LAZURE 200/MG FC TAB 60/FC TAB

Indications

Approved Uses

Treatment of focal (partial‑onset) seizures (as monotherapy or adjunctive therapy) and adjunctive therapy for primary generalized tonic‑clonic seizures (PGTCS).

Dosage & Administration

Dosing by Condition

Focal seizures (monotherapy or adjunct) and PGTCS (adjunct): start 50 mg twice daily; increase by 50 mg twice daily (100 mg/day) at weekly intervals to maintenance 100-200 mg twice daily (200-400 mg/day); maximum 200 mg twice daily (400 mg/day).

Initial Dose

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

Maintenance Dose

100-200mg twice daily (200-400mg/day)

Maximum Dose

400mg per day.

Children's Dosage

Children 4-17 years (≥50kg): same as adult dosing. Children 4-17 years (30-<50kg): 1-2mg/kg/day initial, titrate to 2-4 mg/kg twice daily (4-8mg/kg/day). Children 4-17 years (11-<30kg): 1-2mg/kg/day initial, titrate to 3-6 mg/kg twice daily (6-12mg/kg/day). Younger children (1 month-4 years): weight-based dosing as per table.

Dose Adjustment Notes

Titrate no more frequently than weekly (commonly by 100 mg/day increments). Renal: no adjustment for mild-moderate impairment; for severe renal impairment (CrCl ≤30 mL/min) or ESRD, reduce maximum daily dose to 300 mg/day and consider supplemental dosing after hemodialysis. Hepatic: for mild-moderate impairment, maximum 300 mg/day and titrate cautiously; severe hepatic impairment not recommended. Elderly: titrate cautiously due to higher likelihood of renal impairment/cardiac conduction disease.

How to Take

Swallow the film‑coated tablet whole with water; may be taken with or without food; administer twice daily (about every 12 hours) at the same times each day.

Side Effects

Common Side Effects

Dizziness, headache, nausea, diplopia (double vision), blurred vision, vomiting, fatigue, ataxia, tremor, somnolence

Side Effect Frequency

Very common (≥10%): dizziness, headache, diplopia, nausea. Common (1-10%): blurred vision, vomiting, constipation, fatigue/asthenia, somnolence, ataxia, tremor, balance/gait disturbance, vertigo, memory impairment, confusion, depression/irritability, pruritus/rash; PR-interval prolongation. Uncommon/rare: atrioventricular block, atrial fibrillation/flutter, syncope; serious hypersensitivity (e.g., DRESS) and severe cutaneous reactions (e.g., SJS/TEN); suicidal ideation/behavior.

Safety & Warnings

Warnings & Precautions

Precautions: risk of dizziness/ataxia and CNS depression (falls/driving impairment); monitor for suicidal ideation/behavior; obtain ECG/monitor in patients with known conduction abnormalities, significant cardiac disease, or on PR‑prolonging drugs; risk of atrial fibrillation/flutter (higher in cardiac/diabetic patients); discontinue if hypersensitivity/DRESS or severe rash suspected; withdraw gradually (do not stop abruptly).

Age Restriction

Approved in patients 1 month of age and older.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Key interactions: additive PR-interval prolongation/AV block with other PR-prolonging drugs (e.g., beta-blockers, non‑DHP calcium channel blockers, digoxin) and with other sodium-channel-acting antiseizure drugs; CNS depression may be additive with alcohol/sedatives; strong enzyme inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital, St John’s wort) can decrease lacosamide exposure; clinically meaningful increases from CYP inhibitors are generally limited (lacosamide has low interaction potential).

Interaction Severity

MAJOR/clinically significant: concomitant drugs that slow cardiac conduction or prolong PR interval (e.g., beta‑blockers, non‑DHP calcium channel blockers such as verapamil/diltiazem, digoxin, amiodarone) due to additive risk of AV block/arrhythmia. MODERATE: other CNS depressants including alcohol (additive dizziness/somnolence); other sodium‑channel ASMs (e.g., carbamazepine, phenytoin) may increase neuro/cardiac conduction adverse effects. MINOR: CYP2C19 inhibitors may modestly increase lacosamide exposure (usually not clinically significant but consider in high doses/at‑risk patients).

Food Interaction

No clinically significant food interaction; may be taken with or without food.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Children 4-17 years (≥50kg): same as adult dosing. Children 4-17 years (30-<50kg): 1-2mg/kg/day initial, titrate to 2-4 mg/kg twice daily (4-8mg/kg/day). Children 4-17 years (11-<30kg): 1-2mg/kg/day initial, titrate to 3-6 mg/kg twice daily (6-12mg/kg/day). Younger children (1 month-4 years): weight-based dosing as per table.

Elderly

No specific dose adjustment required based on age alone; however, titrate cautiously due to increased risk of cardiac conduction abnormalities and renal impairment in elderly patients. Monitor renal function.

Kidney Impairment

CrCl >30 mL/min: no adjustment. Severe renal impairment (CrCl ≤30 mL/min) and end‑stage renal disease: maximum 300 mg/day; after hemodialysis, a supplemental dose of up to 50% of the divided daily dose may be considered.

Liver Impairment

Mild to moderate hepatic impairment (Child‑Pugh A or B): titrate cautiously; maximum recommended dose 300 mg/day. Severe hepatic impairment (Child‑Pugh C): not recommended.

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually (typically over at least 1 week) to reduce the risk of increased seizure frequency/status epilepticus.

Overdose

Overdose may cause CNS effects (dizziness, somnolence, nausea/vomiting, seizures, coma) and cardiac conduction disturbances (PR prolongation, bradycardia, AV block, arrhythmias, hypotension); management is supportive with airway/ventilation as needed and continuous ECG monitoring; no specific antidote; consider activated charcoal if appropriate; lacosamide is dialyzable and hemodialysis can enhance removal.

Patient Counseling

Take lacosamide exactly as prescribed (usually twice daily) at the same times each day, with or without food. Do not stop suddenly-taper only under prescriber direction to reduce risk of increased seizures. May cause dizziness, drowsiness, blurred/double vision and coordination problems-avoid driving/operating machinery until you know your response. Avoid or limit alcohol and other CNS depressants. Report new/worsening depression, mood/behavior changes, or suicidal thoughts immediately. Tell your prescriber if you have heart disease, conduction problems, history of syncope, or are taking other PR‑prolonging/antiarrhythmic drugs; ECG monitoring may be needed. Seek urgent care for rash, fever, facial swelling, or other hypersensitivity symptoms. Store below 30°C and keep out of reach of children.

Monitoring Requirements

Assess for cardiac conduction risk and consider baseline ECG (and repeat after titration) in patients with known conduction disease, structural heart disease, syncope, or on PR‑prolonging drugs; monitor for suicidal ideation/behavior and CNS adverse effects (dizziness, ataxia); check renal and hepatic function at baseline and periodically as clinically indicated.

Pharmacology

Mechanism of Action

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

Onset of Action

Pharmacokinetic onset: peak plasma concentration occurs about 1-4 hours after an oral dose; clinical seizure control improvement is typically assessed over days to weeks as the dose is titrated to an effective maintenance dose.

Duration of Effect

Approximately 12 hours per dose, supporting twice‑daily administration.

Half-Life

Approximately 13 hours.

Bioavailability

Approximately 100% (oral bioavailability).

Metabolism

Limited metabolism; mainly demethylation to inactive O-desmethyl-lacosamide, mediated primarily by CYP2C19 with contributions from CYP3A4 and CYP2C9; lacosamide is not a clinically significant CYP inducer/inhibitor.

Protein Binding

Less than 15%

Product Information

Available Dosage Forms

Film‑coated tablet; oral solution; solution for intravenous infusion (injection).

Composition per Dose

Each film-coated tablet: 200mg lacosamide

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Also Used For

Partial-onset seizures; primary generalized tonic-clonic seizures

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 23-08-2026