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Levetiracetam Injection
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
Levetiracetam Injection Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Partial-Onset Seizures
Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Dosing for Partial-Onset Seizures
The recommended dosing for monotherapy and adjunctive therapy is the same as outlined below.
...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
One single-dose vial of levetiracetam injection contains 500 mg levetiracetam (500 mg/5 mL) as a clear, colorless solution.
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Contraindications
4 CONTRAINDICATIONS
Levetiracetam injection is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Behavioral Abnormalities and Psychotic Symptoms
Levetiracetam may cause behavioral abnormalities and psychotic symptoms. Patients...
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Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions are discussed in more details in other sections of labeling:
- Behavioral Abnormalities and Psychotic Symptoms [see...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Exposure Registry
There is a...
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Overdosage
10 OVERDOSAGE
10.1 Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans
The highest known dose of oral levetiracetam received in the clinical...
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Description
11 DESCRIPTION
Levetiracetam injection, USP is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration.
The chemical name of levetiracetam, a single enantiomer...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The precise mechanism(s) by which levetiracetam exerts its antiepileptic effect is unknown.
A saturable and...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis...
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Clinical Studies
14 CLINICAL STUDIES
All clinical studies supporting the efficacy of levetiracetam utilized oral formulations. The finding of efficacy of levetiracetam injection is based on the results of studies using an oral formulation of...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Levetiracetam injection, USP 500 mg/5 mL injection is a clear, colorless, sterile solution. It is supplied in...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Psychiatric Reactions and Changes in Behavior
Advise patients and their caregivers that levetiracetam may...
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.