Information about Vetra
The composition:
Each film coated tablet contains: levetiracetam 250 mg or 500 mg or 1000 mg.
Pharmacokinetics:
Absorption of levetiracetam is rapid, with peak plasma concentrations occurring in about an hour following oral administration in fasted subjects. The oral bioavailability of levetiracetam tablets is 100% and the tablets and oral solution are bioequivalent in rate and extent of absorption. Food does not affect the extent of absorption of levetiracetam but it decreases c max by 20% and delays t max by 1.5 hours.
Indications:
Partial onset seizures:
Levetiracetam indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.
Myoclonic seizures in patients with juvenile myoclonic epilepsy:
Levetiracetam is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
Primary generalized tonic-clonic seizures:
Levetiracetam is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
Dosage and administration:
Levetiracetam is given orally with or without food.
The dosing regimen depends on the indication, age group, dosage form, and renal function.
Prescribe the oral solution for pediatric patients with body weight ≤ 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).
Dosing for partial onset seizures:
*Adults 16 years and older:
Initiate treatment 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. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
*4 years to < 16 years:
Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced.
In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.
For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).
For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).
Dosing for myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy:
Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily).
Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.
Dosing for primary generalized tonic-clonic seizures:
*Adults 16 years and older:
Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily).
Increase dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.
*Pediatric patients ages 6 to <16 years:
Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. 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.
Pregnancy:
pregnancy category c
Nursing mothers:
Levetiracetam is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from levetiracetam, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Storage conditions:
Store below 30°c.
Packaging:
Carton pack of 30 film coated tablets.