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Levetiracetam Injection

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Levetiracetam Injection Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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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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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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4 CONTRAINDICATIONS

Levetiracetam injection is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see...

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5 WARNINGS AND PRECAUTIONS

5.1 Behavioral Abnormalities and Psychotic Symptoms

Levetiracetam may cause behavioral abnormalities and psychotic symptoms. Patients...

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6 ADVERSE REACTIONS

The following adverse reactions are discussed in more details in other sections of labeling:

  • Behavioral Abnormalities and Psychotic Symptoms [see

    6.1...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Exposure Registry

There is a...

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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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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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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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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis...

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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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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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17 PATIENT COUNSELING INFORMATION

Psychiatric Reactions and Changes in Behavior

Advise patients and their caregivers that levetiracetam may...

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Manufactured by:
Gland Pharma Limited,
Hyderabad 500043, India.

Manufactured for:
Hospira, Inc.
Lake Forest, IL 60045 USA

...

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