LEVETAM XR 500/MG ER FC TAB 30/TAB

Indications

Approved Uses

Adjunctive therapy for partial-onset seizures; adjunctive therapy for myoclonic seizures in juvenile myoclonic epilepsy; adjunctive therapy for primary generalized tonic-clonic seizures in idiopathic generalized epilepsy (age ranges depend on local label).

Off-Label Uses

Common off-label uses include treatment of status epilepticus (IV levetiracetam) and seizure prophylaxis in neurocritical care settings (e.g., traumatic brain injury, subarachnoid hemorrhage, post-neurosurgery).

Dosage & Administration

Dosing by Condition

XR (adults): partial-onset seizures-start 1000 mg once daily, increase by 1000 mg every 2 weeks to max 3000 mg/day; myoclonic seizures and primary generalized tonic-clonic seizures-typical target up to 3000 mg/day with similar titration (per label/guidelines; pediatric dosing is weight/age-based per local label).

Initial Dose

1000 mg once daily

Maintenance Dose

1000-3000 mg/day once daily

Maximum Dose

3000 mg per day.

Children's Dosage

Extended-release tablets are approved for children 12 years of age and older for partial-onset seizures. Dosing for other formulations varies by age and weight.

Dose Adjustment Notes

Adjust dose based on renal function (CrCl) and titrate based on response/tolerability; when discontinuing, taper gradually to reduce risk of increased seizure frequency.

How to Take

Swallow LEVETAM XR (extended-release levetiracetam) tablets whole with liquid; do not crush, chew, or split; may be taken once daily with or without food.

Side Effects

Common Side Effects

Somnolence, dizziness, fatigue/asthenia, headache, irritability and other behavioral symptoms (e.g., aggression), decreased appetite; infections/nasopharyngitis may occur.

Side Effect Frequency

Very common (>10%): somnolence, headache. Common (1-10%): dizziness, fatigue/asthenia, irritability/nervousness, infection (e.g., nasopharyngitis), decreased appetite/anorexia, depression, hostility/aggression, anxiety, insomnia, tremor, vertigo, nausea/vomiting, abdominal pain/diarrhea/dyspepsia, rash.

Safety & Warnings

Contraindications

Hypersensitivity to levetiracetam or any excipients (including prior anaphylaxis/angioedema); hypersensitivity to other pyrrolidone derivatives is commonly included as a precaution/extension in labeling.

Warnings & Precautions

Monitor for suicidality and mood/behavior changes; risk of somnolence/dizziness and impaired coordination; do not discontinue abruptly (taper); adjust dose in renal impairment; rare serious skin reactions and hypersensitivity (incl. DRESS); possible hematologic abnormalities-consider CBC if clinically indicated.

Age Restriction

Extended-release levetiracetam (XR) is generally indicated for patients ≥12 years; not recommended/approved for <12 years for this dosage form.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Clinically significant pharmacokinetic interactions are uncommon; additive CNS depression with alcohol/other sedatives is relevant; probenecid can reduce renal clearance of the inactive metabolite; methotrexate clearance may be reduced (monitor).

Interaction Severity

Clinically relevant interactions are limited; additive CNS depression with alcohol and other sedatives/CNS depressants (caution). Probenecid can increase exposure to the inactive metabolite; methotrexate has been reported to have reduced clearance with levetiracetam (monitor if co-administered).

Food Interaction

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

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Children

Extended-release tablets are approved for children 12 years of age and older for partial-onset seizures. Dosing for other formulations varies by age and weight.

Elderly

Dose adjustment based on renal function (CrCl); start at lower end of dosing range and titrate carefully; monitor renal function regularly

Kidney Impairment

For XR (once daily) adjust by CrCl: ≥80 mL/min: 1000-3000 mg q24h; 50-79: 1000-2000 mg q24h; 30-49: 500-1500 mg q24h; <30: 500-1000 mg q24h; ESRD on dialysis: 500-1000 mg q24h with a supplemental 250-500 mg after dialysis.

Liver Impairment

No adjustment for mild-moderate hepatic impairment; for severe hepatic impairment, reduce maintenance dose by ~50% only when there is concomitant renal impairment (i.e., reduced creatinine clearance).

Storage & Patient Advice

Missed Dose

Take as soon as remembered. If it is almost time for the next dose, skip the missed dose and continue with the regular schedule. Do not take a double dose.

Stopping the Medicine

Do not stop abruptly; taper gradually (individualize-commonly over at least 1-2 weeks or longer depending on seizure control and dose).

Overdose

Symptoms: somnolence, agitation/aggression, depressed consciousness, respiratory depression, coma; management: supportive care, consider GI decontamination if early, and hemodialysis can enhance removal.

Patient Counseling

Swallow XR tablets whole (do not crush/chew/split); take once daily at the same time; do not stop abruptly-taper with prescriber guidance; may cause dizziness/somnolence-avoid driving/machinery until effects known; avoid or limit alcohol and other sedatives; report mood/behavior changes or suicidal thoughts promptly; inform provider if pregnant/planning/breastfeeding and keep follow-up for renal function and response.

Monitoring Requirements

Monitor seizure control and adverse effects; assess renal function (CrCl) at baseline and periodically (especially elderly/renal impairment); monitor for mood/behavior changes and suicidal ideation; CBC if clinically indicated (e.g., unexplained weakness, fever, recurrent infections).

Pharmacology

Mechanism of Action

Binds to synaptic vesicle protein SV2A, modulating neurotransmitter release and reducing neuronal hyperexcitability; the full mechanism is not completely understood.

Onset of Action

XR Tmax is about 4 hours; steady state is reached in ~2 days; clinical seizure reduction may be seen early but is individualized.

Duration of Effect

Approximately 24 hours (supports once-daily dosing for the XR formulation).

Half-Life

Approximately 6-8 hours in adults with normal renal function; prolonged in renal impairment and often ~10-11 hours in the elderly

Bioavailability

Approximately 100% (essentially complete oral bioavailability)

Metabolism

Minimal metabolism; primarily non-hepatic enzymatic hydrolysis of the acetamide group to an inactive metabolite; not CYP450-dependent

Excretion

Primarily renal: ~66% excreted unchanged in urine and ~24-27% as an inactive metabolite (with only a small fraction in feces)

Protein Binding

<10%.

Product Information

Available Dosage Forms

Immediate-release tablet, extended-release tablet, oral solution, injectable solution, tablet for oral suspension.

Composition per Dose

Each extended-release tablet: 500 mg levetiracetam

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Psych Class

Antiepileptic Drug

Controlled Substance

No

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