Citalopram Tablets USP
10 mg, 20 mg and 40 mg
Rx only

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Citalopram Tablets USP or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Citalopram Tablets USP are not approved for use in pediatric patients.(See Warnings: Clinical Worsening and Suicide Risk,Precautions: Information for Patients, and Precautions: Pediatric Use)

Citalopram is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5- carbonitrile, HBr with the following structural formula:

The molecular formula is C₂₀H₂₂BrFN₂O and its molecular weight is 405.35.

Citalopram hydrobromide occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol.

Citalopram Tablets USP 10 mg, 20 mg and 40 mg contain citalopram hydrobromide in strengths equivalent to 10 mg, 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copolyvidone, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate and titanium dioxide. In addition, Citalopram Tablets USP 10 mg and 20 mg contain red 30 iron oxide.

Citalopram is indicated for the treatment of depression.

The efficacy of citalopram in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY).

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied.

The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated (see WARNINGS).

Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS).

Citalopram Tablets USP are contraindicated in patients with a hypersensitivity to citalopram or any of the inactive ingredients in Citalopram Tablets USP.

The premarketing development program for Citalopram Tablets USP included citalopram exposures in patients and/or normal subjects from 3 different groups of studies: 429 normal subjects in clinical pharmacology/pharmacokinetic studies; 4422 exposures from patients in controlled and uncontrolled clinical trials, corresponding to approximately 1370 patient-exposure years. There were, in addition, over 19,000 exposures from mostly open-label, European postmarketing studies. The conditions and duration of treatment with citalopram varied greatly and included (in overlapping categories) open-label and double-blind studies, inpatient and outpatient studies, fixed-dose and dose-titration studies, and short-term and long-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard World Health Organization (WHO) terminology has been used to classify reported adverse events.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type uled. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Citalopram Tablets USP 10 mg are pink, round, film coated tablets debossed “cor” over “170” on one side and other side is plain.

They are supplied as follows:
NDC 64720-170-03 in bottles of 30's
NDC 64720-170-10 in bottles of 100's

Citalopram Tablets USP 20 mg are pink, round, film coated tablets debossed “cor” above the bisect and “171” below the bisect on one side and other side is plain.

They are supplied as follows:
NDC 64720-171-03 in bottles of 30's
NDC 64720-171-10 in bottles of 100's

Citalopram Tablets USP 40 mg are white, round, film coated tablets debossed “cor” above the bisect and “172” below the bisect on one side and other side is plain.

They are supplied as follows:
NDC 64720-172-03 in bottles of 30's
NDC 64720-172-10 in bottles of 100's

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP/NF.

Keep this and all drugs out of the reach of children.

Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's healthcare provider about:

• all risks and benefits of treatment with antidepressant medicines
• all treatment choices for depression or other serious mental illness