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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
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.
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.
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.
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.
This image is provided by the National Library of Medicine.
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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Levetiracetam (injection) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Levetiracetam (injection) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Levetiracetam (injection) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Levetiracetam (injection) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Levetiracetam (injection) in pediatric patients.
Contraindications
There is limited information regarding Levetiracetam (injection) Contraindications in the drug label.
Warnings
There is limited information regarding Levetiracetam (injection) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Levetiracetam (injection) in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Levetiracetam (injection) in the drug label.
Drug Interactions
There is limited information regarding Levetiracetam (injection) Drug Interactions in the drug label.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Levetiracetam (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Levetiracetam (injection) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Levetiracetam (injection) with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Levetiracetam (injection) with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Levetiracetam (injection) with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Levetiracetam (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Levetiracetam (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Levetiracetam (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Levetiracetam (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Levetiracetam (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Levetiracetam (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
Intravenous
Monitoring
There is limited information regarding Monitoring of Levetiracetam (injection) in the drug label.
Description
IV Compatibility
There is limited information regarding IV Compatibility of Levetiracetam (injection) in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Levetiracetam (injection) in the drug label.
Pharmacology
There is limited information regarding Levetiracetam (injection) Pharmacology in the drug label.