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Basic Drug Info
Drug Name:Citalopram Hydrobromide
Manufacturer:Roxane Laboratories, Inc.I
Other Info:

No.

This is a warning about the risk for suicidality.

Other side effects can occur with antidepressants.

Be sure to ask your healthcare provider to explain all the side effects of the particular drug he or she is prescribing.

Also ask about drugs to avoid when taking an antidepressant.

Ask your healthcare provider or pharmacist where to find more information.*Prozac® is a registered trademark of Eli Lilly and Company*Zoloft® is a registered trademark of Pfizer Pharmaceuticals*Anafranil® is a registered trademark of Mallinckrodt Inc.This Medication Guide has been approved by the U.S.

Food and Drug Administration for all antidepressants.10003824/01© RLI, 2005



Clinical Trials:


Indications and Usage

Citalopram Hydrobromide Oral Solution is indicated for the treatment of depression.The efficacy of Citalopram Hydrobromide Oral Solution in the treatment of depression was established in 4 to 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 Hydrobromide Oral Solution in hospitalized depressed patients has not been adequately studied.The efficacy of Citalopram Hydrobromide Oral Solution 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 Hydrobromide Oral Solution for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Sleeplessness -- Difficulty in going to sleep or getting enough sleep.

Hypersomnia --

Agitation -- A feeling of restlessness associated with increased motor activity. This may occur as a manifestation of nervous system drug toxicity or other conditions.

Fatigue -- The state of weariness following a period of exertion, mental or physical, characterized by a decreased capacity for work and reduced efficiency to respond to stimuli.

Contraindications
Concomitant use in patients taking monoamine oxidase inhibitors (MAOI’s) is contraindicated (see WARNINGS).Citalopram Hydrobromide Oral Solution is contraindicated in patients with a hypersensitivity to citalopram or any of the inactive ingredients in Citalopram Hydrobromide Oral Solution.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Clinical Worsening and Suicide RiskPatients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs.

There has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients.

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.

Pooled analyses of short-term placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with MDD, OCD, or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal behavior or thinking (suicidality) during the first few months of treatment in those receiving antidepressants.

The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%.

There was considerable variation in risk among drugs, but a tendency toward an increase for almost all drugs studied.

The risk of suicidality was most consistently observed in the MDD trials, but there were signals of risk arising from some trials in other psychiatric indications (obsessive compulsive disorder and social anxiety disorder) as well.

No suicides occurred in any of these trials.

It is unknown whether the suicidality risk in pediatric patients extends to longer-term use, i.e., beyond several months.

It is also unknown whether the suicidality risk extends to adults.

All pediatric patients being treated with antidepressants for any indication should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

Such observation would generally include at least weekly face-to-face contact with patients or their family members or caregivers during the first 4 weeks of treatment, then every other week visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks.

Additional contact by telephone may be appropriate between face-to-face visits.

Adults with MDD or co-morbid depression in the setting of other psychiatric illness being treated with antidepressants should be observed similarly for clinical worsening and suicidality, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.

Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms (see PRECAUTIONS and DOSAGE AND ADMINISTRATION-Discontinuation of Treatment with Citalopram, for a description of the risks of discontinuation of Citalopram Hydrobromide).

Families and caregivers of pediatric patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers.

Such monitoring should include daily observation by families and caregivers.

Prescriptions for Citalopram Hydrobromide should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Families and caregivers of adults being treated for depression should be similarly advised.
Branded Drugs
The following US Branded drugs contain Citalopram Hydrobromide


CELEXA -- FOREST LABORATORIES INC


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