CITALOPRAM TABLETS - citalopram hydrobromide tablet, film coated 
International Labs, Inc.





Shellpak(R) Label



Shellpak(R) Label


Citalopram hydrobromide 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, hydrobromide with the
following structural formula:

Picture of Citalopram Chemical Structure

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
Citalopram hydrobromide is available as tablets.
Citalopram 10 mg tablets USP are film-coated, round tablets containing citalopram hydrobromide in strengths equivalent to 10 mg of
citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets USP are film-coated, round, scored tablets containing citalopram
hydrobromide in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: colloidal
silicon dioxide, copovidone, croscarmellose sodium, hypromellose 5 cP, hypromellose 6 cP, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, starch and titanium dioxide. Iron oxides are used as coloring agents in the brown (10 mg) and
pink (20 mg) tablets.



1A 2A 1 2 1 2 1


Absorption and Distribution

Metabolism and Elimination

Population Subgroups




Reduced hepatic function

Reduced renal function

Drug-Drug Interactions

Clinical Efficacy Trials:

Comparison of Clinical Trial Results


Citalopram tablets USP are 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-lII and DSM-llI-R category of major depressive disorder (see CLINICAL PHARMACOLOGY).
A major depressive episode (DSM-lV) 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.




WARNINGS-Clinical Worsening and Suicide Risk
Clinical Worsening and Suicide Risk

Table 1

Picture of Citalopram Table 1

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.


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.

Screening Patients for Bipolar Disorder:

Potential for Interaction with 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 citalopram 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 citalopram before
starting an MAOI.

Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions


Discontinuation of Treatment with Citalopram


Abnormal Bleeding


Activation of Mania/Hypomania


Interference with Cognitive and Motor Performance

Use in Patients with Concomitant Illness



Information for Patients


Clinical Worsening and Suicide Risk:

Laboratory Tests

Drug Interactions

Serotonergic Drugs:

see WARNINGS-Serotonin
citalopram PRECAUTIONS - Drug


WARNINGS - Serotonin Syndrome
CNS Drugs


Monoamine Oxidase Inhibitors (MAOIs) - CONTRAINDICATIONS WARNINGS
Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc











CYP3A4 and 2C19 Inhibitors


Imipramine and Other Tricyclic Antidepressants (TCAs)

Electroconvulsive Therapy (ECT)
Carcinogenesis, Mutagenesis, Impairment of Fertility


Impairment of Fertility

Pregnancy Category C

Pregnancy-Nonteratogenic Effects



Labor and Delivery

Nursing Mothers

Pediatric Use
BOX WARNING and WARNINGS—Clinical Worsening
and Suicide Risk

Geriatric Use


PRECAUTIONS, Hyponatremia



The premarketing development program for citalopram 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 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 citalopram 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 citalopram-treated
patients at a rate at least twice that of placebo) are shown in TABLE 2. It should be noted that one patient can report more than one reason for
discontinuation and be counted more than once in this table.

Picture of Citalopram Table 2

Adverse Events Occurring at an Incidence of 2% or More Among Citalopram-Treated Patients
Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred among 1063
depressed patients who received citalopram at doses ranging from 10 to 80 mg/day in placebo-controlled trials of up to 6 weeks in duration.
Events included are those occurring in 2% or more of patients treated with citalopram and for which the incidence in patients treated with
citalopram was greater than the incidence in placebo-treated patients.
The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical
practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies
cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited
figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to
the adverse event incidence rate in the population studied.
The only commonly observed adverse event that occurred in citalopram patients with an incidence of 5% or greater and at least twice the
incidence in placebo patients was ejaculation disorder (primarily ejaculatory delay) in male patients (see TABLE 3).

Picture of Citalopram Table 3

* Events reported by at least 2% of patients treated with citalopram are reported, except for the following events which had an incidence on
placebo ≥ citalopram: headache, asthenia, dizziness, constipation, palpitation, vision abnormal, sleep disorder, nervousness, pharyngitis,
micturition disorder, back pain.
1 Denominator used was for females only (N=638 citalopram; N=252 placebo).
2 Primarily ejaculatory delay.
3 Denominator used was for males only (N=425 citalopram; N=194 placebo).
Dose Dependency of Adverse Events
The potential relationship between the dose of citalopram administered and the incidence of adverse events was examined in a fixed-dose
study in depressed patients receiving placebo or citalopram 10, 20, 40, and 60 mg. Jonckheere’s trend test revealed a positive dose response
(p less than 0.05) for the following adverse events: fatigue, impotence, insomnia, sweating increased, somnolence, and yawning.
Male and Female Sexual Dysfunction with SSRIs
Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they
may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that SSRIs can cause such untoward sexual
Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult
to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of
untoward sexual experience and performance cited in product labeling, are likely to underestimate their actual incidence.
The table below displays the incidence of sexual side effects reported by at least 2% of patients taking citalopram in a pool of placebocontrolled
clinical trials in patients with depression.

Picture of Citalopram Side Effects Table

In female depressed patients receiving citalopram, the reported incidence of decreased libido and anorgasmia was 1.3% (n=638 females)
and 1.1% (n=252 females), respectively.
There are no adequately designed studies examining sexual dysfunction with citalopram treatment.
Priapism has been reported with all SSRIs.
While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about
such possible side effects

Vital Sign Changes
Citalopram and placebo groups were compared with respect to (1) mean change from baseline in vital signs (pulse, systolic blood pressure,
and diastolic blood pressure) and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in
these variables. These analyses did not reveal any clinically important changes in vital signs associated with citalopram treatment. In addition,
a comparison of supine and standing vital sign measures for citalopram and placebo treatments indicated that citalopram treatment is not
associated with orthostatic changes.
Weight Changes
Patients treated with citalopram in controlled trials experienced a weight loss of about 0.5 kg compared to no change for placebo patients.
Laboratory Changes
Citalopram and placebo groups were compared with respect to (1) mean change from baseline in various serum chemistry, hematology,
and urinalysis variables, and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these
variables. These analyses revealed no clinically important changes in laboratory test parameters associated with citalopram treatment.
ECG Changes
Electrocardiograms from citalopram (N=802) and placebo (N=241) groups were compared with respect to (1) mean change from baseline in
various ECG parameters, and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these
variables. The only statistically significant drug-placebo difference observed was a decrease in heart rate for citalopram of 1.7 bpm compared
to no change in heart rate for placebo. There were no observed differences in QT or other ECG intervals.

Other Events Observed During the Premarketing Evaluation of Citalopram Hydrobromide
Following is a list of WHO terms that reflect treatment-emergent adverse events, as defined in the introduction to the ADVERSE REACTIONS
section, reported by patients treated with citalopram at multiple doses in a range of 10 to 80 mg/day during any phase of a trial within the
premarketing database of 4422 patients. All reported events are included except those already listed in Table 3 or elsewhere in labeling,
those events for which a drug cause was remote, those event terms which were so general as to be uninformative, and those occurring in
only one patient. It is important to emphasize that, although the events reported occurred during treatment with citalopram, they were not
necessarily caused by it.
Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent
adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in less
than 1/100 patients but at least 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.

Cardiovascular - Frequent: tachycardia, postural hypotension, hypotension. Infrequent: hypertension, bradycardia, edema (extremities),
angina pectoris, extrasystoles, cardiac failure, flushing, myocardial infarction, cerebrovascular accident, myocardial ischemia. Rare: transient
ischemic attack, phlebitis, atrial fibrillation, cardiac arrest, bundle branch block.
Central and Peripheral Nervous System Disorders - Frequent: paresthesia, migraine. Infrequent: hyperkinesia, vertigo, hypertonia,
extrapyramidal disorder, leg cramps, involuntary muscle contractions, hypokinesia, neuralgia, dystonia, abnormal gait, hypesthesia, ataxia.
Rare: abnormal coordination, hyperesthesia, ptosis, stupor.
Endocrine Disorders - Rare: hypothyroidism, goiter, gynecomastia.
Gastrointestinal Disorders - Frequent: saliva increased, flatulence. Infrequent: gastritis, gastroenteritis, stomatitis, eructation, hemorrhoids,
dysphagia, teeth grinding, gingivitis, esophagitis. Rare: colitis, gastric ulcer, cholecystitis, cholelithiasis, duodenal ulcer, gastroesophageal
reflux, glossitis, jaundice, diverticulitis, rectal hemorrhage, hiccups.
General - Infrequent: hot flushes, rigors, alcohol intolerance, syncope, influenza-like symptoms. Rare: hayfever.
Hemic and Lymphatic Disorders - Infrequent: purpura, anemia, epistaxis, leukocytosis, leucopenia, lymphadenopathy. Rare: pulmonary
embolism, granulocytopenia, lymphocytosis, lymphopenia, hypochromic anemia, coagulation disorder, gingival bleeding.
Metabolic and Nutritional Disorders - Frequent: decreased weight, increased weight. Infrequent: increased hepatic enzymes, thirst, dry eyes,
increased alkaline phosphatase, abnormal glucose tolerance. Rare: bilirubinemia, hypokalemia, obesity, hypoglycemia, hepatitis, dehydration.
Musculoskeletal System Disorders - Infrequent: arthritis, muscle weakness, skeletal pain. Rare: bursitis, osteoporosis.
Psychiatric Disorders - Frequent: impaired concentration, amnesia, apathy, depression, increased appetite, aggravated depression, suicide
attempt, confusion. Infrequent: increased libido, aggressive reaction, paroniria, drug dependence, depersonalization, hallucination, euphoria,
psychotic depression, delusion, paranoid reaction, emotional lability, panic reaction, psychosis. Rare: catatonic reaction, melancholia.
Reproductive Disorders/Female* - Frequent: amenorrhea. Infrequent: galactorrhea, breast pain, breast enlargement, vaginal hemorrhage.
* % based on female subjects only: 2955

Respiratory System Disorders - Frequent: coughing. Infrequent: bronchitis, dyspnea, pneumonia. Rare: asthma, laryngitis, bronchospasm,
pneumonitis, sputum increased.
Skin and Appendages Disorders - Frequent: rash, pruritus. Infrequent: photosensitivity reaction, urticaria, acne, skin discoloration, eczema,
alopecia, dermatitis, skin dry, psoriasis. Rare: hypertrichosis, decreased sweating, melanosis, keratitis, cellulitis, pruritus ani.
Special Senses - Frequent: accommodation abnormal, taste perversion. Infrequent: tinnitus, conjunctivitis, eye pain. Rare: mydriasis,
photophobia, diplopia, abnormal lacrimation, cataract, taste loss.
Urinary System Disorders - Frequent: polyuria. Infrequent: micturition frequency, urinary incontinence, urinary retention, dysuria. Rare: facial
edema, hematuria, oliguria, pyelonephritis, renal calculus, renal pain.
Other Events Observed During the Postmarketing Evaluation of Citalopram Hydrobromide
It is estimated that over 30 million patients have been treated with citalopram since market introduction. Although no causal relationship to
citalopram treatment has been found, the following adverse events have been reported to be temporally associated with citalopram treatment,
and have not been described elsewhere in labeling: acute renal failure, akathisia, allergic reaction, anaphylaxis, angioedema, choreoathetosis,
chest pain, delirium, dyskinesia, ecchymosis, epidermal necrolysis, erythema multiforme, gastrointestinal hemorrhage, glaucoma, grand mal
convulsions, hemolytic anemia, hepatic necrosis, myoclonus, nystagmus, pancreatitis, priapism, prolactinemia, prothrombin decreased, QT
prolonged, rhabdomyolysis, spontaneous abortion, thrombocytopenia, thrombosis, ventricular arrhythmia, torsade de pointes, and withdrawal


Controlled Substance Class
Citalopram hydrobromide is not a controlled substance.
Physical and Psychological Dependence
Animal studies suggest that the abuse liability of citalopram is low. Citalopram has not been systematically studied in humans for its potential
for abuse, tolerance, or physical dependence. The premarketing clinical experience with citalopram did not reveal any drug-seeking behavior.
However, these observations were not systematic and it is not possible to predict, on the basis of this limited experience, the extent to which
a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate citalopram
patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., development of tolerance,
incrementations of dose, drug-seeking behavior).


Human Experience
In clinical trials of citalopram, there were reports of citalopram overdose, including overdoses of up to 2000 mg, with no associated fatalities.
During the postmarketing evaluation of citalopram, citalopram 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 citalopram.
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.


Initial Treatment
Citalopram 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.
Citalopram 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. Citalopram should be used with caution in patients
with severe renal impairment.

Treatment of Pregnant Women During the Third Trimester
Neonates exposed to citalopram 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 citalopram during the third
trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering citalopram
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 citalopram 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 citalopram
(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 citalopram 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 Citalopram
Symptoms associated with discontinuation of citalopram 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 citalopram therapy. Similarly, at least 14 days should be
allowed after stopping citalopram before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).


Citalopram tablets USP, 10 mg are brown, round, biconvex, film coated tablets embossed “RDY” on one side and “342” on other side. They
are supplied as follows:
NDC 54458-981-10 – in Shellpaks® of 30 tablets.
Citalopram tablets USP, 20 mg are pink, round, biconvex, film coated tablets embossed “RDY” on one side and scored on other side.
They are supplied as follows:
NDC 54458-980-10 – in Shellpaks® of 30 tablets.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Retinal Changes in Rats
Pathologic changes (degeneration/atrophy) were observed in the retinas of albino rats in the 2-year carcinogenicity study with citalopram.
There was an increase in both incidence and severity of retinal pathology in both male and female rats receiving 80 mg/kg/day (13 times the
maximum recommended daily human dose of 60 mg on a mg/m2 basis). Similar findings were not present in rats receiving 24 mg/kg/day for
two years, in mice treated for 18 months at doses up to 240 mg/kg/day, or in dogs treated for one year at doses up to 20 mg/kg/day (4, 20,
and 10 times, respectively, the maximum recommended daily human dose on a mg/m2 basis).

Additional studies to investigate the mechanism for this pathology have not been performed, and the potential significance of this effect in
humans has not been established.
Cardiovascular Changes in Dogs
In a one-year toxicology study, 5 of 10 beagle dogs receiving oral doses of 8 mg/kg/day (4 times the maximum recommended daily human
dose of 60 mg on a mg/m2 basis) died suddenly between weeks 17 and 31 following initiation of treatment. Although appropriate data
from that study are not available to directly compare plasma levels of citalopram (CT) and its metabolites, demethylcitalopram (DCT) and
didemethylcitalopram (DDCT), to levels that have been achieved in humans, pharmacokinetic data indicate that the relative dog-to-human
exposure was greater for the metabolites than for citalopram. Sudden deaths were not observed in rats at doses up to 120 mg/kg/day, which
produced plasma levels of CT, DCT, and DDCT similar to those observed in dogs at doses of 8 mg/kg/day. A subsequent intravenous dosing
study demonstrated that in beagle dogs, DDCT caused QT prolongation, a known risk factor for the observed outcome in dogs. This effect
occurred in dogs at doses producing peak DDCT plasma levels of 810 to 3250 nM (39-155 times the mean steady state DDCT plasma level
measured at the maximum recommended human daily dose of 60 mg). In dogs, peak DDCT plasma concentrations are approximately equal to
peak CT plasma concentrations, whereas in humans, steady state DDCT plasma concentrations are less than 10% of steady state CT plasma
concentrations. Assays of DDCT plasma concentrations in 2020 citalopram-treated individuals demonstrated that DDCT levels rarely exceeded
70 nM; the highest measured level of DDCT in human overdose was 138 nM. While DDCT is ordinarily present in humans at lower levels than
in dogs, it is unknown whether there are individuals who may achieve higher DDCT levels. The possibility that DCT, a principal metabolite
in humans, may prolong the QT interval in dogs has not been directly examined because DCT is rapidly converted to DDCT in that species.

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 particuIarly 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 agressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood
Call your doctor for medical advice about side effects. you may report side
effects to FDA at 1-800-FDA 1088.
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.

Manufactured by:
Dr. Reddy’s Laboratories Limited
Bachepalli – 502 325 INDIA
Packaged by:
International Labs, Inc.
St. Petersburg, FL 33710
Distributed by:
Bentonville, AR 72716

citalopram   tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54458-981 (55111-342)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color brown Score no score
Shape ROUND (Round Bi-convex) Size 6mm
Flavor Imprint Code RDY;342
# NDC Package Description Multilevel Packaging
1 54458-981-10 30 TABLET In 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077038 06/25/2008

citalopram   tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54458-980 (55111-343)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color pink Score 2 pieces
Shape ROUND (Round Bi-convex) Size 8mm
Flavor Imprint Code RDY;343
# NDC Package Description Multilevel Packaging
1 54458-980-10 30 TABLET In 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077038 06/25/2008

Labeler - International Labs, Inc. (023569924)
Registrant - International Labs, Inc. (023569924)
Name Address ID/FEI Operations
International Labs, Inc. 023569924 manufacture, relabel, repack
Name Address ID/FEI Operations
Dr. Reddy's Laboratories Limited 918608162 manufacture
Revised: 11/2009 International Labs, Inc.