in human breast milk, but animal studies have shown excretion in breast milk. The risks are unknown.
Eslicarbazepine may decrease the effectiveness of oral contraceptives. Women should be advised to use additional non-hormonal forms of contraception during use and until the first menstruation after eslicarbazepine is discontinued.
Advise ability to drive or operate machinery may be affected by side effects.
Advise patients/carers to report signs of suicidal ideation or behaviour.
Inform patients of the signs of severe cutaneous adverse reactions (SCARS).
Advise patients considering pregnancy that specialist referral for advice and monitoring is required.
Blood pressure changes
Decrease in haemoglobin and haematocrit
Disturbances of appetite
Drug rash with eosinophilia and systemic symptoms (DRESS)
Increase in serum transaminases
Loss of balance
Metabolic bone disease
Toxic epidermal necrolysis
Urinary tract infections
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: January 2019
Summary of Product Characteristics: Arupsan 200mg tablets. Accord Healthcare Limited. Revised May 2021.
Summary of Product Characteristics: Arupsan 800mg tablets. Accord Healthcare Limited. Revised May 2021.
Summary of Product Characteristics: Zebinix 200mg and 800mg tablets. Eisai Ltd. Revised April 2020.
Summary of Product Characteristics: Zebinix 50mg/ml oral suspension. Eisai Ltd. Revised March 2019.
MHRA Drug Safety Update August 2008
Available at: https://www.mhra.gov.uk
Last accessed: 09 January 2019
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 18 January 2022
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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