Label: CITALOPRAM tablet

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

Drug Label Information

Updated May 6, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use CITALOPRAM® safely and effectively. See full prescribing information for CITALOPRAM®. Citalopram Tablets, for oral use Initial ...
  • 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)]. Citalopram is not approved for use in pediatric patients[see Use in Specific Populations ( 8.4)].

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  • 1 INDICATIONS AND USAGE
    Citalopram is indicated for the treatment of major depressive disorder (MDD) in adults - [see Clinical Studies ( 14)] .
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosage - Administer Citalopram once daily, with or without food, at an initial dosage of 20 mg once daily, with an increase to a maximum dosage of 40 mg once daily at an interval ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Citalopram tablets are available as: Tablets: 10 mg: Beige film coated, round, biconvex tablets de-bossed with "IG" on one side and "206" on the other.
  • 4 CONTRAINDICATIONS
    Citalopram is contraindicated in patients: taking, or within 14 days of stopping, MAOIs (including MAOIs such as linezolid or intravenous methylene blue) because of an increased risk of serotonin ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Suicidal Thoughts and Behavior 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: Hypersensitivity reactions - [see Contraindications ( 4)] Suicidal thoughts ...
  • 7 DRUG INTERACTIONS
    Table 5 presents clinically important drug interactions with Citalopram. Table 5: Clinically Important Drug Interactions with Citalopram - Monoamine Oxidase Inhibitors (MAOIs) Clinical ...
  • 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
    9.1 Controlled Substance - Citalopram (citalopram HBr) is not a controlled substance. 9.2 Abuse - Animal studies suggest that the abuse liability of Citalopram is low. Citalopram has not been ...
  • 10 OVERDOSAGE
    The following have been reported with Citalopram tablet overdosage: Seizures, which may be delayed, and altered mental status including coma. Cardiovascular toxicity, which may be delayed ...
  • 11 DESCRIPTION
    Citalopram tablet contains citalopram hydrobromide, an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The mechanism of action of citalopram is unclear, but is presumed to be related to potentiation of serotonergic activity in the central nervous system (CNS) resulting ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Citalopram increased the incidence of small intestine carcinoma in rats treated for 24 months at doses of 8 and 24 ...
  • 14 CLINICAL STUDIES
    The efficacy of Citalopram as a treatment for major depressive disorder was established in two placebo-controlled studies (of 4 to 6 weeks duration) in adult outpatients (ages 18-66) meeting ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Citalopram Tablets, USP - 10 mg: They are supplied in - Beige, film coated round, bi-convex tablets debossed with IG on one side and “206” on the other. NDC: 70518-4070-00 - PACKAGING: 30 in 1 BLISTER ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). ' Suicidal Thoughts and Behaviors - Advise patients and caregivers to look for the emergence of suicidality ...
  • SPL UNCLASSIFIED SECTION
    Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
  • MEDICATION GUIDE
    MEDICATION GUIDE - Citalopram Tablets,USP - (sih-TAL-oh-pram) What is the most important information I should know about Citalopram? Citalopram may cause serious side effects ...
  • PRINCIPAL DISPLAY PANEL
    DRUG: Citalopram - GENERIC: Citalopram - DOSAGE: TABLET - ADMINSTRATION: ORAL - NDC: 70518-4070-0 - COLOR: yellow - SHAPE: ROUND - SCORE: No score - SIZE: 6 mm - IMPRINT: 206;IG - PACKAGING: 30 in 1 BLISTER ...
  • INGREDIENTS AND APPEARANCE
    Product Information