KEPPRA 500/MG FC TAB 30/FC TAB

Indications

Approved Uses

Adjunctive therapy for partial-onset seizures in patients from one month of age, adjunctive therapy for myoclonic seizures in patients from 12 years of age with Juvenile Myoclonic Epilepsy, adjunctive therapy for primary generalized tonic-clonic seizures in patients from 6 years of age with Idiopathic Generalized Epilepsy, and monotherapy for partial-onset seizures in patients from 16 years of age.

Off-Label Uses

Common off‑label uses include treatment of status epilepticus (IV or oral loading/maintenance in protocols) and seizure prophylaxis in select settings (e.g., traumatic brain injury/neurosurgical patients), depending on institutional guidelines.

Dosage & Administration

Dosing by Condition

Adults (immediate‑release tablets): Partial‑onset seizures-start 500 mg twice daily, increase by 500 mg twice daily every 2 weeks as needed; usual range 1,000-3,000 mg/day. Myoclonic seizures (JME, ≥12 years) and Primary generalized tonic‑clonic seizures (≥6 years)-start 500 mg twice daily, increase every 2 weeks to 1,500 mg twice daily (max 3,000 mg/day). Pediatrics: weight‑based dosing is used (e.g., ~10 mg/kg twice daily initially with titration), per age/weight and product labeling.

Initial Dose

500mg twice daily (1000mg/day)

Maintenance Dose

1000-3000mg per day in two divided doses

Maximum Dose

3000 mg per day.

Children's Dosage

Partial-onset seizures (1 month to <6 months): Initial 7 mg/kg twice daily, up to 21 mg/kg twice daily. (6 months to <4 years): Initial 10 mg/kg twice daily, up to 25 mg/kg twice daily. (4 to <16 years): Initial 10 mg/kg twice daily, up to 30 mg/kg twice daily.

Dose Adjustment Notes

Adjust dose in renal impairment based on creatinine clearance; when discontinuing, taper gradually to reduce risk of increased seizure frequency; hepatic adjustment is generally not required, except consider lower doses in severe hepatic impairment when renal function is also reduced.

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, administer in 2 divided doses (typically twice daily) at consistent times.

Side Effects

Common Side Effects

Common adverse effects include somnolence, asthenia/fatigue, dizziness, headache, irritability/behavioral changes (including aggression), and decreased appetite; nasopharyngitis/upper respiratory symptoms can occur.

Side Effect Frequency

Very common (≥10%): somnolence, asthenia/fatigue, headache, nasopharyngitis. Common (1-10%): dizziness, irritability/behavioral changes (including aggression/hostility), depression/anxiety, anorexia, tremor, balance disorder/ataxia, nausea/vomiting, abdominal pain/diarrhea/dyspepsia, rash.

Safety & Warnings

Contraindications

Hypersensitivity to levetiracetam or other pyrrolidone derivatives.

Warnings & Precautions

Monitor for behavioral/psychiatric symptoms and suicidality; caution with somnolence/fatigue and activities requiring alertness; adjust for renal impairment; avoid abrupt discontinuation (taper); watch for severe skin reactions/DRESS and hypersensitivity; consider monitoring CBC if clinically indicated.

Age Restriction

Levetiracetam is approved for use from 1 month of age for certain seizure types (typically as oral solution); film‑coated tablets are generally used only in children who can safely swallow tablets (commonly ≥6 years, product/formulation dependent).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Additive CNS depression with alcohol/other sedatives; otherwise few clinically significant pharmacokinetic interactions (notably: probenecid increases exposure to the inactive metabolite; methotrexate-reports of reduced clearance/toxicity-monitor if coadministered).

Interaction Severity

Clinically relevant interactions are mainly pharmacodynamic: alcohol and other CNS depressants can increase sedation/impairment (generally moderate). Levetiracetam has minimal clinically significant pharmacokinetic drug-drug interactions (including with oral contraceptives).

Food Interaction

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

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Caution

Children

Partial-onset seizures (1 month to <6 months): Initial 7 mg/kg twice daily, up to 21 mg/kg twice daily. (6 months to <4 years): Initial 10 mg/kg twice daily, up to 25 mg/kg twice daily. (4 to <16 years): Initial 10 mg/kg twice daily, up to 30 mg/kg twice daily.

Elderly

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

Kidney Impairment

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 post-dialysis.

Liver Impairment

No adjustment for mild-moderate hepatic impairment; in severe hepatic impairment, reduce dose only if renal function is also impaired (i.e., base dosing on renal function and consider ~50% reduction of the renal-adjusted maintenance dose when severe hepatic disease is accompanied by reduced CrCl).

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly - taper gradually over a minimum of 2 weeks to reduce the risk of withdrawal seizures.

Overdose

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

Patient Counseling

Take exactly as prescribed (typically twice daily for immediate‑release tablets) with or without food; swallow tablets whole; do not stop abruptly-taper with prescriber guidance; may cause dizziness/somnolence-avoid driving until effects are known; avoid or limit alcohol/CNS depressants due to additive sedation; report mood/behavior changes or suicidal thoughts promptly; if a dose is missed, take it when remembered unless near the next dose-do not double.

Monitoring Requirements

No routine serum drug-level monitoring is required; monitor clinically for seizure control and adverse effects (especially mood/behavioral changes and suicidality) and assess renal function for dosing (baseline and periodically or when clinical status changes).

Pharmacology

Mechanism of Action

Binds to synaptic vesicle protein SV2A, modulating neurotransmitter release and reducing neuronal hyperexcitability; additional effects on ion currents have been described but the primary established mechanism is SV2A binding.

Onset of Action

Pharmacokinetic onset: peak plasma concentration occurs about ~1 hour after an immediate‑release oral dose; clinical seizure improvement may be seen early but is individualized and depends on titration and baseline seizure frequency.

Duration of Effect

Immediate‑release levetiracetam provides clinical coverage with twice‑daily dosing; elimination half‑life is ~6-8 hours, supporting a ~12‑hour dosing interval.

Half-Life

Adults: ~6-8 hours; shorter in children and longer in the elderly and in renal impairment.

Bioavailability

Approximately 100% (essentially complete oral bioavailability).

Metabolism

Minimal metabolism; primarily enzymatic hydrolysis of the acetamide group (non-CYP) to an inactive metabolite.

Excretion

Primarily renal: ~66% excreted unchanged in urine; ~24% as inactive metabolite; total urinary recovery ~90-95%.

Protein Binding

<10%.

Product Information

Available Dosage Forms

Levetiracetam is available as immediate‑release tablets (including film‑coated), oral solution, and IV solution for injection/infusion; an extended‑release tablet also exists (Keppra XR in the US), but it is a different formulation from this SFDA film‑coated tablet product.

Composition per Dose

Each film-coated tablet: 500mg levetiracetam

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Also Used For

Partial-onset seizures, Myoclonic seizures in juvenile myoclonic epilepsy, Primary generalized tonic-clonic seizures

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