What are the guidelines for the administration of Levetiracetam (Keppra) in pediatric patients?

From the Guidelines

Levetiracetam is recommended for pediatric patients at a starting dose of 10 mg/kg twice daily, with a maximum daily dose of 60 mg/kg/day, and can be administered intravenously at 20-60 mg/kg (maximum 4500 mg) over 15 minutes for acute seizure management, as supported by the most recent study 1. The administration of levetiracetam in pediatric patients should be guided by the most recent and highest quality evidence available.

Key Considerations

• The starting dose for children is typically 10 mg/kg twice daily, which can be gradually increased to 20-30 mg/kg twice daily based on clinical response 1.
• In neonates and infants under 4 years, a three-times-daily dosing schedule may be preferred due to the shorter half-life in this age group 1.
• The maximum recommended daily dose is 60 mg/kg/day, though doses up to 100 mg/kg/day have been used in some refractory cases 1.
• Levetiracetam is available in oral solution (100 mg/mL), tablets (250,500,750, and 1000 mg), extended-release tablets, and intravenous formulation (100 mg/mL) 1.

Administration and Monitoring

• For acute seizure management, IV levetiracetam can be administered at 20-60 mg/kg (maximum 4500 mg) over 15 minutes 1.
• Common side effects include irritability, behavioral changes, somnolence, and dizziness, which are generally less severe than with older antiepileptic drugs 1.
• Regular monitoring should include assessment of behavior, mood changes, and seizure frequency, though routine blood monitoring is not typically required 1.

Special Considerations

• Patients with CNS disease or a history of seizures may benefit from anti-seizure prophylaxis with levetiracetam (10 mg/kg, up to a maximum of 500 mg per dose) every 12 hours for 30 days following infusion 1.
• Neurology consultation should be considered if the patient develops grade 1 CRES (Table 3) and/or for specialized screening for papilloedema 1.

From the FDA Drug Label

DOSAGE AND ADMINISTRATION Levetiracetam is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Pediatric Patients Ages 4 To <16 Years Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15: Levetiracetam Tablet Weight-Based Dosing Guide For Children Patient WeightDaily Dose 20 mg/kg/day(BID dosing)40 mg/kg/day(BID dosing)60 mg/kg/day(BID dosing) 20. 1 to 40 kg500 mg/day(1 × 250 mg tablet BID)1000 mg/day(1 × 500 mg tablet BID)1500 mg/day(1 × 750 mg tablet B ID)

40 kg1000 mg/day(1 × 500 mg tablet BID)2000 mg/day(2 × 500 mg tablets BID)3000 mg/day(2 × 750 mg tablets BID)

The guidelines for the administration of Levetiracetam (Keppra) in pediatric patients are as follows:

• Initial dose: 20 mg/kg/day in 2 divided doses (10 mg/kg BID) for patients aged 4 to <16 years
• Dose increments: Increase every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID)
• Dosing for patients with body weight ≤20 kg: Oral solution
• Dosing for patients with body weight above 20 kg: Either tablets or oral solution
• Tablet dosing guide: Provided in Table 15 based on weight during titration to 60 mg/kg/day 2

From the Research

Administration Guidelines for Levetiracetam in Pediatric Patients

• The dosage of levetiracetam for children should be 130 to 140% of those advised for adults 3.
• The range of final daily dose was 10-71 mg/kg/day, with a mean of 29.5 mg/kg/day 4.
• In the study by 5, the doses of levetiracetam tested were 60 mg/kg/day in children.
• Levetiracetam is effective against partial and generalized epilepsy, with the percentage of responders reaching 64%, and 8 to 23% seizure free 3.
• The drug has also proven effective against photosensitivity and epileptic and nonepileptic myoclonus 3.

Monitoring and Safety

• Clinical pharmacokinetic monitoring (CPM) of levetiracetam is not recommended for routine use in pediatric patients with epilepsy, but may be beneficial in select cases 6.
• The most common adverse events were behavioral problems such as aggression and irritability 4.
• The discontinuation rate due to adverse events was 2.5%, and due to inefficacy was 5.3% 4.
• Somnolence was the most common adverse effect, affecting 13% of participants, and it was significantly associated with levetiracetam compared to placebo 5.

Efficacy in Specific Conditions

• Levetiracetam is effective for absence epilepsy, but only about one-quarter of children with absence epilepsy became seizure free with levetiracetam 7.
• When effective, levetiracetam can control absence epilepsy at a relatively low dose 7.
• Levetiracetam had a positive effect on some aspects of cognition and quality of life (QoL) in adults and worsened certain aspects of child behavior 5.