CELEXA (citalopram hydrobromide)

The single- and multiple-dose pharmacokinetics of citalopram are linear and dose-proportional in a dose range of 10 to 40 mg/day. Biotransformation of citalopram is mainly hepatic, with a mean terminal half-life of about 35 hours. With once daily dosing, steady state plasma concentrations are achieved within approximately one week. At steady state, the extent of accumulation of citalopram in plasma, based on the half-life, is expected to be 2.5 times the plasma concentrations observed after a si...

The efficacy of CELEXA 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 DSM-III or DSM-III-R criteria for major depressive disorder (MDD) (Studies 1 and 2). Study 1, a 6-week trial in which patients received fixed CELEXA doses of 10 mg, 20 mg, 40 mg, and 60 mg daily, showed that CELEXA 40 daily and 60 mg daily (1.5 times the maximum recommended daily dosage) was effective as measured by the Hamilton Depression Rating Scale (HAMD) total score, the primary efficacy endpoint. The HAM...

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 W...

CELEXA 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 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 ...

QT-Prolongation and Torsade de Pointes : Dose-dependent QTc prolongation, Torsade de pointes, ventricular tachycardia, and sudden death have occurred. Avoid use of CELEXA in patients with congenital long QT syndrome, bradycardia, hypokalemia or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure and patients taking other drugs that prolong the QTc interval. Monitor electrolytes in patients at high risk for hypokalemia or hypomagnesemia. Discontinue CELEXA in patien...

7 DRUG INTERACTIONS Table 5 presents clinically important drug interactions with CELEXA.

Table 5Clinically Important Drug Interactions with CELEXA Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of SSRIs, including CELEXA, and MAOIs increases the risk of serotonin syndrome. Intervention CELEXA is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or ...