Indication
Levetiracetam is indicated as an adjunctive therapy for-
? Partial Onset Seizures
? Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
? Primary Generalized Tonic-Clonic Seizures
Dosage & Administration
Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg.
Use in Pediatric Patients
Age/weight | Initial dose (Daily) | Incremental dose (Daily) |
1 Month To < 6 Months | 7 mg/kg twice daily | 21 mg/kg twice daily |
6 Months To < 4 Years | 10 mg/kg twice daily | 25 mg/kg twice daily |
4 Years To < 16 Years | 10 mg/kg twice daily | 30 mg/kg twice daily |
Adolescent with 20 - 40 kg body weight | 250 mg twice daily | 750 mg twice daily |
*The daily dose should be increased every 2 weeks.
Levetira Oral Solution: Weight-Based Dosing Calculation for Pediatric Patients:
Total daily dose (ml/day) = | Daily dose (mg/kg/day) x patient weight (kg) 100 mg/ml |
Adult Patients with Impaired Renal Function
Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in the following table-
Dosing Adjustment Regimen for Adult Patients with Impaired Renal
Function
Group
| Creatinine Clearance (ml/min.)
| Dosage (mg) | Frequency |
Normal
| >80
| 500 to 1500 | Every 12 h |
Mild
| 50 - 80 | 500 to 1000 | Every 12 h |
Moderate
| 30 - 50 | 250 to 750 | Every 12 h |
Severe
| < 30 | 250 to 500 | Every 12 h |
Patients Using Dialysis
|
| 500 to 1000 | Every 24 h* |
*Following dialysis, a 250 to 500 mg supplemental dose is
recommended.
Use in Pregnancy and Lactation
Pregnancy: Pregnancy category C.
Lactation: No data on the use of Levetiracetam in breast-feeding women
are available. Data from animals indicate that Levetiracetam is secreted
into milk. Therefore, Levetiracetam is contraindicated during
breast-feeding.
Precautions
Severe allergic reactions, abnormal thoughts, dark urine, decreased coordination, extreme dizziness, drowsiness, tiredness, or weakness, fever, chills, persistent sore throat, hallucinations, memory loss, mouth sores, muscle or neck pain, new or worsening mental problem, mood or behavior changes, new or worsening seizures, pain, suicidal thoughts or attempts, unusual bruising or bleeding, vision changes, yellowing of the skin or eyes.
