Label: ESCITALOPRAM ORAL SOLUTION- escitalopram oral solution

  • NDC Code(s): 62135-729-10, 62135-729-24, 62135-729-37
  • Packager: Chartwell RX, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 5, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    Escitalopram OS - These highlights do not include all the information needed to use ESCITALOPRAM ORAL SOLUTION safely and effectively. See full prescribing information for ESCITALOPRAM ORAL ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

    Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [ see Warnings and Precautions (5.1)]. Escitalopram is not approved for use in pediatric patients less than 7 years of age [ see Use in Specific Populations (8.4)] .

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  • 1 INDICATIONS AND USAGE
    Escitalopram is indicated for the treatment of: major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. generalized anxiety disorder (GAD) in ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Major Depressive Disorder - Adults - The recommended dosage of escitalopram in adults is 10 mg once daily. A fixed-dose trial of escitalopram demonstrated the effectiveness of both 10 mg and ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Oral Solution - Escitalopram Oral Solution, USP contains escitalopram oxalate equivalent to 1 mg/mL escitalopram base.
  • 4 CONTRAINDICATIONS
    Escitalopram is contraindicated in patients: taking MAOIs with escitalopram or within 14 days of stopping treatment with escitalopram because of an increased risk of serotonin syndrome. The use ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Suicidal Thoughts and Behaviors in Adolescents and Young Adults - In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal thoughts and behaviors in adolescents and young adults [ see - Warnings and ...
  • 7 DRUG INTERACTIONS
    Table 6 presents clinically important drug interactions with escitalopram. TABLE 6 Clinically Important Drug Interactions with Escitalopram - Monoamine Oxidase Inhibitors ...
  • 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 antidepressants during pregnancy. Healthcare providers ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.2 Abuse and Dependence - Physical and Psychological Dependence - Animal studies suggest that the abuse liability of racemic citalopram is low. Escitalopram has not been systematically studied in ...
  • 10 OVERDOSAGE
    The following have been reported with escitalopram tablet overdosage: Seizures, which may be delayed, and altered mental status including coma. Cardiovascular toxicity, which may be delayed ...
  • 11 DESCRIPTION
    Escitalopram Oral Solution, USP contains escitalopram oxalate, an orally administered selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The mechanism of antidepressant action of escitalopram, the S-enantiomer of racemic citalopram, is presumed to be linked to potentiation of serotonergic activity in the ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Racemic citalopram was administered in the diet to NMRI/BOM strain mice and COBS WI strain rats for 18 and 24 months ...
  • 14 CLINICAL STUDIES
    14.1 Major Depressive Disorder - Adults - The efficacy of escitalopram as a treatment for major depressive disorder was established in three, 8-week, placebo-controlled studies conducted in ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    How Supplied - Escitalopram Oral Solution, USP,5 mg/5 mL, a clear, colorless liquid with peppermint flavor - 240 mL bottle (8 fluid oz)           NDC# 62135-729-37 - Unit Dose Cup of 10 ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors - Advise patients, their families and caregivers to look for the emergence of ...
  • MEDICATION GUIDE
    Print Medication Guides at: www.chartwellpharma.com/medguides - Medication Guide - Escitalopram (es” sye tal’ oh pram) Oral Solution, USP - What is the most important information I ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Escitalopram Oral Solution, USP - 5 mg per 5 mL - NDC 62135-729-37 - 240 mL - Bottle Label - Escitalopram Oral Solution, USP - 10 mg per 10 mL - NDC 62135-729-10 - 10 mL - Cup Label
  • INGREDIENTS AND APPEARANCE
    Product Information