VALES 100MG/ML ORAL SOLUTION

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.

Dosage & Administration

Dosing by Condition

Adults (adjunct or monotherapy depending on indication): start 500 mg twice daily; may increase by 500 mg twice daily every 2 weeks to a usual max of 1500 mg twice daily (3000 mg/day) for partial‑onset, myoclonic, and primary generalized tonic‑clonic seizures; pediatrics are weight‑based (commonly starting ~10 mg/kg twice daily and titrating to ~30 mg/kg twice daily, with younger infants starting lower).

Initial Dose

Adults (≥16 years): 500 mg twice daily (1000 mg/day total).

Maintenance Dose

Adults (≥16 years): 1000 mg to 3000 mg per day, administered in two divided doses.

Maximum Dose

3000 mg/day (adults); 60 mg/kg/day (children ≤50 kg)

Children's Dosage

Dosing is weight-based and varies by age. 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. [4, 6]

Dose Adjustment Notes

Dose adjustment is required in renal impairment based on creatinine clearance; in severe hepatic impairment (Child‑Pugh C) with reduced renal function, a ~50% reduction of the daily maintenance dose is recommended; titration for seizure control is typically in 500 mg twice‑daily increments at ~2‑week intervals (clinical practice/label).

How to Take

Oral use; may be taken with or without food; measure the prescribed dose of the oral solution accurately using an oral syringe/calibrated measuring device and swallow directly (may be diluted in a small amount of water if needed); administer at the same times each day (typically twice daily for immediate‑release levetiracetam).

How to Prepare

No reconstitution required; ready-to-use oral solution-shake if directed by the product labeling and measure doses with an oral syringe/measuring device.

Safety & Warnings

Warnings & Precautions

Monitor for behavioral changes/depression/suicidality; caution with somnolence/dizziness and impaired coordination (driving/falls); adjust dose in renal impairment; avoid abrupt discontinuation; watch for hypersensitivity/SCAR and clinically significant blood dyscrasias.

Age Restriction

Approved from 1 month of age for the oral solution (levetiracetam); tablet/capsule formulations are typically labeled from 4 years depending on indication/product labeling.

Driving Warning

May Cause Drowsiness

Drug Interactions

Food Interaction

No clinically significant food restriction; may be taken with or without food (food may delay Tmax slightly without meaningful effect on extent of absorption).

Special Populations

Children

Dosing is weight-based and varies by age. 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. [4, 6]

Elderly

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

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 (supplemental dose of 250-500 mg after dialysis recommended)

Storage & Patient Advice

Preparation Instructions

No reconstitution required; ready-to-use oral solution-shake if directed by the product labeling and measure doses with an oral syringe/measuring device.

Patient Counseling

Take levetiracetam oral solution exactly as prescribed (usually twice daily) with or without food; use an oral syringe/measuring device for accurate dosing. 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. Report mood/behavior changes, worsening depression, aggression/irritability, or suicidal thoughts immediately. Store below 30°C and keep out of reach of children.

Pharmacology

Duration of Effect

Immediate‑release levetiracetam provides clinical coverage with twice‑daily dosing; adult elimination half‑life is ~6-8 hours (longer in renal impairment).

Product Information

Available Dosage Forms

Levetiracetam is available as immediate‑release oral tablets, oral solution, and intravenous injection/infusion solution (some markets also have extended‑release tablets).

Composition per Dose

Each 1 ml: 100 mg levetiracetam

Generic Availability

Yes

Also Used For

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

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 09-05-2026