Citalopram Hydrobromide (2 brand names, 4 dosage forms, 2 routes)
Available dosage forms: SOLUTION, TABLET, CAPSULE, TABLET, ORALLY DISINTEGRATING.
Routes of administration: ORAL, ORALLY DISINTEGRATING.
Brand Names
- CELEXA
- CITALOPRAM HYDROBROMIDE
Boxed Warning
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)] .
Indications and Usage
Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .
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)] .
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)]
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)]. Other Serotonergic Drugs Clinical Impact: Concomitant use of citalopram and other serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithiu
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.