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Citalopram Hydrobromide

FDA Drug Information • Also known as: Citalopram, Citalopram Hydrobromide

Brand Names
Citalopram, Citalopram Hydrobromide
Dosage Form
TABLET, FILM COATED
Product Type
DRUG FOR FURTHER PROCESSING

⚠ Boxed Warning (Black Box)

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 tablets are not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning .

  • Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughs and behaviors ( 5.1 ) .
  • Citalopram tablets are not approved for use in pediatric patients ( 8.4 ) .

    • Description

    11 DESCRIPTION Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3‑dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula: The molecular formula is C 20 H 22 BrFN 2 O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch, and titanium dioxide. image description

    What Is Citalopram Hydrobromide Used For?

    1 INDICATIONS AND USAGE Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )] . Citalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ) .

    Dosage and Administration

    2 DOSAGE AND ADMINISTRATION

  • Administer once daily with or without food ( 2 ) .
  • Initial dosage is 20 mg once daily; after one week may increase to maximum dosage of 40 mg once daily ( 2.1 ) .
  • Patients greater than 60 years of age, patients with hepatic impairment, and CYP2C19 poor metabolizers: maximum recommended dosage is 20 mg once daily ( 2.2 ) .
  • When discontinuing citalopram tablets, reduce dosage gradually ( 2.4 , 5.6 ) .

    • Side Effects (Adverse Reactions)

    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 and behaviors in adolescents and young adults [see Warnings and Precautions ( 5.1 )]
  • QT-prolongation and torsade de pointes [see Warnings and Precautions ( 5.2 )]
  • Serotonin syndrome [see Warnings and Precautions ( 5.3 )]
  • Increased risk of bleeding [see Warnings and Precautions ( 5.4 )]
  • Activation of mania or hypomania [see Warnings and Precautions ( 5.5 )]
  • Discontinuation syndrome [see Warnings and Precautions ( 5.6 )]
  • Seizures [see Warnings and Precautions ( 5.7 )]
  • Angle-closure glaucoma [see Warnings and Precautions ( 5.8 )]
  • Hyponatremia [see Warnings and Precautions ( 5.9 )]
  • Sexual Dysfunction [see Warnings and Precautions ( 5.10 )] Most common adverse reaction (incidence ≥ 5% and twice placebo) is ejaculation disorder (primarily ejaculation delay) ( 6.1 ) . To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc . at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    • Drug Interactions

    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 Impact Concomitant use of SSRIs, including citalopram, and MAOIs increases the risk of serotonin syndrome. Intervention Citalopram is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration ( 2.5 ), Contraindications ( 4 ), Warnings and Precautions ( 5.3 )] . Pimozide Clinical Impact: Concomitant use of citalopram with pimozide increases plasma concentrations of pimozide, a drug with a narrow therapeutic index, and may increase the risk of QT prolongation and/or ventricular arrhythmias compared to use of citalopram alone [see Clinical Pharmacology ( 12.2 )]. Intervention: Citalopram is contraindicated in patients taking pimozide [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )]. Drugs that Prolong the QTc Interval Clinical Impact: Concomitant use of citalopram with drugs that prolong QT can cause additional QT prolongation compared to the use of citalopram alone [see Clinical Pharmacology ( 12.2 )]. Intervention: Avoid concomitant use of citalopram with drugs that prolong the QT interval (citalopram is contraindicated in patients taking pimozide) [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )]. CYP2C19 Inhibitors Clinical Impact: Concomitant use of citalopram with CYP2C19 inhibitors increases the risk of QT prolongation and/or ventricular arrhythmias compared to the use of citalopram alone [see Clinical Pharmacology ( 12.2 )]. Intervention: The maximum recommended dosage of citalopram is 20 mg daily when used concomitantly with a CYP2C19 inhibitor [see Dosage and Administration ( 2.4 ), Warnings and Precautions ( 5.2 )]. Serotonergic Drugs Clinical Impact: Concomitant use of citalopram and other serotonergic drugs increases the risk of serotonin syndrome. Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during citalopram initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of citalopram and/or concomitant serotonergic drugs [see Warning and Precautions ( 5.3 )]. Drugs That Interfere With Hemostasis (antiplatelet agents and anticoagulants) Clinical Impact: Concomitant use of citalopram and an antiplatelet or anticoagulant may potentiate the risk of bleeding. Intervention: Inform patients of the increased risk of bleeding associated with the concomitant use of citalopram and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [see Warning and Precautions ( 5.4 )]. CYP2C19 Inhibitors : Citalopram tablets 20 mg daily is the maximum recommended dosage for patients taking concomitant CYP2C19 inhibitors ( 5.2 , 7 ) .

    Contraindications

    4 CONTRAINDICATIONS Citalopram tablets are 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 syndrome [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )] .
  • taking pimozide because of risk of QT prolongation [see Drug Interactions ( 7 )] .
  • with known hypersensitivity to citalopram or any of the inactive ingredients in citalopram tablets. Reactions have included angioedema and anaphylaxis [see Adverse Reactions ( 6.2 )] .
  • Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of discontinuing a MAOI ( 4 ) .
  • Concomiant use of pimozide ( 4 ) .
  • Known hypersensitivity to citalopram or any of the inactive ingredients of citalopram tablets ( 4 ) .

    • Overdosage

    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, including QRS and QTc interval prolongation, wide complex tachyarrhythmias, and torsade de pointes. Hypertension most commonly seen, but rarely can see hypotension alone or with co‐ingestants including alcohol.
  • Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk). Prolonged cardiac monitoring is recommended in citalopram overdosage ingestions due to the arrhythmia risk. Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a citalopram overdose. Consider contacting a Poison Center (1‐800‐221‐2222) or a medical toxicologist for additional overdosage management recommendations.

    • How Supplied

    16 HOW SUPPLIED/STORAGE AND HANDLING Citalopram Tablets, USP contain citalopram hydrobromide USP, equivalent to 40 mg citalopram base. Citalopram Tablets, USP 40 mg Bottle of 30 NDC 71205-764-30 Bottle of 60 NDC 71205-764-60 Bottle of 90 NDC 71205-764-90 Tan coloured, oval shaped, biconvex film coated tablets with ‘4│0’ debossed (‘4’ on left side and ‘0’ on right side of the break line) on one side and ‘1011’ on the other side. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.