Levetiracetam

Preview FDA label, Bionpharma Inc., oral, effective 2026-04-17. Full label on DailyMed

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.

Dosing in kidney impairment

Dosage Adjustments in Adult Patients with Renal Impairment Levetiracetam oral solution dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated.

To do this an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula: [See table below.] Then CLcr is adjusted for body surface area (BSA) as follows: [See table below.] [See table below.]

CLcr= [140-age (years)] × weight (kg) (× 0.85 for female patients)
72 × serum creatinine (mg/dL)
CLcr (mL/min/1.73m 2)= CLcr (mL/min) × 1.73
BSA subject (m 2)
Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment
GroupCreatinine Clearance (mL/min/1.73m 2) Dosage (mg)Frequency
Normal> 80500 to 1,500Every 12 hours
Mild50 to 80500 to 1,000Every 12 hours
Moderate30 to 50250 to 750Every 12 hours
Severe< 30250 to 500Every 12 hours
ESRD patients using dialysis—500 to 1,000 Following dialysis, a 250 mg to 500 mg supplemental dose is recommended.Every 24 hours

Preparation and administration

Important Administration Instructions Levetiracetam oral solution is given orally with or without food. The levetiracetam oral solution dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function. Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg.

Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg. When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).