Schedule H

Oral, Intravenous

• Tablets: 50 mg, 100 mg, 150 mg, 200 mg

• Oral Solution: 10 mg/mL

• Injection: 200 mg/20 mL (10 mg/mL)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Focal Onset Seizures (Partial-Onset Seizures) with or without Secondary Generalisation — Adults

As monotherapy or adjunctive therapy in adults with focal epilepsy.

Oral Administration:

Parameter Recommendation

Starting dose 50 mg orally twice daily (100 mg/day)

Titration Increase by 50 mg twice daily (100 mg/day) at weekly intervals based on response and tolerability

Usual maintenance dose 100–200 mg twice daily (200–400 mg/day)

Maximum dose 200 mg twice daily (400 mg/day)

Intravenous Administration:

Parameter Recommendation

Starting dose 50 mg IV twice daily (equivalent to oral dose)

Titration Same as oral regimen

Usual maintenance dose 100–200 mg IV twice daily

Maximum dose 200 mg twice daily (400 mg/day)

Clinical Notes:

• IV formulation intended for short-term use when oral administration is temporarily not feasible

• IV to oral conversion: 1:1 dose ratio; no adjustment required

• Infuse IV dose over 15–60 minutes

• Loading dose option (urgent initiation): 200 mg IV single dose followed by 100 mg twice daily after 12 hours — specialist supervision required

• Monitor ECG in patients with known cardiac conduction abnormalities or on concomitant PR-prolonging drugs

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

Indication Dose Duration Notes

Diabetic Neuropathic Pain Starting: 50–100 mg twice daily; Maximum: 200 mg twice daily Limited to 12 weeks; not validated for chronic use OFF-LABEL; Specialist only (Neurology/Pain Medicine); Evidence: Small RCTs and international case series; Not in Indian guidelines

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Focal Onset Seizures — Children ≥4 Years

Approved from 4 years of age in India as monotherapy or adjunctive therapy.

Weight-Based Dosing (11–30 kg):

Parameter Recommendation

Starting dose 1 mg/kg orally twice daily

Titration Increase by 1 mg/kg twice daily at weekly intervals

Usual maintenance dose 2–4 mg/kg twice daily

Maximum dose 6 mg/kg twice daily (or 400 mg/day, whichever is lower)

Fixed Dosing (Body Weight >30 kg or Adolescents approaching adult weight):

Parameter Recommendation

Starting dose 50 mg orally twice daily

Titration Increase by 50 mg twice daily at weekly intervals

Usual maintenance dose 100–200 mg twice daily

Maximum dose 200 mg twice daily (400 mg/day)

Clinical Notes:

• Minimum age: 4 years

• Oral solution (10 mg/mL) preferred for accurate weight-based dosing in younger children

• ECG recommended if personal or family history of cardiac arrhythmia

• Monitor for neuropsychiatric symptoms (behavioural changes, mood disturbances)

• IV formulation may be used in children when oral route not feasible (same dose as oral)

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

Not applicable.

• No established off-label paediatric indications in Indian practice

Not recommended below 4 years of age except under specialist supervision in tertiary centres.

• Known hypersensitivity to lacosamide or any excipient

• Second-degree or third-degree atrioventricular (AV) block (unless patient has functioning pacemaker)

• Severe cardiac disease with significant conduction abnormalities (without pacemaker)

• First-degree AV block or PR interval prolongation — monitor ECG; may worsen conduction

• Concurrent use with other PR-prolonging drugs (beta-blockers, calcium channel blockers, digoxin)

• Concurrent use with other sodium channel blocking antiepileptics (carbamazepine, phenytoin, oxcarbazepine) — additive cardiac and CNS effects

• Sick sinus syndrome without pacemaker

• History of myocardial infarction or heart failure

• Neuropsychiatric symptoms — increased risk of suicidal ideation and behaviour (FDA/EMA class warning for all AEDs)

• History of depression or psychiatric illness

• Renal or hepatic impairment — dose adjustment required

• Elderly patients — increased sensitivity to adverse effects

• Avoid abrupt discontinuation — risk of seizure exacerbation; taper over at least 1 week

Parameter Details

Risk Category Limited human data; animal studies show developmental toxicity at high doses

Recommendation Use only if potential benefit clearly outweighs risk; avoid if possible in first trimester

Preferred Alternatives Levetiracetam, lamotrigine (better safety data in pregnancy; preferred in Indian obstetric practice)

When May Be Used If seizure control inadequate with safer alternatives; monotherapy at lowest effective dose preferred

Monitoring Fetal anomaly scan (detailed at 18–20 weeks); maternal ECG if cardiac risk factors; therapeutic drug monitoring not routinely required

Note: Encourage enrolment in pregnancy registries for antiepileptic drugs.

Parameter Details

Compatibility Likely compatible with breastfeeding; limited human data

Drug Levels in Milk Low to moderate; relative infant dose estimated <10%

Preferred Alternatives Levetiracetam, lamotrigine (more established safety profile during lactation)

Infant Monitoring Monitor for sedation, poor feeding, irritability, and adequate weight gain

Parameter Recommendation

Starting dose 50 mg once daily or 25 mg twice daily

Titration Slower titration — every 2 weeks rather than weekly

Special Risks Increased risk of PR interval prolongation, AV block, dizziness, falls, cognitive impairment, hyponatraemia

Monitoring ECG at baseline and after dose escalation; renal function; electrolytes

Maximum dose Titrate cautiously; many elderly patients controlled at 200–300 mg/day

Interacting Drug Mechanism / Effect Recommendation

PR-prolonging drugs (beta-blockers, verapamil, diltiazem, digoxin, ivabradine) Additive PR prolongation; increased risk of AV block and bradycardia ECG monitoring before and after initiation; avoid combination if baseline PR >200 ms; cardiologist input if high risk

Other sodium channel blocking AEDs (carbamazepine, phenytoin, oxcarbazepine, eslicarbazepine) Additive cardiac and CNS effects; possible reduced efficacy of lacosamide Use with caution; ECG monitoring; consider alternative AED combinations

Strong CYP3A4/CYP2C9 inducers (rifampicin, phenytoin, carbamazepine, phenobarbital) May reduce lacosamide plasma levels by up to 25% Monitor seizure control; may need lacosamide dose increase

Interacting Drug Mechanism / Effect Recommendation

Alcohol Additive CNS depression; increased sedation and dizziness Advise avoidance or minimal alcohol consumption

Other CNS depressants (benzodiazepines, opioids, sedating antihistamines) Additive sedation Monitor for excessive drowsiness; advise caution with driving

QT-prolonging drugs (macrolides, fluoroquinolones, antipsychotics, ondansetron) Although lacosamide primarily affects PR interval, combined cardiac monitoring advisable in high-risk patients ECG if multiple cardiac-active drugs

Metformin Lacosamide may slightly reduce metformin clearance Usually not clinically significant; monitor if concerns

• Dizziness (most common; dose-related)

• Headache

• Nausea and vomiting

• Diplopia (double vision)

• Blurred vision

• Tremor

• Fatigue and somnolence

• Ataxia / gait disturbance

• Nystagmus

• Memory impairment

Note: Most CNS adverse effects are dose-related and improve with slower titration.

Adverse Effect Clinical Action

Cardiac arrhythmias (AV block, bradycardia, syncope) Discontinue immediately; ECG; cardiology referral; hospitalisation if symptomatic

Suicidal ideation / behaviour Monitor closely; psychiatric evaluation; consider discontinuation if severe

Multiorgan hypersensitivity reaction (DRESS syndrome) Discontinue immediately; supportive care; specialist referral

Severe skin reactions (SJS/TEN — rare) Discontinue immediately; hospitalisation; dermatology input

Hepatotoxicity (rare) Monitor LFTs if symptoms; discontinue if significant elevation

Severe hyponatraemia Particularly in elderly or those on diuretics; check electrolytes

Status epilepticus on abrupt withdrawal Never stop abruptly; taper over at least 1 week

2–4 weeks after initiation/dose change ECG (especially if cardiac risk factors or on PR-prolonging drugs); assess tolerability (dizziness, vision); mood and behaviour assessment

Every 3–6 months Seizure frequency; adverse effects review; mood/behaviour; adherence assessment

Annually or as indicated LFTs; renal function (especially in elderly); ECG if new cardiac symptoms or medication changes

• Vimpat (UCB)

• Lacoset (Torrent)

• Lacosam (Sun Pharma)

• Lacoxa (Cipla)

• Lacepsy (Intas)

• Seizgard-L (Mankind)

• Laconext (Alkem)

• Generic versions from multiple manufacturers

Note: FDCs not applicable for lacosamide.

• Not included in NLEM 2022; pricing not NPPA-controlled

• Available in some tertiary government hospitals

• Costs vary significantly across brands

• Lacosamide has minimal hepatic enzyme induction/inhibition — advantageous for patients on multiple medications or with comorbidities requiring polypharmacy

• Unique mechanism (enhances slow inactivation of sodium channels) — useful when other sodium channel blockers have failed or are poorly tolerated

• 1:1 IV to oral bioequivalence allows seamless perioperative or ICU transitions without dose adjustment

• Slower titration (every 2 weeks instead of weekly) significantly reduces dizziness and improves tolerability, especially in elderly

• PR interval prolongation is dose-dependent — obtain baseline ECG in all patients and repeat during titration if cardiac risk factors present

• Not first-line for generalised epilepsies (absence, myoclonic, generalised tonic-clonic) — efficacy not established; may worsen some seizure types

• Suicidal ideation risk applies to all AEDs — brief mood screening at each visit is good practice

Lacosamide; antiepileptic; focal seizures; partial epilepsy; sodium channel modulator; PR prolongation; cardiac monitoring; IV-oral switch; paediatric-approved; renal-adjustment; Schedule H

RxIndia v1.0 — 05 May 2025

• CDSCO approved product information

• Indian Pharmacopoeia (IP)

• National Formulary of India (NFI) 2021

• API Textbook of Medicine — Epilepsy chapter

• ICMR Guidelines on Epilepsy Management

• AIIMS Neurology Department Treatment Protocols

• Indian Epilepsy Society recommendations

• Goodman & Gilman's: The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• UCB Vimpat Product Insert (India)

• WHO Model Formulary (supportive reference)