KEPPRA 1000MG 30TAB

Indications

Approved Uses

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

Off-Label Uses

Common off‑label uses include status epilepticus (IV or oral loading/maintenance per institutional protocols) and seizure prophylaxis in select settings (e.g., neurosurgical/traumatic brain injury) where used by local guidelines.

Dosage & Administration

Dosing by Condition

Immediate‑release (oral) adjunct/monotherapy where applicable: (1) Partial‑onset seizures (adults and adolescents ≥16 years): start 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to 1500 mg twice daily (max 3000 mg/day). (2) Myoclonic seizures (≥12 years): start 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to 1500 mg twice daily (3000 mg/day). (3) Primary generalized tonic‑clonic seizures: adults and children ≥6 years-adults start 500 mg twice daily and titrate by 500 mg twice daily every 2 weeks to 1500 mg twice daily; pediatrics use weight‑based dosing per labeling (e.g., 10 mg/kg twice daily initially with titration to recommended targets).

Initial Dose

500mg twice daily (1000mg/day)

Maintenance Dose

1000 mg to 3000 mg daily, divided into two doses.

Maximum Dose

3000 mg per day.

Children's Dosage

Children 1 month to <6 months: 7mg/kg twice daily, up to 21mg/kg twice daily; Children 6 months to <4 years: 10mg/kg twice daily, up to 25mg/kg twice daily; Children 4 to <16 years: 10mg/kg twice daily, up to 30mg/kg twice daily; Adolescents ≥16 years: adult dosing applies

Dose Adjustment Notes

Renal dose adjustment is required based on creatinine clearance; no adjustment is generally needed for mild-moderate hepatic impairment, but in severe hepatic impairment (Child‑Pugh C) the maintenance dose should be reduced by ~50% when CrCl is <60 mL/min/1.73 m²; titration is typically in 500 mg twice‑daily steps at ~2‑week intervals as tolerated/needed.

Side Effects

Common Side Effects

Somnolence, asthenia/fatigue, dizziness, headache, irritability/behavioral changes (including aggression), and decreased appetite; upper respiratory infection/nasopharyngitis can also occur.

Side Effect Frequency

Very common (>10%): somnolence, asthenia/fatigue (and commonly headache). Common (1-10%): dizziness, headache, irritability/behavioral symptoms (e.g., aggression), nausea/vomiting, diarrhea, anorexia, infection/nasopharyngitis.

Safety & Warnings

Warnings & Precautions

Monitor for mood/behavior changes and suicidality; caution with somnolence/dizziness (driving/operating machinery); do not discontinue abruptly; adjust for renal impairment; be alert for severe skin reactions (SJS/TEN) and DRESS; consider monitoring for hematologic abnormalities if clinically indicated, especially with symptoms/infection/bleeding.

Age Restriction

Levetiracetam is approved from 1 month of age for partial-onset seizures (age/indication dependent); the 1000 mg film‑coated tablet is generally intended for patients able to swallow tablets (typically older children/adolescents and adults), while younger infants/children usually use oral solution with weight-based dosing.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Few clinically significant pharmacokinetic interactions; main clinically relevant interactions are additive CNS depression with alcohol/other sedatives, and notable reports include reduced methotrexate clearance (monitor levels/toxicity) and probenecid affecting the inactive metabolite (usually not clinically important).

Interaction Severity

Clinically relevant interactions are mainly pharmacodynamic: additive CNS depression with alcohol and other sedatives (e.g., benzodiazepines, opioids) - 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 exposure).

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Children

Children 1 month to <6 months: 7mg/kg twice daily, up to 21mg/kg twice daily; Children 6 months to <4 years: 10mg/kg twice daily, up to 25mg/kg twice daily; Children 4 to <16 years: 10mg/kg twice daily, up to 30mg/kg twice daily; Adolescents ≥16 years: adult dosing applies

Elderly

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

Kidney Impairment

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

Liver Impairment

No dose adjustment for mild-moderate hepatic impairment; in severe hepatic impairment, dose should be based on renal function and CrCl may be overestimated-reduce dose when renal function is reduced (commonly: if CrCl <60 mL/min/1.73 m², start at ~50% of usual).

Storage & Patient Advice

Patient Counseling

Take exactly as prescribed twice daily at consistent times, with or without food; swallow tablets with water and do not stop abruptly without medical advice; may cause dizziness/somnolence-avoid driving/operating machinery until effects are known; avoid or limit alcohol and other sedatives due to additive CNS effects; report mood/behavior changes, depression, aggression, 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; assess renal function at baseline and periodically in elderly or renal impairment for dose selection/adjustment; monitor for mood/behavior changes and suicidality; CBC only if clinically indicated (e.g., symptoms/signs of hematologic abnormality).

Pharmacology

Mechanism of Action

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

Onset of Action

After oral immediate‑release dosing, peak plasma concentration occurs about 1 hour (approximately 1-1.3 hours); clinical antiseizure benefit may begin soon after initiation but is assessed over days as dosing is stabilized.

Duration of Effect

Immediate‑release levetiracetam is dosed twice daily, providing clinical coverage of roughly 12 hours per dose; elimination half‑life is about 6-8 hours in adults.

Half-Life

Approximately 6-8 hours in adults (longer in elderly/renal impairment)

Bioavailability

Approximately 100% (essentially complete oral bioavailability)

Metabolism

Minimal metabolism; primarily enzymatic hydrolysis of the acetamide group to an inactive metabolite (not CYP450-mediated)

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 intravenous injection/infusion solution; an extended‑release tablet also exists in some markets but is a different product from this immediate‑release film‑coated tablet.

Composition per Dose

Each film-coated tablet: 1000mg levetiracetam

Generic Availability

Yes

Also Used For

Partial Onset Seizures, Myoclonic Seizures, Primary Generalized Tonic-Clonic Seizures

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