LAZURE 50/MG FC TAB 60/FC TAB

Indications

Approved Uses

Treatment of focal (partial-onset) seizures; adjunctive therapy for primary generalized tonic-clonic seizures (PGTCS).

Dosage & Administration

Dosing by Condition

Focal seizures (adjunctive or monotherapy, adults): start 50 mg twice daily (100 mg/day), increase by 50 mg twice daily (100 mg/day) at weekly intervals as needed; maintenance typically 100-200 mg twice daily (200-400 mg/day), with some monotherapy regimens using a lower maximum (e.g., 300 mg/day) per local labeling. PGTCS (adjunctive, adults): start 50 mg twice daily, titrate weekly by 100 mg/day; maintenance 100-200 mg twice daily (200-400 mg/day).

Initial Dose

Adjunctive therapy: 50 mg twice daily. Monotherapy: 100 mg twice daily.

Maintenance Dose

150-400mg/day in two divided doses depending on indication and tolerability

Maximum Dose

400mg/day (monotherapy and adjunctive therapy)

Children's Dosage

Pediatric Patients 1 month to less than 17 years: The recommended dosage is based on body weight and is administered orally twice daily.

Dose Adjustment Notes

Renal: in severe impairment (CrCl ≤30 mL/min) and ESRD, reduce maximum dose by 25%; Hepatic: in mild-moderate impairment, max 300 mg/day; severe hepatic impairment not recommended; titrate based on tolerability.

How to Take

Swallow tablet whole with water; may be taken with or without food; administer twice daily (approximately 12 hours apart) as prescribed.

Side Effects

Common Side Effects

Dizziness, Headache, Nausea, Diplopia (double vision), Somnolence (sleepiness), Fatigue, Blurred vision, Ataxia (impaired coordination).

Side Effect Frequency

Very common (≥10%): dizziness, headache, diplopia, nausea. Common (1-10%): somnolence, fatigue/asthenia, ataxia, balance disorder/gait disturbance, tremor, blurred vision/vertigo, vomiting, memory impairment, confusional state, depression/irritability, nystagmus; rash/pruritus can occur. Uncommon/rare: PR-interval prolongation, AV block, atrial fibrillation/flutter, syncope; serious hypersensitivity (e.g., DRESS) and suicidal ideation are rare but clinically important.

Safety & Warnings

Contraindications

Known hypersensitivity to lacosamide or any excipients

Warnings & Precautions

Precautions: assess/monitor for cardiac conduction abnormalities (consider baseline and follow-up ECG in patients with conduction disease, significant cardiac disease, or on PR-prolonging drugs); monitor for suicidal thoughts/behavior; caution for dizziness/ataxia and fall risk; discontinue gradually; stop and evaluate if hypersensitivity/DRESS suspected.

Age Restriction

Approved for partial-onset seizures in patients 1 month of age and older; primary generalized tonic-clonic seizures in patients 4 years of age and older.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Key interactions: (1) Additive PR-interval prolongation/AV block risk with other PR-prolonging drugs (e.g., beta-blockers, non‑DHP calcium channel blockers, digoxin, other sodium-channel blockers); (2) Enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampicin) can decrease lacosamide exposure; (3) Strong CYP2C19 inhibitors (e.g., omeprazole, fluconazole) may increase lacosamide exposure; (4) Additive CNS effects with other CNS depressants/ASMs.

Interaction Severity

MAJOR: Additive PR-interval prolongation/AV block risk with other PR-prolonging or AV-nodal-slowing drugs (e.g., beta-blockers, verapamil/diltiazem, digoxin, amiodarone). MODERATE: Strong enzyme inducers (e.g., carbamazepine, phenytoin, rifampin) may lower lacosamide concentrations; CNS depressants/alcohol may increase dizziness/somnolence. MINOR: CYP2C19 inhibitors may modestly increase levels but are usually not clinically significant.

Food Interaction

No clinically meaningful food restriction; may be taken with or without food.

Special Populations

Children

Pediatric Patients 1 month to less than 17 years: The recommended dosage is based on body weight and is administered orally twice daily.

Kidney Impairment

CrCl >30 mL/min: no adjustment. Severe renal impairment (CrCl ≤30 mL/min) or end-stage renal disease: reduction of 25% of the maximum dosage; consider a supplemental dose following hemodialysis.

Liver Impairment

Mild to moderate hepatic impairment (Child-Pugh A/B): reduction of 25% of the maximum dosage; titrate based on clinical response and tolerability. Severe hepatic impairment (Child-Pugh C): not recommended.

Storage & Patient Advice

Patient Counseling

Take lacosamide exactly as prescribed (usually twice daily) at the same times each day; swallow the film‑coated tablet with or without food. Do not stop suddenly-taper only under prescriber direction to avoid seizure worsening. If you miss a dose, take it when remembered unless it is close to the next dose; do not double. May cause dizziness, drowsiness, blurred/double vision and unsteadiness-avoid driving/operating machinery until you know your response; avoid alcohol/CNS depressants. Seek medical advice urgently for new/worsening depression, mood/behavior changes, or suicidal thoughts. Tell your doctor if you have heart disease or conduction problems and seek care for palpitations, slow/irregular heartbeat, fainting, or marked lightheadedness (PR‑interval prolongation/AV block risk); ECG monitoring may be needed in at‑risk patients.

Monitoring Requirements

Monitor for suicidal ideation/behavior and CNS adverse effects (dizziness, ataxia); consider baseline and follow-up ECG in patients with known conduction disease, on PR-prolonging/AV-nodal-slowing drugs, or with significant cardiac disease; monitor renal/hepatic function when impairment is present.

Pharmacology

Mechanism of Action

Enhances slow inactivation of voltage-gated sodium channels, stabilizing hyperexcitable neuronal membranes and reducing repetitive firing; CRMP-2 binding has been described but its clinical relevance is uncertain.

Onset of Action

Oral Tmax ~1-4 hours; clinical seizure control may improve after initiation and titration to an effective dose (often within days to weeks depending on titration).

Duration of Effect

Supports twice-daily dosing; elimination half-life ~13 hours (clinical effect maintained across ~12-hour dosing interval).

Half-Life

Approximately 13 hours.

Bioavailability

Approximately 100% (near-complete) oral bioavailability.

Metabolism

Limited metabolism; mainly O-demethylation to O-desmethyl-lacosamide (primarily via CYP2C19, with minor contributions from CYP3A4/CYP2C9), and lacosamide does not meaningfully induce or inhibit major CYP enzymes.

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: 50mg lacosamide

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Also Used For

Neuropathic Pain, Trigeminal Neuralgia

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 13-05-2026