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Click on icon to see table/diagram/imageDosage in children and adolescents ≥50 kg is the same as in adults. (See Table 8.)
Click on icon to see table/diagram/imageA 750-mg loading dose is recommended on the 1st day of treatment with Levetiracetam.
Following dialysis, a 250- to 500-mg supplemental dose is recommended.
Taken orally, swallowed with a sufficient quantity of liquid and may be taken with or without food. The daily dose is administered in 2 equally divided doses.
Monotherapy: Adults and Adolescents from 16 years: Recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after 2 weeks. The dose can be further increased by 250 mg twice daily every 2 weeks depending upon the clinical response. The maximum dose is 1500 mg twice daily.
Add-on therapy: Adults (>18 years) and Adolescents (12-17 years) of ≥50 kg: Initial Therapeutic Dose: 500 mg twice daily. This dose can be started on the 1st day of treatment.
Depending upon the clinical response and tolerance, the daily dose can be increased up to 1500 mg twice daily. Dose changes can be made in 500 mg twice-daily increases or decreases every 2-4 weeks.
Elderly (≥65 years): Adjustment of the dose is recommended in elderly patients with compromised renal function.
Children 4-11 years and Adolescents 12-17 years weighing <50 kg: The initial therapeutic dose is 10 mg/kg twice daily. Depending upon the clinical response and tolerability, the dose can be increased up to 30 mg/kg twice daily. Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every 2 weeks. The lowest effective dose should be used. Dosage in children ≥50 kg is the same as in adults. The physician should prescribe the most appropriate pharmaceutical form and strength according to weight and dose.
Infants and Children <4 years: Levetiracetam is not recommended for use in children <4 years due to insufficient data on safety and efficacy.
Patients with Renal Impairment: The daily dose must be individualized according to renal function. For adult patient, refer to Table 2 and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed. The CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula: (See Equation 2 as follows.)
For children with renal impairment, Levetiracetam dose needs to be adjusted based on the renal function as levetiracetam clearance is related to renal function. This recommendation is based on a study in adult renally impaired patients.
Patients with Hepatic Impairment: No dose adjustment is needed with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the creatinine clearance may underestimate the renal insufficiency. Therefore, a 50% reduction of the daily maintenance dose is recommended when the creatinine is <70 mL/min.
Lepixa: Oral solution: Monotherapy for adults and adolescents from 16 years of age: The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. The maximum dose is 1500 mg twice daily.
Add-on therapy for adults (18 years) and adolescents (12 to 17 years) weighing 50 kg or more: The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment.
Depending upon the clinical response and tolerability, the daily dose can be increased up to 1,500 mg twice daily. Dose changes can be made in 500 mg twice daily increases or decreases every two to four weeks.
Hepatic impairment: No dose adjustment is needed in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the creatinine clearance may underestimate the renal insufficiency. Therefore a 50% reduction of the daily maintenance dose is recommended when the creatinine clearance is <60 ml/min/1.73 m2.
Paediatric Population: The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to weight and dose.
The safety and efficacy of Levetiracetam Oral Solution concentrate for solution for infusion in infants and children less than 4 years have not been established.
Monotherapy: The safety and efficacy of Levetiracetam Oral Solution in children and adolescents below 16 years as monotherapy treatment have not been established.
There are no data available.
Add-on therapy for infants aged from 6 to 23 months, children (2 to 11 years)and adolescents (12 to 17 years) weighing less than 50 kg: The initial therapeutic dose is 10mg/kg twice daily.
Depending upon the clinical response and tolerability, the dose can be increased up to 30 mg/kg twice daily. Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two weeks. The lowest effective dose should be used.
Dose in children 50 kg or greater is the same as in adults.
Dose recommendations for infants from 6 months of age, children and adolescents: (See Table 9).
Click on icon to see table/diagram/imageAdd-on therapy for infants from 1 month to less than 6 months: The tablet formulation is not adapted for use in infants under the age of 6 months. The oral solution is the formulation to use in infants.
The initial therapeutic dose is 7 mg/kg twice daily.
Infants should start the treatment with Levetiracetam Oral Solution 100 mg/ml oral solution.
Dose recommendations for infants less than 6 months: (See Table 10).
Click on icon to see table/diagram/imageThis presentation should be prescribed for children older than 4 years, adolescents and adults.
A 150 ml bottle with graduated oral syringe containing up to 300 mg levetiracetam (corresponding to 3 ml) with a graduation every 0.1 ml (corresponding to 10 mg).
In order to ensure the accuracy of the dosing, the smaller bottle (150 ml) and syringe graduated from 0.1 to 3 ml per graduation of 0.1 ml should be prescribed for infants older than 6 months and young children.
A 150 ml bottle with graduated oral syringe containing up to 100 mg levetiracetam (corresponding to 1 ml) with a graduation every 0.05 ml (corresponding to 5 mg).
In order to ensure the accuracy of the dosing, the smaller bottle (150 ml) and syringe graduated from 0.05 to 1 ml per graduation of 0.05 ml should be prescribed for infants less than 6 months.
Method of Administration: The oral solution may be diluted in a glass of water and may be taken with or without food. A graduated oral syringe, an adaptor for the syringe and instructions for use in the package leaflet are provided with Levetiracetam Oral Solution 100 mg/mL.
The daily dose is administered in two equally divided doses.
Solution for injection: 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.
Pediatric Patients: 1 Month to <6 Months: Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.
6 Months to <4 Years: Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.
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.
Dosing for Myoclonic Seizures in Patients 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 (10 mg/kg twice daily) 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.
Switching from Oral Dosing: When switching from oral Levetiracetam, the initial total daily intravenous dosage of Levetiracetam should be equivalent to the total daily dosage and frequency of oral Levetiracetam.
Switching to Oral Dosing: At the end of the intravenous treatment period, the patient may be switched to Levetiracetam oral administration at the equivalent daily dosage and frequency of the intravenous administration.
Preparation and Administration Instructions: Levetiracetam injection is for intravenous use only and should be diluted in 100 mL of a compatible diluent prior to administration. If a smaller volume is required (e.g. pediatric patients), the amount of diluent should be calculated to not exceed a maximum levetiracetam concentration of 15 mg per mL of diluted solution. Consideration should also be given to the total daily fluid intake of the patient. Levetiracetam injection should be administered as a 15-minute IV infusion. One vial of Levetiracetam injection contains 500 mg levetiracetam (500 mg/5 mL).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Product with particulate matter or discoloration should not be used.
Any unused portion of the Levetiracetam injection vial contents should be discarded.
Adults: See Table 11 for the recommended preparation and administration of Levetiracetam injection for adults to achieve a dose of 500 mg, 1000 mg, or 1500 mg. (See Table 11.)
Click on icon to see table/diagram/imageFor example, to prepare a 1000 mg dose, dilute 10 mL of Levetiracetam injection in 100 mL of a compatible diluent and administer intravenously as a 15-minute infusion.
Pediatric Patients: When using Levetiracetam injection for pediatric patients, dosing is weight-based (mg per kg). The following calculation should be used to determine the appropriate daily dose of Levetiracetam injection for pediatric patients: (See Equation 1.)
Click on icon to see table/diagram/imageDosage Adjustments in Adult Patients with Renal Impairment: Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults with renal impairment are shown in Table 12. Information is unavailable for dosage adjustments in pediatric patients with renal impairment. In order to calculate the dose recommended for adult 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 Equations 2 and 3).
Then CLcr is adjusted for body surface area (BSA) as follows: (See Equation 2).
Click on icon to see table/diagram/imageThen CLcr is adjusted for body surface area (BSA) as follows: (See Equation 3 and Table 12).
Click on icon to see table/diagram/image
Click on icon to see table/diagram/image
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