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.

Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function
*
Following dialysis, a 250 mg to 500 mg supplemental dose is recommended.

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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