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Keppra Injection

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Keppra Injection

Indications
Dosage
How Supplied

INDICATIONS

KEPPRA injection (levetiracetam) is an alternative for adult patients (16 years and older) when oral administration is temporarily not feasible.

Partial Onset Seizures

KEPPRA is indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy.

Myoclonic Seizures In Patients With Juvenile Myoclonic Epilepsy

KEPPRA is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy.

Primary Generalized Tonic-Clonic Seizures

KEPPRA is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy.

DOSAGE AND ADMINISTRATION

General Information

KEPPRA injection (levetiracetam) is for intravenous use only and must be diluted prior to administration. KEPPRA injection (levetiracetam) (500 mg/5 mL) should be diluted in 100 mL of a compatible diluent [see DOSAGE AND ADMINISTRATION] and administered intravenously as a 15-minute IV infusion.

Product with particulate matter or discoloration should not be used.

Any unused portion of the KEPPRA injection (levetiracetam) vial contents should be discarded.

Initial Exposure To KEPPRA

KEPPRA can be initiated with either intravenous or oral administration.

Partial Onset Seizures

In clinical trials of oral KEPPRA, 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], 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 KEPPRA 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 BID). 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.

Replacement Therapy

When switching from oral KEPPRA, the initial total daily intravenous dosage of KEPPRA should be equivalent to the total daily dosage and frequency of oral KEPPRA and should be administered as a 15-minute intravenous infusion following dilution in 100 mL of a compatible diluent.

Switching To Oral Dosing

At the end of the intravenous treatment period, the patient may be switched to KEPPRA oral administration at the equivalent daily dosage and frequency of the intravenous administration.

Dosing Instructions

KEPPRA injection (levetiracetam) is for intravenous use only and must be diluted prior to administration. One vial of KEPPRA injection contains 500 mg levetiracetam (500 mg/5 mL). See Table 1 for the recommended preparation and administration of KEPPRA injection to achieve a dose of 500 mg, 1000 mg, or 1500 mg.

Table 1: Preparation And Administration Of KEPPRA Injection (levetiracetam)

Dose Withdraw Volume Volume of Diluent Infusion Time
500 mg 5 mL (5 mL vial) 100 mL 15 minutes
1000 mg 10 mL (two 5 mL vials) 100 mL 15 minutes
1500 mg 15 mL (three 5 mL vials) 100 mL 15 minutes

For example, to prepare a 1000 mg dose, dilute 10 mL of KEPPRA injection (levetiracetam) in 100 mL of a compatible diluent [see DOSAGE AND ADMINISTRATION] and administer intravenously as a 15-minute infusion.

Adult Patients With Impaired Renal Function

KEPPRA dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 2. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

CLcr = [140-age (years)] x weight (kg) x 1 0.85
72 x serum creatinine (mg/dL)
1.For female patients

Table 2: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function

Group Creatinine Clearance (mL/min) Dosage (mg) Frequency
Normal > 80 500 to 1,500 Every 12 h
Mild 50 - 80 500 to 1,000 Every 12 h
Moderate 30 - 50 250 to 750 Every 12 h
Severe < 30 250 to 500 Every 12 h
ESRD patients using dialysis - 500 to 1,000 1Every 24 h
1 Following dialysis, a 250 to 500 mg supplemental dose is recommended.

Compatibility And Stability

KEPPRA injection (levetiracetam) was found to be physically compatible and chemically stable when mixed with the following diluents and antiepileptic drugs for at least 24 hours and stored in polyvinyl chloride (PVC) bags at controlled room temperature 15-30°C (59-86°F).

Diluents

Sodium chloride (0.9%) injection, USP
Lactated Ringer's injection
Dextrose 5% injection, USP

Other Antiepileptic Drugs

Lorazepam
Diazepam
Valproate sodium

There is no data to support the physical compatibility of KEPPRA injection (levetiracetam) with antiepileptic drugs that are not listed above.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

HOW SUPPLIED

Dosage Forms And Strengths

One vial of KEPPRA injection contains 500 mg levetiracetam (500 mg/5 mL).

KEPPRA (levetiracetam) 500 mg/5 mL injection is a clear, colorless, sterile solution. It is supplied in single-use 5 mL vials, available in cartons of 10 vials (NDC 50474-002-63).

Storage

Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F) [see USP Controlled Room Temperature].

KEPPRA injection (levetiracetam) manufactured for UCB, Inc. Smyrna, GA 30080. FDA Rev date: 05/16/08

Last reviewed on RxList: 8/25/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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