Label: LACOSAMIDE solution

  • NDC Code(s): 68462-940-86
  • Packager: Glenmark Pharmaceuticals Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 31, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use LACOSAMIDE ORAL SOLUTION safely and effectively. See full prescribing information for LACOSAMIDE ORAL SOLUTION. LACOSAMIDE oral ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Partial-Onset Seizures - Lacosamide oral solution is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Additional pediatric use information is ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosage Information - The recommended dosage for monotherapy and adjunctive therapy for partial-onset seizures in patients 4 years of age and older and for adjunctive therapy for primary ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Lacosamide Oral Solution, USP - • 10 mg/mL: clear, colorless to yellow or yellow-brown, strawberry-flavored liquid.
  • 4 CONTRAINDICATIONS
    None.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Suicidal Behavior and Ideation - Antiepileptic drugs (AEDs), including lacosamide, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described below and elsewhere in the labeling: • Suicidal Behavior and Ideation [see Warnings and Precautions (5.1)] • Dizziness and Ataxia [see ...
  • 7 DRUG INTERACTIONS
    7.1 Strong CYP3A4 or CYP2C9 Inhibitors - Patients with renal or hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to lacosamide ...
  • 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), such as lacosamide, during ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Lacosamide oral solution contains lacosamide, a Schedule V controlled substance. 9.2 Abuse - Abuse is the intentional, non-therapeutic use of a drug, even once, for ...
  • 10 OVERDOSAGE
    Events reported after an intake of more than 800 mg (twice the maximum recommended daily dosage) of lacosamide include dizziness, nausea, and seizures (generalized tonic-clonic seizures, status ...
  • 11 DESCRIPTION
    The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The precise mechanism by which lacosamide exerts its antiepileptic effects in humans remains to be fully elucidated. In vitro electrophysiological studies have shown ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - There was no evidence of drug related carcinogenicity in mice or rats. Mice and rats received lacosamide once daily ...
  • 14 CLINICAL STUDIES
    14.1 Monotherapy in Patients with Partial-Onset Seizures - The efficacy of lacosamide in monotherapy was established in a historical-control, multicenter, randomized trial that included 425 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - Lacosamide Oral Solution, USP - • 10 mg/mL is a clear, colorless to yellow or yellow-brown, strawberry-flavored liquid. It is supplied as follows:        200 mL in PET ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide). The Medication Guide accompanies the product and can also be accessed on www.glenmarkpharma-us.com or ...
  • Medication Guide
    Lacosamide (la-KOE-sa-mide) Oral Solution, USP, CV - Read this Medication Guide before you start taking lacosamide oral solution and each time you get a refill. There ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Lacosamide Oral Solution, 10 mg/mL (8 Fl. Oz. (200 mL)) Bottle Label
  • INGREDIENTS AND APPEARANCE
    Product Information