Label: LEVETIRACETAM- levetiracetam tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 21, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Partial-Onset Seizures - Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Administration Instructions - Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Levetiracetam tablets, USP 250 mg are white, oblong shape film-coated functionally scored tablets debossed with 'SG 470' on scored side and plain on other side. Levetiracetam tablets, USP 500 mg ...
  • 4 CONTRAINDICATIONS
    Levetiracetam tablets are contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema - [see Warnings and Precautions ( 5.4) ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Behavioral Abnormalities and Psychotic Symptoms - Levetiracetam may cause behavioral abnormalities and psychotic symptoms. Patients treated with levetiracetam should be monitored for ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in more details in other sections of labeling: Behavior Abnormalities and Psychotic Symptoms - [see Warnings and Precautions ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including levetiracetam ...
  • 10 OVERDOSAGE
    10.1 Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans - The highest known dose of levetiracetam received in the clinical development program was 6,000 mg/day. Other than ...
  • 11 DESCRIPTION
    Levetiracetam is an antiepileptic drug available as 250mg (white), 500 mg (Yellow), 750 mg (Orange) and 1000mg (white) tablets for oral administration. The chemical name of levetiracetam, a single ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The precise mechanism(s) by which levetiracetam exerts its antiepileptic effect is unknown. A saturable and stereoselective neuronal binding site in rat brain tissue ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Rats were dosed with levetiracetam in the diet for 104 weeks at doses of 50 mg/kg/day, 300 mg/kg/day and 1,800 ...
  • 14 CLINICAL STUDIES
    14.1 Partial-Onset Seizures - Effectiveness in Partial-Onset Seizures in Adults - The effectiveness of levetiracetam for the treatment of partial-onset seizures in adults was established in three ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Product: 50090-7333 - NDC: 50090-7333-1 60 TABLET, FILM COATED in a BOTTLE - NDC: 50090-7333-2 180 TABLET, FILM COATED in a BOTTLE
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). The Medication Guide accompanies the product and can also be accessed on https://sciegenpharm.com/medication-guide ...
  • MEDICATION GUIDE
    Dispense the Medication Guide available at: https://sciegenpharm.com/medication-guide/ MEDICATION GUIDE - Levetiracetam (LEE-ve-tye-RA-se-tam) tablets, USP for ...
  • Levetiracetam
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  • INGREDIENTS AND APPEARANCE
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