KEPPRA 100/MG/ML ORAL SOLUTION 300ML

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. Monotherapy for partial-onset seizures in patients 16 years and older.

Dosage & Administration

Dosing by Condition

Adults (IR, adjunct or mono where indicated): Partial-onset seizures: start 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to max 1500 mg twice daily. Juvenile myoclonic epilepsy (≥12 years): start 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to max 1500 mg twice daily. Primary generalized tonic-clonic seizures (≥6 years per many labels; adolescents/adults commonly cited): start 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to max 1500 mg twice daily. Pediatrics (partial-onset): 4-16 years: start 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to max 30 mg/kg twice daily; 1 month-<4 years: start 7 mg/kg twice daily; increase by 7 mg/kg twice daily every 2 weeks to max 21 mg/kg twice daily.

Initial Dose

500mg twice daily (adults); 10mg/kg twice daily (children 4-16 years)

Maintenance Dose

1000-3000mg/day in two divided doses (adults)

Maximum Dose

3000mg/day (adults); 60mg/kg/day (children)

Children's Dosage

Dosing is weight-based and varies by age and indication. For partial-onset seizures: 1 to <6 months: 7 mg/kg twice daily, up to 21 mg/kg twice daily. 6 months to <4 years: 10 mg/kg twice daily, up to 25 mg/kg twice daily. 4 to <16 years: 10 mg/kg twice daily, up to 30 mg/kg twice daily.

Dose Adjustment Notes

Adjust dose in renal impairment based on creatinine clearance; no adjustment is generally needed for mild-moderate hepatic impairment, but in severe hepatic impairment with reduced renal function (e.g., CrCl <60 mL/min/1.73 m²) a ~50% reduction of the daily maintenance dose is recommended; titration is typically in 2-week intervals as clinically needed.

How to Take

Oral use; administer twice daily (approximately 12 hours apart) with or without food; measure each dose with a calibrated oral syringe/measuring device (do not use a household spoon); may be taken directly or diluted in a small amount of water/soft food and taken immediately; do not stop abruptly.

How to Prepare

Ready-to-use oral solution; no reconstitution required. Shake gently if instructed by the product label and measure with the supplied dosing device.

Side Effects

Common Side Effects

Somnolence, asthenia/fatigue, dizziness, headache, irritability/behavioral changes (including aggression), nasopharyngitis/infection, decreased appetite, and gastrointestinal upset (nausea/vomiting/diarrhea).

Side Effect Frequency

Very common (≥10%): somnolence, asthenia/fatigue, headache, nasopharyngitis. Common (1-10%): dizziness, irritability/nervousness, aggression/hostility, depression/anxiety, insomnia, anorexia, tremor, vertigo, balance disorder, nausea, vomiting, diarrhea, abdominal pain/dyspepsia, rash. Uncommon/rare: psychotic symptoms/hallucinations, suicidal ideation/behavior, blood dyscrasias (e.g., leukopenia, thrombocytopenia), alopecia.

Safety & Warnings

Warnings & Precautions

Monitor for behavioral/psychiatric changes and suicidality; risk of severe skin reactions (SJS/TEN/DRESS); avoid abrupt discontinuation; adjust dose in renal impairment; consider monitoring CBC if clinically indicated; oral solution excipients (e.g., maltitol) may be relevant in hereditary fructose intolerance.

Age Restriction

Partial-onset seizures: ≥1 month of age; Myoclonic seizures (JME): ≥12 years; Primary generalized tonic-clonic seizures (idiopathic generalized epilepsy): ≥6 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Clinically important interactions are limited; additive CNS depression with alcohol/other sedatives is possible; probenecid can increase the inactive metabolite (not parent drug) by reducing renal tubular secretion; methotrexate: possible reduced clearance/increased MTX toxicity-monitor; oral contraceptives: no clinically significant interaction.

Interaction Severity

Clinically relevant interactions are mainly pharmacodynamic: additive CNS depression with alcohol, opioids, benzodiazepines and other sedatives (generally moderate; counsel to avoid/limit alcohol). Probenecid can increase exposure to the inactive metabolite (usually not clinically significant). No clinically significant interaction with combined oral contraceptives; antacids are not a meaningful interaction.

Food Interaction

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

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Children

Dosing is weight-based and varies by age and indication. For partial-onset seizures: 1 to <6 months: 7 mg/kg twice daily, up to 21 mg/kg twice daily. 6 months to <4 years: 10 mg/kg twice daily, up to 25 mg/kg twice daily. 4 to <16 years: 10 mg/kg twice daily, up to 30 mg/kg twice daily.

Elderly

Start at a lower dose and titrate slowly. Dose adjustment is recommended based on renal function, as creatinine clearance decreases with age.

Kidney Impairment

CrCl 50-79 mL/min: 500-1000 mg q12h; CrCl 30-49 mL/min: 250-750 mg q12h; CrCl <30 mL/min: 250-500 mg q12h; ESRD on dialysis: 500-1000 mg q24h plus 250-500 mg supplemental dose after dialysis.

Liver Impairment

No adjustment for mild-moderate hepatic impairment; in severe hepatic impairment, reduce maintenance dose by ~50% only if there is concomitant renal impairment (e.g., CrCl <60 mL/min).

Storage & Patient Advice

Preparation Instructions

Ready-to-use oral solution; no reconstitution required. Shake gently if instructed by the product label and measure with the supplied dosing device.

Stopping the Medicine

Do not stop abruptly - taper gradually over a minimum of 2 weeks to reduce the risk of increased seizure frequency.

Overdose

Symptoms: somnolence, agitation/aggression, decreased consciousness, respiratory depression, coma; Management: supportive care/airway protection, consider GI decontamination if early, no antidote; hemodialysis removes ~50% of levetiracetam over 4 hours.

Patient Counseling

Take levetiracetam oral solution exactly as prescribed (often twice daily) at the same times each day; measure doses only with the provided oral syringe/measuring device. Do not stop suddenly-taper only under prescriber direction to avoid seizure worsening. If you miss a dose, take it as soon as remembered unless it is close to the next dose; do not double. May cause dizziness/somnolence-avoid driving/operating machinery until you know your response; limit/avoid alcohol and other sedatives. Report new or worsening mood/behavior changes (irritability, aggression), depression, or suicidal thoughts immediately. Keep follow-up appointments; dose adjustments are commonly needed in kidney impairment and during pregnancy-discuss pregnancy planning/contraception and inform your clinician if pregnant. Store below 30°C and keep out of reach of children.

Monitoring Requirements

Monitor seizure control and adverse effects; monitor for neuropsychiatric symptoms (behavioral changes, depression, suicidality); assess renal function at baseline and periodically (and for dose adjustment), especially in older adults or renal impairment; routine serum drug levels are not required; CBC only if clinically indicated.

Pharmacology

Mechanism of Action

Binds to synaptic vesicle protein SV2A, modulating neurotransmitter release and reducing neuronal hyperexcitability; additional proposed effects (e.g., modulation of calcium currents and inhibitory neurotransmission) are secondary and not fully established clinically.

Onset of Action

Pharmacokinetic onset: peak plasma concentration occurs about 1 hour after oral solution (may be delayed with food); clinical seizure reduction can occur early but is typically assessed over days to weeks during titration.

Duration of Effect

Approximately 12 hours per immediate-release dose, supporting twice-daily administration.

Half-Life

6-8 hours in adults; 5-7 hours in children.

Bioavailability

Approximately 100% (essentially complete) oral bioavailability.

Metabolism

Minimal metabolism; primary pathway is enzymatic hydrolysis of the acetamide group to an inactive metabolite (non-CYP), with no clinically relevant CYP450 involvement.

Excretion

Predominantly renal: ~66% excreted unchanged in urine; ~24% excreted as the inactive carboxylic acid metabolite; total urinary recovery is ~90-95%.

Protein Binding

<10%.

Product Information

Available Dosage Forms

Immediate-release film-coated tablets, oral solution, and intravenous injection/concentrate for solution for infusion; extended-release tablets also exist in some markets but are a different product from this oral solution.

Composition per Dose

Each 1 mL: 100mg levetiracetam

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Also Used For

Partial onset seizures, Myoclonic seizures in JME, Primary generalized tonic-clonic seizures in idiopathic generalized epilepsy

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