Schedule H

Oral

• Tablet (film-coated): 200 mg, 400 mg, 600 mg, 800 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

➤ Partial-onset seizures (focal seizures) — Adults ≥18 years

Parameter Monotherapy Adjunctive Therapy

Starting dose 400 mg once daily 400 mg once daily

Titration Increase to 800 mg once daily after 1 week Increase to 800 mg once daily after 1–2 weeks

Usual maintenance dose 800–1600 mg once daily 800–1200 mg once daily

Maximum dose 1600 mg once daily 1200 mg once daily

Clinical notes:

• Administer once daily, with or without food

• Higher doses improve seizure control but increase hyponatraemia and dizziness risk

• Slow titration reduces tolerability issues

Secondary Indications — Adults (Off-label, if any)

Indication Dose Duration Notes

Post-stroke epilepsy (OFF-LABEL) 400–800 mg once daily Long-term as per seizure control Specialist only; limited pilot trial data; not standard practice in India

Evidence basis: Small international pilot studies; no robust Indian data available

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

➤ Partial-onset seizures — Children ≥4 years (Adjunctive therapy only)

Body Weight Starting Dose Titration Maintenance Range Maximum Dose

11–20 kg 100–200 mg once daily Increase weekly by 100 mg 200–400 mg/day 600 mg/day

21–30 kg 200–300 mg once daily Increase weekly by 100–200 mg 400–600 mg/day 800 mg/day

31–40 kg 300–400 mg once daily Increase weekly by 200 mg 500–800 mg/day 1000 mg/day

40 kg 400 mg once daily Increase weekly by 200 mg 800–1200 mg/day 1200 mg/day

Weight-based calculation: 10 mg/kg/day initially; titrate to 20–30 mg/kg/day

Clinical notes:

• Minimum age: 4 years

• Must be supervised by paediatric neurologist

• Monitor serum sodium closely due to higher hyponatraemia risk

• Safety monitoring: Baseline and periodic sodium, renal function, CNS symptoms

Secondary Indications — Paediatrics (Off-label, if any)

Not applicable — no standard off-label paediatric indications documented in India.

Important: NOT RECOMMENDED for children <4 years except under specialist research protocol with ethics approval.

• Known hypersensitivity to eslicarbazepine, oxcarbazepine, or carbamazepine

• Second-degree or third-degree atrioventricular block

• Severe hepatic impairment (Child-Pugh C)

• Concurrent use with oxcarbazepine (structural similarity, cross-reactivity risk)

• Pre-existing hyponatraemia or conditions predisposing to low sodium (SIADH, elderly, diuretic use)

• History of cardiac arrhythmias or PR interval prolongation

• Renal impairment (dose adjustment required)

• Elderly patients (higher fall risk, sodium disturbances)

• Concurrent use with other sodium-channel blocking antiepileptics

• History of psychiatric illness — monitor for suicidal ideation (class warning for all antiepileptics)

• HLA-B*1502 positive patients of Asian ancestry — increased risk of serious skin reactions

Parameter Details

Risk category Not formally classified in India; considered potentially teratogenic based on class data

Known risks Neural tube defects, cleft lip/palate, cardiac malformations (class effect)

Preferred alternatives Levetiracetam, lamotrigine (Indian obstetric neurology preference)

When may be used Only if seizure control cannot be achieved with safer alternatives; specialist decision

Monitoring Folic acid supplementation (5 mg/day) mandatory; detailed fetal anomaly scan at 18–20 weeks; maternal serum drug level monitoring

Parameter Details

Compatibility Likely compatible; use with caution

Drug levels in milk Low to moderate excretion expected

Preferred alternatives Levetiracetam, lamotrigine (when initiating new AED in breastfeeding mothers)

Infant monitoring Observe for sedation, poor feeding, irritability, developmental milestones

Parameter Recommendation

Starting dose 200–400 mg once daily

Titration Slower than standard — increase at 2-week intervals

Extra risks Hyponatraemia (especially with concurrent diuretics/SSRIs), dizziness, falls, cognitive impairment, fractures

Monitoring Check renal function and serum sodium at baseline and every 3 months

Interacting Drug Effect Clinical Action

Phenytoin Eslicarbazepine inhibits CYP2C19 → ↑ phenytoin levels by 30–35% Reduce phenytoin dose by ~30%; monitor phenytoin levels

Combined oral contraceptives CYP3A4 induction → ↓ ethinylestradiol and levonorgestrel efficacy Use alternative or additional contraception (barrier method)

Carbamazepine Additive CNS depression + ↑ hyponatraemia risk; CYP3A4 induction reduces eslicarbazepine levels Avoid combination

Oxcarbazepine Structural similarity → cross-reactivity, additive toxicity Contraindicated together

MAO inhibitors Theoretical CNS excitation risk Avoid concurrent use

Strong CYP3A4 inducers (rifampicin, phenobarbital) ↓ Eslicarbazepine plasma levels → reduced seizure control Monitor seizure frequency; consider dose increase

Interacting Drug Effect Clinical Action

Warfarin May alter INR unpredictably Monitor INR closely when initiating or stopping eslicarbazepine

SSRIs/SNRIs Additive risk of hyponatraemia Monitor serum sodium

Thiazide/loop diuretics Additive hyponatraemia Monitor electrolytes closely

Lithium Risk of additive neurotoxicity Use with caution; monitor lithium levels and neurological status

Lamotrigine Minor reduction in lamotrigine levels Usually clinically insignificant; monitor seizure control

Valproate Additive CNS effects Monitor for sedation

Simvastatin/atorvastatin CYP3A4 induction may reduce statin efficacy Consider higher statin dose if needed; monitor lipid profile

• Dizziness (most common)

• Somnolence

• Headache

• Nausea and vomiting

• Diplopia and blurred vision

• Fatigue

• Ataxia and gait disturbance

• Hyponatraemia (dose-related; usually asymptomatic)

• Cognitive slowing

Adverse Effect Action Required

Stevens-Johnson syndrome / Toxic epidermal necrolysis Immediate discontinuation; dermatology referral; hospitalisation

DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms) Immediate discontinuation; systemic management

Severe hyponatraemia (<125 mmol/L) May require hospitalisation; fluid restriction; withhold drug

Suicidal ideation/behaviour Monitor closely; psychiatric referral if needed

Agranulocytosis (rare) Check CBC if unexplained fever/infection; discontinue if confirmed

Cardiac conduction abnormalities (PR prolongation) ECG monitoring in at-risk patients

Timepoint Parameters

Baseline Serum sodium, renal function (eGFR), LFTs; ECG if cardiac risk factors or elderly; HLA-B*1502 screening in appropriate ethnic groups

2–4 weeks after initiation/dose change Serum sodium; clinical assessment for CNS effects, rash, mood changes

Long-term (every 3–6 months) Serum sodium, renal function; seizure frequency diary; mood and suicidal ideation screening

Brand Name Manufacturer

Zebinix Sun Pharma

Explemed Lupin

Eslify Torrent

Exetira Intas

Strength Approximate Price per Tablet

400 mg ₹10–25

600 mg ₹15–30

800 mg ₹18–35

Notes:

• Not under NPPA price control

• Not listed in NLEM 2022

• Primarily available in private sector; limited government supply

1. Once-daily dosing is a major advantage over carbamazepine and oxcarbazepine for compliance

1. Slower titration in elderly and renally impaired patients significantly reduces dropout due to dizziness and hyponatraemia

1. Cross-reactivity with carbamazepine and oxcarbazepine exists — approximately 25–30% of patients allergic to carbamazepine may react to eslicarbazepine

1. Sodium monitoring is essential in the first month and after every dose escalation — most cases of hyponatraemia are asymptomatic but clinically significant

1. Not a first-line monotherapy in India; typically reserved when carbamazepine/oxcarbazepine cause intolerable side effects or drug interactions

1. Women of childbearing potential must be counselled about reduced contraceptive efficacy and teratogenic risks before starting therapy

eslicarbazepine; partial seizures; focal epilepsy; sodium channel blocker; carbamazepine alternative; oxcarbazepine alternative; hyponatremia risk; antiepileptic; Schedule H India; once-daily AED

RxIndia v1.0 — 12 Jan 2025

• CDSCO approved product insert (Zebinix)

• Indian Pharmacopoeia / National Formulary of India (NFI)

• API Textbook of Medicine, 11th Edition

• AIIMS Neurology Department Formulary

• ICMR Guidelines on Epilepsy (Draft 2021)

• NLEM 2022 (drug not listed)

• International RCTs on paediatric adjunctive therapy (supportive data only; off-label context)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (reference for pharmacokinetics)