Formulary
Eslicarbazepine acetate: Indications, Dosing, Side Effects and Interactions
Eslicarbazepine acetate clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 4 min read
Eslicarbazepine acetate: Indications, Dosing, Side Effects and Interactions
Eslicarbazepine acetate clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Monotherapy of focal seizures with or without secondary generalisation**
- **Adult** (By Mouth): 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** (By Mouth): 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**
- **Adult** (By Mouth): 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 for eslicarbazepine acetate**
- **Child 6-17 years (body-weight up to 60 kg)** (By mouth): Initially 10 mg/kg once daily, then increased in steps of 10 mg/kg daily, every 1-2 weeks, increased if necessary up to 30 mg/kg daily (max. per dose 1.2 g).
- **Child 6-17 years (body-weight 60 kg and above)** (By mouth): Initially 400 mg once daily for 1-2 weeks, then increased to 800 mg once daily (max. per dose 1.2 g).
Cautions
Hyponatraemia; PR-interval prolongation; presence of HLA-B*1502 or HLA-A*3101 allele Cautions, further information HLA allele The presence of HLA-B*1502 allele, particularly in individuals of Han Chinese or Thai origin, is strongly associated with an increased risk of carbamazepine-induced Stevens-Johnson syndrome; this may also occur with eslicarbazepine acetate, a structurally-related antiepileptic-see also Pre-treatment screening . M The presence of HLA-A*3101 allele, particularly in individuals of European or Japanese origin, is associated with an increased risk of carbamazepine-induced cutaneous adverse reactions. This may also occur with eslicarbazepine acetate, a structurally-related antiepileptic, but there are insufficient data to support pre-treatment screening. Consider use if potential benefit outweighs risk. M
Contraindications
Second- or third-degree AV block
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; tremor; vertigo; vision disorders; vomiting; weight changes Uncommon Alopecia; altered smell sensation; anaemia; anxiety; bone metabolism disorder; bradycardia; cerebellar syndrome; chest pain; chills; confusion; constipation; crying; dehydration; depression; dry mouth; eye disorders; flushing; gastritis; gastrointestinal discomfort; haemorrhage; hearing impairment; hyperhidrosis; hypertension; hypotension; hypothyroidism; increased risk of infection; liver disorder; malaise; memory impairment; 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 Frequency not known Angioedema; inappropriate antidiuretic hormone secretion like-syndrome; leucopenia; pancreatitis; severe cutaneous adverse reactions (SCARs); suicidal behaviours; thrombocytopenia
Interactions
**Severe interactions:**
- Topiramate In a study in healthy subjects, concomitant administration of Eslicarbazepine acetate 1,200 mg once daily and topiramate showed no significant change in exposure to eslicarbazepine but an...
- Warfarin Co-administration of Eslicarbazepine acetate 1,200 mg once daily with warfarin showed a small (23%), but statistically significant decrease in exposure to S-warfarin.
**Other interactions (25):**
- Eslicarbazepine acetate is extensively converted to eslicarbazepine, which is mainly eliminated by glucuronidation.
- Thus, an increase in the dose of the medicinal products that are mainly metabolised through CYP3A4 may be required, when used concomitantly with Eslicarbazepine acetate.
- Eslicarbazepine in vivo may have an inducing effect on the metabolism of medicinal products that are mainly eliminated by conjugation through the UDP-glucuronyl transferases.
- Eslicarbazepine has inhibiting properties with respect to CYP2C19.
- Thus, interactions can arise when co-administering high doses of Eslicarbazepine acetate with medicinal products that are mainly metabolised by CYP2C19 (e.g.
- Interactions with other antiepileptic medicinal products Carbamazepine In a study in healthy subjects, concomitant administration of Eslicarbazepine acetate 800 mg once daily and carbamazepine 400...
Pregnancy
Important safety information For eslicarbazepine acetate MHRA/CHM advice: Antiepileptics: risk of suicidal thoughts and behaviour (August 2008) See Epilepsy . MHRA/CHM advice: Antiepileptic drugs: updated advice on switching between different manufacturers' products (November 2017) See Epilepsy and see also Prescribing and dispensing information . MHRA/CHM advice: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review (January 2021) See Epilepsy .
Breast feeding
Manufacturer advises avoid-present in milk in animal studies.
Hepatic impairment
Manufacturer advises caution in mild to moderate impairment-limited information; avoid in severe impairment-no information available.
Renal impairment
Manufacturer advises avoid if creatinine clearance less than 30 mL/minute. Dose adjustments See Prescribing in renal impairment . 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.
Medicinal forms
Tablet,Suspension
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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