Label: ESCITALOPRAM tablet, film coated

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

Drug Label Information

Updated November 8, 2024

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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 ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNINGS: 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 tables are 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 tablets in adults is 10 mg once daily. A fixed-dose trial of escitalopram demonstrated the effectiveness of both ...
  • 3 DOSAGE FORMS AND STRENGTHS
    5 mg: Round, white to off-white, biconvex, film coated tablets, debossed with “P 5” on one side and plain on the other side. 10 mg: Round, white to off-white, biconvex, scored film coated tablets ...
  • 4 CONTRAINDICATIONS
    Escitalopram tablets are contraindicated in patients: taking MAOIs with escitalopram tablets or within 14 days of stopping treatment with escitalopram tablets because of an increased risk of ...
  • 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 Precautions ...
  • 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 - Risk Summary - Based on data form published observational studies, exposure to SSRIs, particulary in the month before delivery, has been associated with a less than 2-fold ...
  • 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 ...
  • 10 OVERDOSAGE
    The following have been reported with escitalopram tablets overdosage: Seizures, which may be delayed, and altered mental status including coma. Cardiovascular toxicity, which may be delayed ...
  • 11 DESCRIPTION
    Escitalopram tablets contains escitalopram a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S-enantiomer (single isomer) of the ...
  • 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 ...
  • 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 Tablets, USP, 5 mgare round, white to off-white, biconvex, film coated tablets, debossed with “P 5” on one side and plain on the other side. They are supplied in ...
  • 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
    Dispense with Medication Guide available at: www.solcohealthcare.com/medguide/escitalopram-tablets-BPL.pdf - Medication Guide - Escitalopram Tablets, USP - (ES-sye-TAL-oh-pram) What is ...
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