Schedule H

Oral

Formulation Strength

Tablets 150 mg, 300 mg, 600 mg

Oral Suspension 60 mg/mL (select brands)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Focal (Partial) Seizures — Monotherapy or Adjunctive Therapy

(Adults and adolescents ≥16 years)

Parameter Recommendation

Starting dose 300 mg orally twice daily (600 mg/day)

Titration Increase by 300–600 mg/day at weekly intervals based on clinical response

Usual maintenance dose 600–1200 mg twice daily (total: 1200–2400 mg/day)

Maximum dose 2400 mg/day

Clinical Notes:

• Onset of therapeutic efficacy typically within 1–2 weeks

• When converting from carbamazepine, use approximately 1.5× equivalent dose

• Splitting dose into twice daily administration improves tolerability

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

Indication Dose Duration Notes Evidence

Bipolar disorder (mood stabilisation) 600–1200 mg/day in 2 divided doses Variable; based on clinical response OFF-LABEL; Specialist only; Not first-line — use only when lithium/valproate contraindicated or not tolerated Limited RCT support; used in Indian psychiatric practice for acute mania

Trigeminal neuralgia 300–1800 mg/day in divided doses Long-term; titrate to pain control OFF-LABEL; Specialist only Indian neurological practice; alternative to carbamazepine

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Focal (Partial) Seizures — Children ≥6 years

Weight/Age Starting Dose Titration Maintenance Dose Maximum Dose

20–29 kg 300 mg/day in 2 divided doses Increase by 300 mg/day every 3–7 days 900 mg/day 1800 mg/day

30–39 kg 300 mg/day in 2 divided doses Increase by 300 mg/day every 3–7 days 1200 mg/day 1800 mg/day

≥40 kg 300–600 mg/day in 2 divided doses Increase by 300–600 mg/day weekly 1200–2400 mg/day 2400 mg/day

OR Weight-based Dosing:

Parameter Recommendation

Starting dose 8–10 mg/kg/day in 2 divided doses

Titration Increase by 5 mg/kg/day every 3–7 days

Usual maintenance dose 20–30 mg/kg/day in divided doses

Maximum dose 46 mg/kg/day OR 2400 mg/day (whichever is lower)

Secondary Indications — Paediatric Doses (Off-label, if any)

Not applicable.

No established off-label paediatric indications documented in Indian sources.

Safety Statement:

• Not recommended below 6 years except under paediatric neurologist supervision

• Monitor serum sodium during dose escalation — hyponatraemia risk significant in children

• Oral suspension (60 mg/mL) preferred for accurate dosing in younger/lighter children

Normal to mild impairment ≥30 No dose adjustment required

Moderate to severe impairment <30 Start at 50% of usual dose (e.g., 150–300 mg/day); titrate slowly with clinical monitoring

Haemodialysis — Not significantly dialyzed; no supplemental dose required; monitor sodium and clinical response

• Known hypersensitivity to oxcarbazepine, eslicarbazepine, or any excipient

• History of serious dermatologic reaction (SJS/TEN) to oxcarbazepine, carbamazepine, or related compounds

• Concurrent use with MAO inhibitors

• Risk of hyponatraemia — particularly in elderly, patients on diuretics, or those with renal impairment

• Cross-sensitivity with carbamazepine (~25–30%): exercise caution in patients with prior carbamazepine hypersensitivity

• Stevens-Johnson Syndrome/TEN risk — higher in patients of Asian ancestry with HLA-B*1502 allele

• May reduce efficacy of hormonal contraceptives (CYP3A4 induction)

• CNS depression (ataxia, sedation) — risk increases with rapid titration or polytherapy

• Suicidal ideation — monitor for behavioural changes, particularly during initiation

• Cardiac conduction abnormalities — use with caution in patients with pre-existing AV block

Parameter Recommendation

Risk category Moderate risk; potential teratogenicity (lower than valproate)

Preferred alternatives Lamotrigine or levetiracetam preferred for focal seizures in pregnancy

When to use Only if benefit outweighs risk; specialist neurology/obstetric input required

Monitoring Serum drug levels (MHD — active metabolite); fetal anomaly scan at 18–20 weeks; folate supplementation (5 mg/day) recommended

Parameter Recommendation

Compatibility Generally compatible with breastfeeding

Preferred alternatives Lamotrigine, levetiracetam if switching preferred

Drug levels in milk Low to moderate (active metabolite MHD detected)

Infant monitoring Sedation, feeding difficulties, poor weight gain; hyponatraemia if prolonged exposure

Parameter Recommendation

Starting dose 150–300 mg/day (lower than adults)

Titration Slow titration; increase by 150–300 mg/day at 1–2 week intervals

Special risks Increased susceptibility to hyponatraemia; sedation; dizziness; falls; reduced renal reserve

Monitoring Serum sodium at baseline and within 2 weeks; renal function; gait and balance assessment

Interacting Drug/Class Effect Mechanism Management

Hormonal contraceptives (OCPs, patches) Reduced contraceptive efficacy; risk of unintended pregnancy CYP3A4 induction by oxcarbazepine metabolite (MHD) Use alternative/additional contraception (barrier methods or IUD)

Phenytoin Increased phenytoin levels (up to 40%); risk of phenytoin toxicity Inhibition of CYP2C19 Monitor phenytoin levels; reduce phenytoin dose if needed

Carbamazepine, phenobarbital, phenytoin Reduced oxcarbazepine (MHD) levels Induction of glucuronidation May require higher oxcarbazepine doses; monitor seizure control

Sodium-depleting diuretics (thiazides, furosemide) Additive hyponatraemia Pharmacodynamic interaction Monitor sodium closely; avoid combination if possible

Interacting Drug/Class Effect Management

Valproate Generally safe; minor increase in MHD levels Monitor for CNS adverse effects

Lamotrigine Generally safe; no significant interaction Standard monitoring

Lithium Potential additive CNS effects Monitor for neurotoxicity

SSRIs/SNRIs Increased risk of hyponatraemia; rare serotonin syndrome-like reactions Monitor sodium; watch for CNS symptoms

Rifampicin Reduced oxcarbazepine efficacy Enzyme induction — may need dose increase

Warfarin Mild reduction in INR reported Monitor INR during initiation and dose changes

Alcohol Additive CNS depression Advise avoidance or caution

• Dizziness (20–30%)

• Somnolence/fatigue

• Headache

• Nausea, vomiting

• Diplopia/visual disturbances

• Ataxia

• Hyponatraemia (dose-dependent; up to 3%)

• Tremor

• Cognitive slowing

Most adverse effects are dose-related and improve with slower titration

Adverse Effect Action Required

Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis Discontinue immediately; hospitalisation; do not rechallenge

Severe hyponatraemia (<125 mmol/L) Discontinue or reduce dose; may present with seizures, confusion, coma

Anaphylaxis / angioedema Discontinue permanently; emergency management

DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms) Discontinue; specialist dermatology input

Hepatotoxicity (elevated transaminases, jaundice) Monitor LFTs; discontinue if significant elevation

Suicidal ideation / behaviour Close psychiatric monitoring; consider alternative if persistent

Multi-organ hypersensitivity Discontinue immediately; supportive care

Phase Parameters

Baseline Serum sodium; renal function (creatinine, eGFR); LFTs; seizure frequency documentation; consider HLA-B*1502 testing in high-risk populations

After initiation / dose change Serum sodium at 2 weeks and 1 month; clinical assessment for rash, CNS adverse effects; seizure diary

Long-term Serum sodium every 3–6 months (more frequently in elderly or those on diuretics); annual LFTs and renal function; bone health assessment with prolonged use

Brand Name Manufacturer Formulations

Oxetol Torrent Tablets 150, 300, 600 mg; Oral suspension 60 mg/mL

Zenoxa Intas Tablets 150, 300, 600 mg

Oxcarb Micro Labs Tablets 150, 300, 600 mg

Trioptal Sun Pharma Tablets 150, 300, 600 mg

Oxeptal Cipla Tablets 150, 300, 600 mg

Note: Trileptal (Novartis) — imported; limited availability in India

Notes:

• Not included in NLEM 2022

• Not under NPPA price control

• Available in government supply in select states

1. Cross-reactivity warning: ~25–30% cross-sensitivity with carbamazepine — avoid in patients with previous serious rash to carbamazepine

1. Hyponatraemia vigilance: Check sodium proactively, especially in elderly or those presenting with fatigue, confusion, or worsening seizures

1. Enzyme induction advantage: Less hepatic enzyme induction than carbamazepine — better choice in patients on multiple medications or hormonal therapy (though still affects OCPs)

1. Contraceptive counselling essential: Inform women of childbearing age about reduced OCP efficacy; recommend barrier methods or IUD

1. Slow titration reduces dropout: Rapid dose escalation increases dizziness and ataxia — titrate gradually, especially in elderly

1. Conversion from carbamazepine: When switching, start oxcarbazepine at ~1.5× the carbamazepine dose; can often cross-titrate over 1–2 weeks

oxcarbazepine; antiepileptic; focal seizures; partial seizures; hyponatraemia risk; SJS caution; carbamazepine alternative; paediatric epilepsy; elderly caution; Schedule H; neurology

RxIndia v1.0 — 10 Jun 2025

• CDSCO (Central Drugs Standard Control Organisation)

• Indian Pharmacopoeia / National Formulary of India (IP/NFI)

• NLEM 2022 (for exclusion note)

• API Textbook of Medicine

• AIIMS Neurology Treatment Protocols

• IAP Paediatric Epilepsy Guidelines

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• Indian Psychiatric Society Consensus Guidelines (for off-label bipolar use)

• Product Inserts: Oxetol (Torrent), Zenoxa (Intas)