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Drug Uses

Celexa is in a class of drugs called selective serotonin reuptake inhibitors. Celexa affects chemicals in the brain that may become unbalanced and cause depression. Celexa is used to treat depression.

How Taken

Celexa comes as a tablet taken by mouth. It is usually taken once daily and may be taken with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Celexa exactly as directed. Do not take more or less of it or take it more often that prescribed by your doctor. Continue to take Celexa even if you feel well. Do not stop taking Celexa without talking to your doctor. This drug must be taken regularly for a few weeks before its full effect is felt.

Warnings/Precautions

Before taking Celexa, tell your doctor if you have liver disease, have kidney disease, suffer from seizures, or suffer from mania or have suicidal thoughts. You may not be able to take Celexa, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Do not take Celexa without first talking to your doctor if you have had an allergic reaction to this medication in the past. Celexa is in the FDA pregnancy category C. This means that it is not known whether Celexa will be harmful to an unborn baby. Do not take Celexa without first talking to your doctor if you are pregnant or could become pregnant during treatment. Celexa passes into breast milk and may affect a nursing infant. Do not take Celexa without first talking to your doctor if you are breast-feeding a baby.

Missed Dose

Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at the same time.

Possible Side Effects

The most common side effect with Celexa is sexual problems in male patients.
Some other possible side effects include:
-nausea
-dry mouth
-sleepiness
-increase in sweating

Storage

Celexa tablets should be stored in a dry place at room temperature between 15° and 30°C

Overdose

Symptoms most often accompanying Celexa overdose, alone or in combination with other drugs and/or alcohol, included dizziness, sweating, nausea, vomiting, tremor, somnolence, and sinus tachycardia. In more rare cases, observed symptoms included amnesia, confusion, coma, convulsions, hyperventilation, cyanosis, rhabdomyolysis, and ECG changes.

More Information

Use caution when driving, operating machinery, or performing other hazardous activities. Celexa may cause dizziness. If you experience dizziness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking Celexa or affect your condition.

Disclaimer

This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.

More on Celexa
(citalopram hydrobromide)
Tablets/Oral Solution

Suicidality and Antidepressant Drugs
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 Celexa 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 be havior. Families and caregivers should be
advised of the need for close observation and communication with the prescriber. Celexa is not
approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk,
PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

DESCRIPTION
Celexa® (citalopram HBr) 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 HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-
fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr.
Citalopram HBr occurs as a fine, white to off-white powder. Citalopram HBr is sparingly soluble in water and
soluble in ethanol.
Celexa (citalopram hydrobromide) is available as tablets or as an oral solution.
Celexa 10 mg tablets are film-coated, oval tablets containing citalopram HBr in strengths equivalent to 10 mg
citalopram base. Celexa 20 mg and 40 mg tablets are film-coated, oval, scored tablets containing citalopram HBr in
strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients:
copolyvidone, corn starch, crosscarmellose sodium, glycerin, lactose monohydrate, magnesium stearate,
hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring
agents in the beige (10 mg) and pink (20 mg) tablets.
Celexa oral solution contains citalopram HBr equivalent to 2 mg/mL citalopram base. It also contains the following
inactive ingredients: sorbitol, purified water, propylene glycol, methylparaben, natural peppermint flavor, and
propylparaben.

Absorption and Distribution
Following a single oral dose (40 mg tablet) of citalopram, peak blood levels occur at about 4 hours. The absolute
bioavailability of citalopram was about 80% relative to an intravenous dose, and absorption is not affected by food.
The volume of distribution of citalopram is about 12 L/kg and the binding of citalopram (CT), demethylcitalopram
(DCT) and didemethylcitalopram (DDCT) to human plasma proteins is about 80%.

Metabolism and Elimination
Following intravenous administrations of citalopram, the fraction of drug recovered in the urine as citalopram and
DCT was about 10% and 5%, respectively. The systemic clearance of citalopram was 330 mL/min, with
approximately 20% of that due to renal clearance.
Citalopram is metabolized to demethylcitalopram (DCT), didemethylcitalopram (DDCT), citalopram-N-oxide, and a
deaminated propionic acid derivative. In humans, unchanged citalopram is the predominant compound in plasma. At
steady state, the concentrations of citalopram's metabolites, DCT and DDCT, in plasma are approximately one-half
and one-tenth, respectively, that of the parent drug. In vitro studies show that citalopram is at least 8 times more
potent than its metabolites in the inhibition of serotonin reuptake, suggesting that the metabolites evaluated do not
likely contribute significantly to the antidepressant actions of citalopram.
In vitro studies using human liver microsomes indicated that CYP3A4 and CYP2C19 are the primary isozymes
involved in the N-demethylation of citalopram.

Population Subgroups
Age - Citalopram pharmacokinetics in subjects ≥ 60 years of age were compared to younger subjects in two normal
volunteer studies. In a single-dose study, citalopram AUC and half-life were increased in the elderly subjects by
30% and 50%, respectively, whereas in a multiple-dose study they were increased by 23% and 30%, respectively. 20
mg is the recommended dose for most elderly patients (see DOSAGE AND ADMINISTRATION).
Gender - In three pharmacokinetic studies (total N=32), citalopram AUC in women was one and a half to two times
that in men. This difference was not observed in five other pharmacokinetic studies (total N=114). In clinical
studies, no differences in steady state serum citalopram levels were seen between men (N=237) and women
(N=388). There were no gender differences in the pharmacokinetics of DCT and DDCT. No adjustment of dosage
on the basis of gender is recommended.
Reduced hepatic function - Citalopram oral clearance was reduced by 37% and half-life was doubled in patients with
reduced hepatic function compared to normal subjects. 20 mg is the recommended dose for most hepatically
impaired patients (see DOSAGE AND ADMINISTRATION).
Reduced renal function - In patients with mild to moderate renal function impairment, oral clearance of citalopram
was reduced by 17% compared to normal subjects. No adjustment of dosage for such patients is recommended. No
information is available about the pharmacokinetics of citalopram in patients with severely reduced renal function
(creatinine clearance < 20 mL/min).

Drug-Drug Interactions
In vitro enzyme inhibition data did not reveal an inhibitory effect of citalopram on CYP3A4, -2C9, or -2E1, but did
suggest that it is a weak inhibitor of CYP1A2, -2D6, and -2C19. Citalopram would be expected to have little
inhibitory effect on in vivo metabolism mediated by these cytochromes. However, in vivo data to address this
question are limited.
Since CYP3A4 and 2C19 are the primary enzymes involved in the metabolism of citalopram, it is expected that
potent inhibitors of 3A4 (e.g., ketoconazole, itraconazole, and macrolide antibiotics) and potent inhibitors of
CYP2C19 (e.g., omeprazole) might decrease the clearance of citalopram. However, coadministration of citalopram
and the potent 3A4 inhibitor ketoconazole did not significantly affect the pharmacokinetics of citalopram. Because
citalopram is metabolized by multiple enzyme systems, inhibition of a single enzyme may not appreciably decrease
citalopram clearance. Citalopram steady state levels were not significantly different in poor metabolizers and
extensive 2D6 metabolizers after multiple-dose administration of Celexa, suggesting that coadministration, with
Celexa, of a drug that inhibits CYP2D6, is unlikely to have clinically significant effects on citalopram metabolism.
See Drug Interactions under PRECAUTIONS for more detailed information on available drug interaction data.

Clinical Efficacy Trials
The efficacy of Celexa as a treatment for depression was established in two placebo-controlled studies (of 4 to 6
weeks in duration) in adult outpatients (ages 18-66) meeting DSM-III or DSM-III-R criteria for major depression.
Study 1, a 6-week trial in which patients received fixed Celexa doses of 10, 20, 40, and 60 mg/day, showed that
Celexa at doses of 40 and 60 mg/day was effective as measured by the Hamilton Depression Rating Scale (HAMD)
total score, the HAMD depressed mood item (Item 1), the Montgomery Asberg Depression Rating Scale, and the
Clinical Global Impression (CGI) Severity scale. This study showed no clear effect of the 10 and 20 mg/day doses,
and the 60 mg/day dose was not more effective than the 40 mg/day dose. In study 2, a 4-week, placebo-controlled
trial in depressed patients, of whom 85% met criteria for melancholia, the initial dose was 20 mg/day, followed by
titration to the maximum tolerated dose or a maximum dose of 80 mg/day. Patients treated with Celexa showed
significantly greater improvement than placebo patients on the HAMD total score, HAMD item 1, and the CGI
Severity score. In three additional placebo-controlled depression trials, the difference in response to treatment
between patients receiving Celexa and patients receiving placebo was not statistically significant, possibly due to
high spontaneous response rate, smaller sample size, or, in the case of one study, too low a dose.
In two long-term studies, depressed patients who had responded to Celexa during an initial 6 or 8 weeks of acute
treatment (fixed doses of 20 or 40 mg/day in one study and flexible doses of 20-60 mg/day in the second study) were
randomized to continuation of Celexa or to placebo. In both studies, patients receiving continued Celexa treatment
experienced significantly lower relapse rates over the subsequent 6 months compared to those receiving placebo. In
the fixed-dose study, the decreased rate of depression relapse was similar in patients receiving 20 or 40 mg/day of
Celexa.
Analyses of the relationship between treatment outcome and age, gender, and race did not suggest any differential
responsiveness on the basis of these patient characteristics.
Comparison of Clinical Trial Results
Highly variable results have been seen in the clinical development of all antidepressant drugs. Furthermore, in those
circumstances when the drugs have not been studied in the same controlled clinical trial(s), comparisons among the
results of studies evaluating the effectiveness of different antidepressant drug products are inherently unreliable.
Because conditions of testing (e.g., patient samples, investigators, doses of the treatments administered and
compared, outcome measures, etc.) vary among trials, it is virtually impossible to distinguish a difference in drug
effect from a difference due to one of the confounding factors just enumerated.

INDICATIONS AND USAGE
Celexa (citalopram HBr) is indicated for the treatment of depression.
The efficacy of Celexa 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
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 Celexa in hospitalized depressed patients has not been adequately studied.
The efficacy of Celexa 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 Celexa for extended periods should periodically re-evaluate the long-term usefulness
of the drug for the individual patient.

CONTRAINDICATIONS
Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated (see WARNINGS).
Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS).
Celexa is contraindicated in patients with a hypersensitivity to citalopram or any of the inactive ingredients in
Celexa.

WARNINGS
Patients 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. Suicide is a known risk of depression and certain other psychiatric
disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-
standing concern, however, that antidepressants may have a role in inducing worsening of depression
and the emergence of suicidality in certain patients during the early phases of treatment.
Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others)
showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children,
adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric
disorders. 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 with antidepressants compared to
placebo in adults aged 65 and older.
The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive
compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9
antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults
with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2
months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of
suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs
studied. There were differences in absolute risk of suicidality across the different indications, with the
highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable
within age strata and across indications. These risk differences (drug-placebo difference in the number
of cases of suicidality per 1000 patients treated) are provided in Table 1.

No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number
was not sufficient to reach any conclusion about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months.
However, there is substantial evidence from placebo-controlled maintenance trials in adults with
depression that the use of antidepressants can delay the recurrence of depression.
All patients being treated with antidepressants for any indication should be monitored
appropriately and 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.
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
Celexa, for a description of the risks of discontinuation of Celexa.
Families and caregivers of 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 Celexa should be written for the smallest
quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Screening Patients for Bipolar Disorder: A major depressive episode may be the initial presentation
of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such
an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic
episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent
such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients
with depressive symptoms should be adequately screened to determine if they are at risk for bipolar
disorder; such screening should include a detailed psychiatric history, including a family history of
suicide, bipolar disorder, and depression. It should be noted that Celexa is not approved for use in
treating bipolar depression.
Potential for Interaction wi th Monoamine Oxidase Inhibitors
In patients receiving serotonin reuptake inhibitor drugs in combination with a monoamine oxidase inhibitor
(MAOI), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity,
myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes
that include extreme agitation progressing to delirium and coma. These reactions have also been reported in
patients who have recently discontinued SSRI treatment and have been started on an MAOI. Some cases
presented with features resembling neuroleptic malignant syndrome. Furthermore, limited animal data on
the effects of combined use of SSRIs and MAOIs suggest that these drugs may act synergistically to elevate
blood pressure and evoke behavioral excitation. Therefore, it is recommended that Celexa should not be used
in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI. Similarly, at
least 14 days should be allowed after stopping Celexa before starting an MAOI.
Serotonin Syndrome:
The development of a potentially life-threatening serotonin syndrome may occur with SNRIs and SSRIs, including
Celexa treatment, particularly with concomitant use of serotonergic drugs (including triptans) and with drugs which
impair metabolism of serotonin (including MAOIs). Serotonin syndrome symptoms may include mental status
changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure,
hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms
(e.g., nausea, vomiting, diarrhea).
The concomitant use of Celexa with MAOIs intended to treat depression is contraindicated (see
CONTRAINDICATIONS and WARNINGS - Potential for Interaction with Monoamine Oxidase Inhibitors.)
If concomitant treatment of Celexa with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted,
careful observation of the patient is advised, particularly during treatment initiation and dose increases (see
PRECAUTIONS - Drug Interactions ).The concomitant use of Celexa with serotonin precursors (such as
tryptophan) is not recommended (see PRECAUTIONS - Drug Interactions ).

PRECAUTIONS
General
Discontinuation of Treatment with Celexa
During marketing of Celexa and other SSRIs and SNRIs (serotonin and norepinephrine reuptake inhibitors), there
have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when
abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g.,
paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia,
and hypomania. While these events are generally self-limiting, there have been reports of serious discontinuation
symptoms.
Patients should be monitored for these symptoms when discontinuing treatment with Celexa. A gradual reduction in
the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a
decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be
considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate (see DOSAGE
AND ADMINISTRATION).
Abnormal Bleeding
Published case reports have documented the occurrence of bleeding episodes in patients treated with psychotropic
drugs that interfere with serotonin reuptake. Subsequent epidemiological studies, both of the case-control and cohort
design, have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake
and the occurrence of upper gastrointestinal bleeding. In two studies, concurrent use of a nonsteroidal anti-
inflammatory drug (NSAID) or aspirin potentiated the risk of bleeding (see Drug Interactions). Although these
studies focused on upper gastrointestinal bleeding, there is reason to believe that bleeding at other sites may be
similarly potentiated. Patients should be cautioned regarding the risk of bleeding associated with the concomitant
use of Celexa with NSAIDs, aspirin, or other drugs that affect coagulation.
Hyponatremia
Cases of hyponatremia and SIADH (syndrome of inappropriate antidiuretic hormone secretion) have been reported
in association with Celexa treatment. All patients with these events have recovered with discontinuation of Celexa
and/or medical intervention. Hyponatremia and SIADH have also been reported in association with other marketed drugs
effective in the treatment of major depressive disorder.
Activation of Mania/Hypomania
In placebo-controlled trials of Celexa, some of which included patients with bipolar disorder, activation of
mania/hypomania was reported in 0.2% of 1063 patients treated with Celexa and in none of the 446 patients treated
with placebo. Activation of mania/hypomania has also been reported in a small proportion of patients with major
affective disorders treated with other marketed antidepressants. As with all antidepressants, Celexa should be used
cautiously in patients with a history of mania.
Seizures
Although anticonvulsant effects of citalopram have been observed in animal studies, Celexa has not been
systematically evaluated in patients with a seizure disorder. These patients were excluded from clinical studies
during the product's premarketing testing. In clinical trials of Celexa, seizures occurred in 0.3% of patients treated
with Celexa (a rate of one patient per 98 years of exposure) and 0.5% of patients treated with placebo (a rate of one
patient per 50 years of exposure). Like other antidepressants, Celexa should be introduced with care in patients with
a history of seizure disorder.
Interference with Cognitive and Motor Performance
In studies in normal volunteers, Celexa in doses of 40 mg/day did not produce impairment of intellectual function or
psychomotor performance. Because any psychoactive drug may impair judgment, thinking, or motor skills,
however, patients should be cautioned about operating hazardous machinery, including automobiles, until they are
reasonably certain that Celexa therapy does not affect their ability to engage in such activities.
Use in Patients with Concomitant Illness
Clinical experience with Celexa in patients with certain concomitant systemic illnesses is limited. Caution is
advisable in using Celexa in patients with diseases or conditions that produce altered metabolism or hemodynamic
responses.
Celexa has not been systematically evaluated in patients with a recent history of myocardial infarction or unstable
heart disease. Patients with these diagnoses were generally excluded from clinical studies during the product's
premarketing testing. However, the electrocardiograms of 1116 patients who received Celexa in clinical trials were
evaluated and the data indicate that Celexa is not associated with the development of clinically significant ECG
abnormalities.
In subjects with hepatic impairment, citalopram clearance was decreased and plasma concentrations were increased.
The use of Celexa in hepatically impaired patients should be approached with caution and a lower maximum dosage
is recommended (see DOSAGE AND ADMINISTRATION).
Because citalopram is extensively metabolized, excretion of unchanged drug in urine is a minor route of elimination.
Until adequate numbers of patients with severe renal impairment have been evaluated during chronic treatment with
Celexa, however, it should be used with caution in such patients (see DOSAGE AND ADMINISTRATION).
Information for Patients
Physicians are advised to discuss the following issues with patients for whom they prescribe Celexa.
Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of Celexa and triptans,
tramadol or other serotonergic agents.
Although in controlled studies Celexa has not been shown to impair psychomotor performance, any psychoactive
drug may impair judgment, thinking, or motor skills, so patients should be cautioned about operating hazardous
machinery, including automobiles, until they are reasonably certain that Celexa therapy does not affect their ability
to engage in such activities.
Patients should be told that, although Celexa has not been shown in experiments with normal subjects to increase the
mental and motor skill impairments caused by alcohol, the concomitant use of Celexa and alcohol in depressed
patients is not advised.
Patients should be advised to inform their physician if they are taking, or plan to take, any prescription or over-the-
counter drugs, as there is a potential for interactions.
Patients should be cautioned about the concomitant use of Celexa and NSAIDs, aspirin, or other drugs that affect
coagulation since the combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has
been associated with an increased risk of bleeding.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during
therapy.
Patients should be advised to notify their physician if they are breastfeeding an infant.
While patients may notice improvement with Celexa therapy in 1 to 4 weeks, they should be advised to continue
therapy as directed.
Prescribers or other health professionals should inform patients, their families, and their caregivers
about the benefits and risks associated with treatment with Celexa and should counsel them in its
appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and
other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for Celexa. The
prescriber or health professional should instruct patients, their families, and their caregivers to read
the Medication Guide and should assist them in understanding its contents. Patients should be given
the opportunity to discuss the contents of the Medication Guide and to obtain answers to any
questions they may have. The complete text of the Medication Guide is reprinted at the end of this
document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur
while taking Celexa.
Clinical Worsening and Suicide Risk: Patients, their families, and their caregivers should be
encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability,
hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other
unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during
antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients
should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may
be abrupt. Such symptoms should be reported to the patient's prescriber or health professional,
especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and
indicate a need for very close monitoring and possibly changes in the medication.

Nursing Mothers
As has been found to occur with many other drugs, citalopram is excreted in human breast milk. There have been
two reports of infants experiencing excessive somnolence, decreased feeding, and weight loss in association with
breastfeeding from a citalopram-treated mother; in one case, the infant was reported to recover completely upon
discontinuation of citalopram by its mother and in the second case, no follow-up information was available. The
decision whether to continue or discontinue either nursing or Celexa therapy should take into account the risks of
citalopram exposure for the infant and the benefits of Celexa treatment for the mother.
Pediatric Use
Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and
WARNINGS—Clinical Worsening and Suicide Risk). Two placebo-controlled trials in 407 pediatric patients
with MDD have been conducted with Celexa, and the data were not sufficient to support a claim for use in pediatric
patients. Anyone considering the use of Celexa in a child or adolescent must balance the potential risks with the
clinical need.
Geriatric Use
Of 4422 patients in clinical studies of Celexa, 1357 were 60 and over, 1034 were 65 and over, and 457 were 75 and
over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects,
and other reported clinical experience has not identified differences in responses between the elderly and younger
patients, but greater sensitivity of some older individuals cannot be ruled out. Most elderly patients treated with
Celexa in clinical trials received daily doses between 20 and 40 mg (see DOSAGE AND ADMINISTRATION).
In two pharmacokinetic studies, citalopram AUC was increased by 23% and 30%, respectively, in elderly subjects as
compared to younger subjects, and its half-life was increased by 30% and 50%, respectively (see CLINICAL
PHARMACOLOGY).
20 mg/day is the recommended dose for most elderly patients (see DOSAGE AND ADMINISTRATION).
ADVERSE REACTIONS
The premarketing development program for Celexa 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 Celexa 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 listed. An event was considered treatment-emergent if it occurred for
the first time or worsened while receiving therapy following baseline evaluation.
Adverse Findings Observed in Short-Term, Placebo-Controlled Trials
Adverse Events Associated with Discontinuation of Treatment
Among 1063 depressed patients who received Celexa at doses ranging from 10 to 80 mg/day in placebo-controlled
trials of up to 6 weeks in duration, 16% discontinued treatment due to an adverse event, as compared to 8% of 446
patients receiving placebo. The adverse events associated with discontinuation and considered drug-related (i.e.,
associated with discontinuation in at least 1% of Celexa -treated patients at a rate at least twice that of placebo) are

OVERDOSAGE
Human Experience
In clinical trials of citalopram, there were reports of citalopram overdose, including overdoses of up to 2000mg, with
no associated fatalities. During the postmarketing evaluation of citalopram, Celexa overdoses, including overdoses
of up to 6000 mg, have been reported. As with other SSRI’s, a fatal outcome in a patient who has taken an overdose
of citalopram has been rarely reported.
Symptoms most often accompanying citalopram overdose, alone or in combination with other drugs and/or alcohol,
included dizziness, sweating, nausea, vomiting, tremor, somnolence, and sinus tachycardia. In more rare cases,
observed symptoms included amnesia, confusion, coma, convulsions, hyperventilation, cyanosis, rhabdomyolysis,
and ECG changes (including QTc prolongation, nodal rhythm, ventricular arrhythmia, and very rare cases of torsade
de pointes). Acute renal failure has been very rarely reported accompanying overdose.
Management of Overdose
Establish and maintain an airway to ensure adequate ventilation and oxygenation. Gastric evacuation by lavage and
use of activated charcoal should be considered. Careful observation and cardiac and vital sign monitoring are
recommended, along with general symptomatic and supportive care. Due to the large volume of distribution of
citalopram, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. There
are no specific antidotes for Celexa.
In managing overdosage, consider the possibility of multiple-drug involvement. The physician should consider
contacting a poison control center for additional information on the treatment of any overdose.

DOSAGE AND ADMINISTRATION
Initial Treatment
Celexa (citalopram HBr) should be administered at an initial dose of 20 mg once daily, generally with an increase to
a dose of 40 mg/day. Dose increases should usually occur in increments of 20 mg at intervals of no less than one
week. Although certain patients may require a dose of 60 mg/day, the only study pertinent to dose response for
effectiveness did not demonstrate an advantage for the 60 mg/day dose over the 40 mg/day dose; doses above 40 mg
are therefore not ordinarily recommended.
Celexa should be administered once daily, in the morning or evening, with or without food.
Special Populations
20 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment, with titration to
40 mg/day only for nonresponding patients.
No dosage adjustment is necessary for patients with mild or moderate renal impairment. Celexa should be used with
caution in patients with severe renal impairment.
Treatment of Pregnant Women During the Third Trimester
Neonates exposed to Celexa and other SSRIs or SNRIs, late in the third trimester, have developed complications
requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating
pregnant women with Celexa during the third trimester, the physician should carefully consider the potential risks
and benefits of treatment. The physician may consider tapering Celexa in the third trimester.
Maintenance Treatment
It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic
therapy. Systematic evaluation of Celexa in two studies has shown that its antidepressant efficacy is maintained for
periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were
assigned randomly to placebo or to the same dose of Celexa (20-60 mg/day) during maintenance treatment as they
had received during the acute stabilization phase, while in the other study, patients were assigned randomly to
continuation of Celexa 20 or 40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates of
relapse to depression were similar for the two dose groups (see Clinical Trials under CLINICAL
PHARMACOLOGY). Based on these limited data, it is not known whether the dose of citalopram needed to
maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a
decrease in dose to 20 mg/day can be considered.
Discontinuation of Treatment with Celexa
Symptoms associated with discontinuation of Celexa and other SSRIs and SNRIs have been reported (see
PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual
reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur
following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose
may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
Switching Patients To or From a Monoamine Oxidase Inhibitor
At least 14 days should elapse between discontinuation of an MAOI and initiation of Celexa therapy. Similarly, at
least 14 days should be allowed after stopping Celexa before starting an MAOI (see CONTRAINDICATIONS and
WARNINGS).
HOW SUPPLIED
Tablets:
10 mg
Bottle of 100
NDC # 0456-4010-01
Beige, oval, film-coated.
Imprint on one side with "FP". Imprint on the other side with "10 mg".
20 mg
Bottle of 100
NDC # 0456-4020-01
10 x 10 Unit Dose
NDC # 0456-4020-63
Pink, oval, scored, film-coated.
Imprint on scored side with "F" on the left side and "P" on the right side.
Imprint on the non-scored side with "20 mg".
40 mg
Bottle of 100
NDC # 0456-4040-01
10 x 10 Unit Dose
NDC # 0456-4040-63
Page 19
19
White, oval, scored, film-coated.
Imprint on scored side with "F" on the left side and "P" on the right side.
Imprint on the non-scored side with "40 mg".
Oral Solution:
10 mg/5 mL, peppermint flavor (240 mL) NDC 0456-4130-08
Store at 25°C (77°F); excursions permitted to 15 - 30°C (59-86°F).

Medication Guide
Antidepressant Medicines, Depression and other Serious Mental Illnesses,
and Suicidal Thoughts or Actions
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
What is the most important information I should know about antidepressant medicines,
depression and other serious mental illnesses, and suicidal thoughts or actions?
1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers,
and young adults within the first few months of treatment.
2. Depression and other serious mental illnesses are the most important causes of suicidal
thoughts and actions. Some people may have a particularly high risk of having suicidal
thoughts or actions. These include people who have (or have a family history of) bipolar illness (also
called manic-depressive illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family
member?
• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or
feelings. This is very important when an antidepressant medicine is started or when the dose is
changed.
• Call the healthcare provider right away to report new or sudden changes in mood, behavior,
thoughts, or feelings.
• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider
between visits as needed, especially if you have concerns about symptoms.
Call a healthcare provider right away if you or your family member has any of the following
symptoms, especially if they are new, worse, or worry you:
• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling very agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking
(mania)
• other unusual changes in behavior or mood
What else do I need to know about antidepressant medicines?
• Never stop an antidepressant medicine without first talking to a healthcare provider.
Stopping an antidepressant medicine suddenly can cause other symptoms.
• Antidepressants are medicines used to treat depression and other illnesses. It is
important to discuss all the risks of treating depression and also the risks of not treating it.
Patients and their families or other caregivers should discuss all treatment choices with
the healthcare provider, not just the use of antidepressants.
• Antidepressant medicines have other side effects. Talk to the healthcare provider about
the side effects of the medicine prescribed for you or your family member.
• Antidepressant medicines can interact with other medicines. Know all of the
medicines that you or your family member takes. Keep a list of all medicines to show the
healthcare provider. Do not start new medicines without first checking with your
healthcare provider.
• Not all antidepressant medicines prescribed for children are FDA approved for use
in children. Talk to your child’s healthcare provider for more information.
This Medication Guide has been approved by the U.S. Food and Drug Administration for all
antidepressants.