Levetiracetam
LEVETIRACETAM- levetiracetam injection
WG Critical Care, LLC
1 INDICATIONS AND USAGE
1.1 Partial-Onset Seizures
Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy.
1.4 Limitations of Use
Levetiracetam in Sodium Chloride Injection is an antiepileptic drug indicated for adult patients (16 years and older) when oral administration is temporarily not feasible.
2 DOSAGE AND ADMINISTRATION
2.1 General Information – Administration
Levetiracetam in Sodium Chloride Injection is for intravenous infusion only. It is available in the following concentrations: one single-dose 50 mL bag of levetiracetam (250 mg [5 mg/mL]) and three single-dose 100 mL bags, each containing a different total dosage of levetiracetam (500 mg [5 mg/mL], 1000 mg [10 mg/mL], or 1500 mg [15 mg/mL]).
A single-dose bag should be administered intravenously over a 15-minute IV infusion period.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Levetiracetam in Sodium Chloride Injection should not be further diluted prior to use. Any unused portion of the Levetiracetam in Sodium Chloride Injection contents should be discarded.
2.2 Initial Exposure to Levetiracetam
Levetiracetam can be initiated with either intravenous or oral administration.
Partial-Onset Seizures
In clinical trials of oral levetiracetam, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)] , a consistent increase in response with increased dose has not been shown.
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. Doses greater than 3000 mg/day have been used in open-label studies with levetiracetam tablets for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased 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.
Primary Generalized Tonic-Clonic Seizures
Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased 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.
2.3 Switching to Intravenous 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.
2.4 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.
2.5 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 Table 1. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in mL/min is needed.
| |||
Group | Creatinine Clearance (mL/min) | Dosage (mg) | Frequency |
Normal | greater than 80 | 500 to 1,500 | Every 12 hours |
Mild | 50 to 80 | 500 to 1,000 | Every 12 hours |
Moderate | 30 to 50 | 250 to 750 | Every 12 hours |
Severe | less than 30 | 250 to 500 | Every 12 hours |
ESRD patients using dialysis | —- | 500 to 1,000 | *Every 24 hours |
2.6 Compatibility With Other Antiepileptic Drugs
Levetiracetam in Sodium Chloride Injection is found to be physically compatible and chemically stable for at least 24 hours when mixed with lorazepam, diazepam, and valproate sodium and stored at controlled room temperature 15°C to 30°C (59°F to 86°F).
There are no data to support the physical compatibility of levetiracetam injection with antiepileptic drugs that are not listed above.
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