Drug reference

Eslicarbazepine acetate

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 351, 352

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

Monotherapy of focal seizures with or without secondary generalisation ▶BY MOUTH ▶Adult: Initially 400 mg once daily for 1–2 weeks, then increased to 800 mg once daily, then increased if necessary to 1.2 g once daily (max. per dose 1.6 g) ▶Elderly: Initially 400 mg once daily for 1–2 weeks, then increased to 800 mg once daily (max. per dose 1.2 g) Adjunctive therapy of focal seizures with or without secondary generalisation ▶BY MOUTH ▶Adult: Initially 400 mg once daily for 1–2 weeks, then increased to 800 mg once daily (max. per dose 1.2 g)

PDF page 351

Contra Indications

Second- or third-degree AV block

PDF page 351

Cautions

Elderly. hyponatraemia. PR-interval prolongation

PDF page 351

Allergy And Cross Sensitivity

Antiepileptic hypersensitivity syndrome theoretically associated with eslicarbazepine. See under Epilepsy p. 321 for more information.

PDF page 351

Pre Treatment Screening

Test for HLA-B*1502 allele in individuals of Han Chinese or Thai origin (avoid unless no alternative— risk of Stevens-Johnson syndrome in presence of HLA-B*1502 allele).

PDF page 351

Prescribing And Dispensing Information

Switching between formulations Care should be taken when switching between oral formulations. The need for continued supply of a particular manufacturer’s product should be based on clinical judgement and consultation with the patient or their carer, taking into account factors such as seizure frequency and treatment history.

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National Funding Access Decisions

Scottish Medicines Consortium (SMC) decisions SMC No. 592/09 The Scottish Medicines Consortium has advised (November 2010) that eslicarbazepine (Zebinix ®) is accepted for restricted use within NHS Scotland as adjunctive therapy in adults with focal seizures with or without secondary generalisation. It is restricted for use in refractory epilepsy in patients who have been heavily pre-treated and remain uncontrolled with existing anti-epileptic drugs. This advice is contingent upon the continuing availability of the patient access scheme in Scotland. All Wales Medicines Strategy Group (AWMSG) decisions AWMSG No. 1214 The All Wales Medicines Strategy Group has advised (June 2019) that eslicarbazepine acetate (Zebinix ®) is recommended as an option for restricted use within NHS Wales for the treatment of highly refractory patients who remain uncontrolled with, or are intolerant to, other anti- epileptic medicine combinations, within its licensed indication as adjunctive therapy in adults, adolescents and children aged above six years, with partial onset seizures, with or without secondary generalisation. It is not recommended for use within NHS Wales outside of this subpopulation.

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Safety

Interactions

→Appendix 1: antiepileptics

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Side Effects

▶Common or very common Appetite decreased. asthenia. concentration impaired. diarrhoea. dizziness. drowsiness . electrolyte imbalance. gait abnormal. headaches. movement disorders. nausea. skin reactions. sleep disorders. vertigo. vision disorders. vomiting ▶Uncommon Alopecia. anaemia. anxiety. bradycardia. chest pain. chills. confusion. constipation. depression. dry mouth. eye disorders. ﬂushing. gastritis. gastrointestinal discomfort. haemorrhage. hearing impairment. hyperhidrosis. hypertension. hypotension. hypothyroidism. increased risk of infection. liver disorder . malaise. mood altered. muscle weakness. myalgia. pain in extremity. palpitations. peripheral coldness. peripheral neuropathy. peripheral oedema. psychomotor retardation . psychotic disorder. sensation abnormal. speech impairment. tinnitus. toothache. weight decreased ▶Frequency not known Angioedema. leucopenia. pancreatitis. severe cutaneous adverse reactions (SCARs). thrombocytopenia

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Pregnancy

Manufacturer advises minimum effective doses and monotherapy if possible—reproductive toxicity in animal studies. Monitoring The dose should be monitored carefully during pregnancy and after birth, and adjustments made on a clinical basis.

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Breast Feeding

Manufacturer advises avoid—present in Nervous system milk in animal studies.

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Hepatic Impairment

Manufacturer advises caution in mild to moderate impairment—limited information; avoid in severe impairment—no information available.

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Renal Impairment

Manufacturer advises avoid if creatinine creatinine clearance less than 30 mL/minute. Dose adjustments Manufacturer advises reduce initial dose to 200 mg once daily or 400 mg every other day for 2 weeks, then increase to 400 mg once daily if creatinine clearance 30–60 mL/minute. The dose may be further increased based on individual response.

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Monitoring Requirements

Monitor plasma-sodium concentration in patients at risk of hyponatraemia and discontinue treatment if hyponatraemia occurs.

PDF page 351

Dose and formulations

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Oral suspension CAUTIONARY AND ADVISORY LABELS 8 ▶Zebinix (Eisai Ltd) Eslicarbazepine acetate 50 mg per 1 ml Zebinix 50mg/1ml oral suspension sugar-free | 200 ml P £56.67 DT = £56.67 Tablet CAUTIONARY AND ADVISORY LABELS 8 ▶Zebinix (Eisai Ltd) Eslicarbazepine acetate 200 mg Zebinix 200mg tablets | 60 tablet P £68.00 DT = £68.00 Eslicarbazepine acetate 800 mg Zebinix 800mg tablets | 30 tablet P £136.00 DT = £136.00 Nervous system

PDF pages 351, 352

Clinical care

Patient And Carer Advice

Driving and skilled tasks Manufacturer advises patients and carers should be cautioned on the effects on driving and performance of skilled tasks—increased risk of dizziness, somnolence and visual disorders.

PDF page 351

Dose text by age group

Adult

Initially 400 mg once daily for 1–2 weeks, then

First-line fragment. Read the complete Indications and Dose section above.

PDF page 351

Elderly

Initially 400 mg once daily for 1–2 weeks, then

First-line fragment. Read the complete Indications and Dose section above.

PDF page 351

Adult

Initially 400 mg once daily for 1–2 weeks, then

First-line fragment. Read the complete Indications and Dose section above.

PDF page 351

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Eslicarbazepine acetate

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 351, 352

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

PDF page 351

Contra Indications

Second- or third-degree AV block

PDF page 351

Cautions

Elderly. hyponatraemia. PR-interval prolongation

PDF page 351

Allergy And Cross Sensitivity

Antiepileptic hypersensitivity syndrome theoretically associated with eslicarbazepine. See under Epilepsy p. 321 for more information.

PDF page 351

Pre Treatment Screening

Test for HLA-B*1502 allele in individuals of Han Chinese or Thai origin (avoid unless no alternative— risk of Stevens-Johnson syndrome in presence of HLA-B*1502 allele).

PDF page 351

Prescribing And Dispensing Information

PDF page 351

National Funding Access Decisions

PDF page 351

Safety

Interactions

→Appendix 1: antiepileptics

PDF page 351

Side Effects

PDF page 351

Pregnancy

PDF page 351

Breast Feeding

Manufacturer advises avoid—present in Nervous system milk in animal studies.

PDF page 351

Hepatic Impairment

Manufacturer advises caution in mild to moderate impairment—limited information; avoid in severe impairment—no information available.

PDF page 351

Renal Impairment

PDF page 351

Monitoring Requirements

Monitor plasma-sodium concentration in patients at risk of hyponatraemia and discontinue treatment if hyponatraemia occurs.

PDF page 351

Dose and formulations

Medicinal Forms

PDF pages 351, 352

Clinical care

Patient And Carer Advice

PDF page 351

Dose text by age group

Adult

Initially 400 mg once daily for 1–2 weeks, then

First-line fragment. Read the complete Indications and Dose section above.

PDF page 351

Elderly

Initially 400 mg once daily for 1–2 weeks, then

First-line fragment. Read the complete Indications and Dose section above.

PDF page 351

Adult

Initially 400 mg once daily for 1–2 weeks, then

First-line fragment. Read the complete Indications and Dose section above.

PDF page 351

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.