Label: ESCITALOPRAM- escitalopram oxalate tablet, film coated

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

Drug Label Information

Updated June 30, 2022

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for ...
  • 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 oxalate is not approved for use in pediatric patients less than 12 years of age [see Use in Specific Populations (8.4)].

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  • 1 INDICATIONS AND USAGE
    1.1 Major Depressive Disorder - Escitalopram tablets are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see ...
  • 2 DOSAGE AND ADMINISTRATION
    Escitalopram tablets should be administered once daily, in the morning or evening, with or without food. 2.1 Major Depressive Disorder - Initial Treatment -   Adolescents - The recommended ...
  • 3 DOSAGE FORMS AND STRENGTHS
    5 mg are white to off-white, round, biconvex film-coated tablets debossed with ‘F’ on one side and ‘53’ on the other side. 10 mg are white to off-white, oval shaped, biconvex film-coated ...
  • 4 CONTRAINDICATIONS
    4.1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with escitalopram tablets or within 14 days of stopping treatment with escitalopram tablets ...
  • 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
    6.1 Clinical Trials Experience - Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly ...
  • 7 DRUG INTERACTIONS
    7.1 Monoamine Oxidase Inhibitors (MAOIs) [See Dosage and Administration (2.5 and 2.6), Contraindications (4.1) and Warnings and Precautions (5.2)]. 7.2 Serotonergic Drugs - [See Dosage ...
  • 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 oxalate has not been ...
  • 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 tablets contains escitalopram oxalate, an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic ...
  • 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 ...
  • 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 ...
  • 14 CLINICAL STUDIES
    14.1 Major Depressive Disorder - Adolescents - The efficacy of escitalopram oxalate as an acute treatment for major depressive disorder in adolescent patients was established in an 8-week ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Product: 50090-6025 - NDC: 50090-6025-0 1 TABLET, FILM COATED in a BLISTER PACK / 32 in a CARTON
  • 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
    Escitalopram Tablets USP - (es'' sye tal' oh pram) Read the Medication Guide that comes with escitalopram tablets before you start taking them and each time you get a refill. There may be ...
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