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Levetiracetam Injection
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Levetiracetam Injection Quick Finder
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...
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.
...
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.
4 CONTRAINDICATIONS
Levetiracetam injection is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see...
5 WARNINGS AND PRECAUTIONS
5.1 Behavioral Abnormalities and Psychotic Symptoms
Levetiracetam may cause behavioral abnormalities and psychotic symptoms. Patients...
6 ADVERSE REACTIONS
The following adverse reactions are discussed in more details in other sections of labeling:
- Behavioral Abnormalities and Psychotic Symptoms [see...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Exposure Registry
There is a...
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...
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...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The precise mechanism(s) by which levetiracetam exerts its antiepileptic effect is unknown.
A saturable and...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis...
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...
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...
17 PATIENT COUNSELING INFORMATION
Psychiatric Reactions and Changes in Behavior
Advise patients and their caregivers that levetiracetam may...
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