VALES 500/MG FC TAB 30/FC TAB

Indications

Approved Uses

Adjunctive therapy for partial-onset seizures in patients aged 1 month and older, myoclonic seizures in patients 12 years and older with Juvenile Myoclonic Epilepsy, and primary generalized tonic-clonic seizures in patients 6 years and older with idiopathic generalized epilepsy.

Off-Label Uses

Status epilepticus (IV levetiracetam as an off‑label/adjunct option in many protocols); other proposed off‑label uses (e.g., migraine, neuropathic pain, mood disorders) have weaker/variable evidence and are not standard.

Dosage & Administration

Dosing by Condition

Adults (IR): Partial-onset seizures, juvenile myoclonic epilepsy (≥12 years), and primary generalized tonic‑clonic seizures (≥12 years): start 500 mg twice daily; increase by 500 mg twice daily every 2 weeks as needed; usual maintenance 1000-3000 mg/day (max 1500 mg twice daily).

Initial Dose

500 mg twice daily (1000 mg/day)

Maintenance Dose

1000-3000 mg/day in two divided doses

Maximum Dose

3000 mg per day.

Children's Dosage

1 month to <6 months: 7 mg/kg twice daily (max 21 mg/kg twice daily); 6 months to <4 years: 10 mg/kg twice daily (max 25 mg/kg twice daily); 4 to <16 years: 10 mg/kg twice daily (max 30 mg/kg twice daily); For tablets (≥20 kg): weight-based or 500 mg twice daily increasing to 1500 mg twice daily

Dose Adjustment Notes

Renal dose adjustment is required based on creatinine clearance; no adjustment is usually needed for mild-moderate hepatic impairment, but in severe hepatic impairment (Child‑Pugh C) reduce the maintenance dose by ~50% because renal clearance may be reduced; titration is typically in 500 mg twice-daily increments every 2 weeks as tolerated/needed.

How to Take

Swallow the 500 mg film‑coated tablet whole with water; may be taken with or without food; take at the same times each day, typically in 2 divided doses (every ~12 hours) for immediate‑release levetiracetam.

Side Effects

Common Side Effects

Somnolence, dizziness, asthenia/fatigue, headache; behavioral/psychiatric effects (irritability, agitation, aggression, mood changes); decreased appetite; nausea/vomiting; nasopharyngitis/upper respiratory tract infection.

Side Effect Frequency

Very common (≥10%): somnolence, headache, nasopharyngitis. Common (1-10%): dizziness, fatigue/asthenia, irritability/nervousness, depression/anxiety, insomnia, decreased appetite (anorexia), tremor, vertigo/balance disturbance, nausea/vomiting/diarrhea/abdominal pain/dyspepsia, rash. Uncommon/rare: aggression/hostility, psychosis/hallucinations, suicidal ideation/behavior, hematologic abnormalities (e.g., thrombocytopenia/leukopenia), alopecia, severe hypersensitivity/serious skin reactions.

Safety & Warnings

Contraindications

Known hypersensitivity to levetiracetam or other pyrrolidone derivatives.

Warnings & Precautions

Monitor for mood/behavior changes and suicidality; do not discontinue abruptly; adjust dose in renal impairment; watch for severe rash/hypersensitivity (SJS/TEN/DRESS) and for hematologic abnormalities; use caution in patients with psychiatric history.

Age Restriction

Levetiracetam is approved for pediatric use from 1 month of age for certain seizure types, but this 500 mg film‑coated tablet is generally appropriate only for children able to swallow tablets (commonly ≥6 years and/or ≥20 kg); younger children typically require oral solution/other suitable formulations.

Driving Warning

May Cause Drowsiness

Drug Interactions

Interaction Severity

Most interactions are pharmacodynamic: CNS depressants (including alcohol, benzodiazepines, opioids) can cause additive sedation/dizziness-generally considered moderate; levetiracetam has minimal clinically significant pharmacokinetic drug-drug interactions.

Food Interaction

No clinically significant food restriction; may be taken with or without food (food may delay Tmax but does not meaningfully reduce extent of absorption).

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Children

1 month to <6 months: 7 mg/kg twice daily (max 21 mg/kg twice daily); 6 months to <4 years: 10 mg/kg twice daily (max 25 mg/kg twice daily); 4 to <16 years: 10 mg/kg twice daily (max 30 mg/kg twice daily); For tablets (≥20 kg): weight-based or 500 mg twice daily increasing to 1500 mg twice daily

Elderly

Start at a lower dose and titrate slowly. Dose adjustment is recommended based on renal function, which can be decreased in the elderly.

Kidney Impairment

CrCl >80 mL/min: 500-1500 mg every 12h; CrCl 50-80 mL/min: 500-1000 mg every 12h; CrCl 30-50 mL/min: 250-750 mg every 12h; CrCl <30 mL/min: 250-500 mg every 12h; End-stage renal disease on dialysis: 500-1000 mg every 24h, with 250-500 mg supplemental dose after dialysis

Liver Impairment

No adjustment for mild-moderate hepatic impairment; in severe hepatic impairment (Child‑Pugh C) reduce the maintenance dose by ~50% (and base dosing on renal function/CrCl).

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule; do not double doses.

Stopping the Medicine

Do not stop abruptly; taper gradually (individualized-commonly over at least 2-4 weeks, longer if clinically indicated) to reduce risk of increased seizure frequency/status epilepticus.

Overdose

Symptoms: somnolence, agitation/aggression, decreased consciousness, respiratory depression/coma; management: urgent medical evaluation, supportive care/airway protection, consider activated charcoal if early, and hemodialysis can remove ~50% of levetiracetam in 4 hours.

Patient Counseling

Take levetiracetam (VALES) exactly as prescribed (often twice daily) at the same times each day; may be taken with or without food. Swallow tablets with water. Do not stop suddenly-taper only under prescriber direction to avoid seizure worsening. If a dose is missed, take it when remembered unless it is close to the next dose; do not double. May cause dizziness/somnolence-avoid driving/operating machinery until effects are known; avoid or limit alcohol and other sedatives. Report new/worsening mood or behavior changes (irritability, aggression, depression), suicidal thoughts, or unusual behavior promptly. Tell your clinician if pregnant/planning pregnancy or breastfeeding, and inform them of kidney disease (dose may need adjustment). Keep follow-up appointments and do not change brand/formulation without advice.

Monitoring Requirements

No routine therapeutic drug level monitoring is required; monitor clinical response and adverse effects (especially mood/behavior/suicidality), and assess renal function at baseline and periodically (and when clinical status changes) to guide dosing; CBC/LFTs only if clinically indicated.

Pharmacology

Mechanism of Action

Binds to synaptic vesicle protein SV2A, modulating neurotransmitter release and reducing neuronal hyperexcitability (exact downstream mechanisms not fully defined).

Duration of Effect

Immediate‑release levetiracetam provides clinical coverage for about 12 hours per dose, supporting twice‑daily dosing; elimination half‑life is ~6-8 hours in adults.

Half-Life

About 6-8 hours in adults with normal renal function (prolonged in renal impairment and in older adults).

Bioavailability

Approximately 100% (essentially complete; often reported as ≥95%).

Metabolism

Minimal hepatic metabolism; main pathway is enzymatic hydrolysis of the acetamide group to an inactive metabolite (non-CYP; not dependent on CYP450).

Product Information

Available Dosage Forms

Immediate-release film-coated tablet (oral)

Composition per Dose

Each film-coated tablet contains: 500mg Levetiracetam

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Also Used For

Partial onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy, primary generalized tonic-clonic seizures

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