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Levetiracetam Injection Index Section

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Partial-Onset Seizures

1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy

1.3 Primary Generalized Tonic-Clonic Seizures

1.4 Limitations of Use

2 DOSAGE AND ADMINISTRATION

2.1 Dosing for Partial-Onset Seizures

2.2 Dosing for Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy

2.3 Dosing for Primary Generalized Tonic-Clonic Seizures

2.4 Switching from Oral Dosing

2.5 Switching to Oral Dosing

2.6 Preparation and Administration Instructions

2.7 Dosage Adjustments in Adult Patients with Renal Impairment

2.8 Discontinuation of Levetiracetam

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Behavioral Abnormalities and Psychotic Symptoms

5.2 Somnolence and Fatigue

5.3 Anaphylaxis and Angioedema

5.4 Serious Dermatological Reactions

5.5 Coordination Difficulties

5.6 Withdrawal Seizures

5.7 Hematologic Abnormalities

5.8 Increase in Blood Pressure

5.9 Seizure Control During Pregnancy

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

10 OVERDOSAGE

10.1 Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans

10.2 Management of Overdose

10.3 Hemodialysis

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Partial-Onset Seizures

14.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy

14.3 Primary Generalized Tonic-Clonic Seizures

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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