EPITAM 500 MG 30TAB

Indications

Approved Uses

Adjunctive therapy for partial-onset seizures in patients 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 (including as an IV second‑line option after benzodiazepines) is a common off‑label use; other proposed off‑label uses (e.g., migraine prophylaxis, neuropathic pain, mood disorders) have weaker/variable evidence and are not standard.

Dosage & Administration

Dosing by Condition

Adults (immediate‑release tablets) for partial‑onset, myoclonic (JME ≥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 effective range 1000-3000 mg/day; maximum 3000 mg/day (1500 mg twice daily).

Initial Dose

500 mg twice daily (1000 mg/day)

Maintenance Dose

1000 mg to 3000 mg per day, administered 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 <12 years: 10 mg/kg twice daily, max 30 mg/kg twice daily; 12-17 years: 500 mg twice daily, max 1500 mg twice daily (oral solution preferred for young children)

Dose Adjustment Notes

Renal dose adjustment is required based on creatinine clearance; in severe hepatic impairment, dose adjustment is generally driven by reduced renal function (e.g., if CrCl <60 mL/min, reduce maintenance accordingly) rather than an automatic 50% reduction solely for Child‑Pugh C; titration is typically in 500 mg twice‑daily increments every ~2 weeks based on response/tolerability.

How to Take

Swallow the 500 mg film‑coated tablet whole with water; may be taken with or without food; for immediate‑release levetiracetam tablets the total daily dose is typically given in 2 divided doses (morning and evening) as prescribed.

Side Effects

Common Side Effects

Somnolence, dizziness, asthenia/fatigue, headache; behavioral/psychiatric effects (irritability, agitation/aggression, mood changes, depression/anxiety); gastrointestinal upset (nausea, vomiting, diarrhea); nasopharyngitis/upper respiratory symptoms and decreased appetite can occur.

Side Effect Frequency

Very common (≥10%): somnolence, asthenia/fatigue, headache. Common (1-10%): dizziness, irritability/behavioral changes (including aggression), depression/anxiety, insomnia, nausea/vomiting, diarrhea, decreased appetite (anorexia), rash; coordination problems (e.g., ataxia/vertigo) may occur. Rare/uncommon but serious: suicidal ideation/psychosis, severe cutaneous reactions (e.g., SJS/TEN), blood dyscrasias (e.g., leukopenia/thrombocytopenia).

Safety & Warnings

Contraindications

Hypersensitivity to levetiracetam or other pyrrolidone derivatives.

Warnings & Precautions

Key precautions: monitor for behavioral/psychiatric changes and suicidality; avoid abrupt withdrawal (taper); adjust/monitor in renal impairment; caution with somnolence/coordination impairment (driving/operating machinery); watch for serious skin reactions and hypersensitivity; consider monitoring CBC if clinically indicated.

Age Restriction

Levetiracetam is approved for pediatric use from 1 month of age for certain seizure types, but this EPITAM 500 mg film‑coated tablet is practically appropriate only for patients able to swallow tablets (commonly ≥6 years); younger children typically require an oral solution.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Levetiracetam has no clinically significant CYP-mediated pharmacokinetic interactions; key considerations are additive CNS depression with sedatives/alcohol and a clinically important interaction with methotrexate (possible reduced MTX clearance/toxicity)-monitor closely if co-administered.

Interaction Severity

CNS depressants (alcohol, benzodiazepines, opioids): additive sedation/impairment-typically managed as a moderate clinical interaction; probenecid can increase exposure to the inactive metabolite (usually not clinically significant); methotrexate interaction (reduced clearance/increased toxicity) has been reported and warrants caution/monitoring; levetiracetam has minimal clinically relevant pharmacokinetic interactions with other antiepileptics.

Food Interaction

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

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

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 <12 years: 10 mg/kg twice daily, max 30 mg/kg twice daily; 12-17 years: 500 mg twice daily, max 1500 mg twice daily (oral solution preferred for young children)

Elderly

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

Kidney Impairment

Adult renal adjustment (immediate‑release): CrCl >80 mL/min: 500-1500 mg q12h; CrCl 50-80: 500-1000 mg q12h; CrCl 30-50: 250-750 mg q12h; CrCl <30: 250-500 mg q12h; ESRD on dialysis: 500-1000 mg q24h plus 250-500 mg supplemental after dialysis.

Liver Impairment

No dose adjustment is needed in mild-moderate hepatic impairment; in severe hepatic impairment, dose adjustment is based on renal function (reduce initial dose by ~50% if CrCl <60 mL/min).

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-commonly over at least 2 weeks (often 2-4 weeks depending on dose, seizure control, and clinical context).

Overdose

Symptoms may include somnolence, agitation/aggression, decreased consciousness, respiratory depression, and coma; management is supportive (airway/ventilation as needed), consider activated charcoal if early, and hemodialysis can enhance removal.

Patient Counseling

Take levetiracetam exactly as prescribed (often twice daily) at the same times each day; may be taken with or without food. Do not stop suddenly-taper only under prescriber guidance 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 and limit/avoid alcohol. Report mood/behavior changes (irritability, depression, suicidal thoughts) promptly. Store in the blister and do not store above 30°C; keep out of reach of children.

Monitoring Requirements

Monitor for behavioral/psychiatric adverse effects (including depression/suicidal ideation) and somnolence; assess renal function at baseline and periodically in elderly or renal impairment (dose adjust by CrCl); routine therapeutic drug monitoring is not required.

Pharmacology

Mechanism of Action

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

Onset of Action

Pharmacokinetic onset: peak plasma concentration occurs about 1 hour after an oral immediate‑release dose; clinical seizure control may be observed early but is typically assessed over days to weeks as dosing is optimized.

Duration of Effect

Clinical dosing interval is about 12 hours for immediate‑release tablets (supports twice‑daily administration); elimination half‑life is ~6-8 hours in adults with normal renal function.

Half-Life

About 6-8 hours in adults with normal renal function; prolonged in renal impairment and often in the elderly.

Bioavailability

Approximately 100% (near-complete oral bioavailability).

Metabolism

Minimal hepatic metabolism; main pathway is enzymatic hydrolysis of the acetamide group (non-CYP) to an inactive metabolite.

Excretion

Primarily renal: ~66% excreted unchanged in urine; most of the remainder is excreted renally as an inactive metabolite (overall ~90-95% recovered in urine).

Protein Binding

<10% protein binding.

Product Information

Available Dosage Forms

For this SFDA product: film‑coated tablet (oral). In general levetiracetam is also available in oral solution and IV concentrate/solution for infusion; extended‑release tablets exist in some markets but are not implied by this specific SFDA listing.

Composition per Dose

Each film-coated tablet: 500 mg levetiracetam

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Also Used For

Approved for partial onset seizures, myoclonic seizures in juvenile myoclonic epilepsy, primary generalized tonic-clonic seizures.

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