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Keppra Injection

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Keppra Injection

Indications
Dosage
How Supplied

INDICATIONS

Partial Onset Seizures

KEPPRA is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. KEPPRA injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.

Myoclonic Seizures In Patients With Juvenile Myoclonic Epilepsy

KEPPRA 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. KEPPRA injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.

Primary Generalized Tonic-Clonic Seizures

KEPPRA 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. KEPPRA injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.

DOSAGE AND ADMINISTRATION

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.

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.

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 KEPPRA, the initial total daily intravenous dosage of KEPPRA should be equivalent to the total daily dosage and frequency of oral KEPPRA.

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.

Preparation And Administration Instructions

KEPPRA 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. KEPPRA injection should be administered as a 15-minute IV infusion. One vial of KEPPRA 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 KEPPRA injection vial contents should be discarded.

Adults

See Table 1 for the recommended preparation and administration of KEPPRA injection for adults to achieve a dose of 500 mg, 1000 mg, or 1500 mg.

Table 1: Preparation and Administration of KEPPRA Injection for Adults

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 in 100 mL of a compatible diluent and administer intravenously as a 15-minute infusion.

Pediatric Patients

When using KEPPRA injection for pediatric patients, dosing is weight-based (mg per kg).

The following calculation should be used to determine the appropriate daily dose of KEPPRA injection for pediatric patients:

Total daily dose (mL/day) = Daily dose (mg/kg/day) x patient weight (kg) /100 mg/mL

Dosage Adjustments In Adult Patients With Renal Impairment

KEPPRA dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults with renal impairment are shown in Table 2. 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:

Males: (weight in kg) x (140 – age)
(72) x serum creatinine (mg/100 mL)
Females (0.85) x (above value)

Then CLcr is adjusted for body surface area (BSA) as follows:

CLcr (mL/min/1.73m2)= CLcr (mL/min) x 1.73
BSA subject (m2)

Table 2: Dosage Adjustment Regimen for Adult Patients with Renal Impairment

Group Creatinine Clearance (mL/min/1.73m²) Dosage (mg) Frequency
Normal > 80 500 to 1,500 Every 12 hours
Mild 50 - 80 500 to 1,000 Every 12 hours
Moderate 30 - 50 250 to 750 Every 12 hours
Severe < 30 250 to 500 Every 12 hours
ESRD patients using dialysis - 500 to 1,0001 Every 24 hours1
1Following dialysis, a 250 to 500 mg supplemental dose is recommended.

Compatibility And Stability

KEPPRA injection 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 (5986°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 with antiepileptic drugs that are not listed above.

HOW SUPPLIED

Dosage Forms And Strengths

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

Storage And Handling

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 manufactured for UCB, Inc. Smyrna, GA 30080. Revised: Oct 2014

Last reviewed on RxList: 11/13/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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