Levetiracetam (injection)

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Levetiracetam (injection)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

Levetiracetam (injection) is an anticonvulsant that is FDA approved for the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures. Common adverse reactions include somnolence, asthenia, infection, dizziness,fatigue, aggression, nasal congestion, decreased appetite, and irritability.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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

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.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


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.

Mechanism of Action

Structure

File:Levetiracetam (injection)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Levetiracetam (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Levetiracetam (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Levetiracetam (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Levetiracetam (injection) in the drug label.

How Supplied

Storage

There is limited information regarding Levetiracetam (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Levetiracetam (injection) in the drug label.

Precautions with Alcohol

  • Alcohol-Levetiracetam (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "levetiracetam injection, solution, concentrate".
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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