Citalopram

Citalopram

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Questions & Answers

Side Effects & Adverse Reactions

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.

Drug-Placebo Difference in Number of Cases of Suicidality

TABLE 1

Age Range

Drug-Placebo Difference in Number of Cases of Suicidality
 per 1000 Patients Treated

Increases

Compared to Placebo

<18

14 additional cases

18-24

5 additional cases

Decreases

Compared to Placebo

25-64

1 fewer case

≥65

6 fewer cases

Cases of Suicidality per 1000 Patients Treated

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 Citalopram Tablets, for a description of the risks of discontinuation of citalopram tablets).

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

 

Citalopram causes dose-dependent QTc prolongation, an ECG abnormality that has been associated with Torsade de Pointes (TdP), ventricular tachycardia, and sudden death, all of which have been observed in postmarketing reports for citalopram.

Individually corrected QTc (QTcNi) interval was evaluated in a randomized, placebo and active (moxifloxacin 400 mg) controlled cross-over, escalating multiple-dose study in 119 healthy subjects. The maximum mean (upper bound of the 95% one-sided confidence interval) difference from placebo were 8.5 (10.8) and 18.5 (21.0) msec for 20 mg and 60 mg citalopram, respectively. Based on the established exposure-response relationship, the predicted QTcNi change from placebo (upper bound of the 95% one-sided confidence interval) under the Cmax for the dose of 40 mg is 12.6 (14.3) msec.

Because of the risk of QTc prolongation at higher citalopram doses, it is recommended that citalopram should not be given at doses above 40 mg/day.

It is recommended that citalopram should not be used in patients with congenital long QT syndrome, bradycardia, hypokalemia or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure. Citalopram should also not be used in patients who are taking other drugs that prolong the QTc interval. Such drugs include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin), or any other class of medications known to prolong the QTc interval (e.g., pentamidine, levomethadyl acetate, methadone).

The citalopram dose should be limited in certain populations. The maximum dose should be limited to 20 mg/day in patients who are CYP2C19 poor metabolizers or those patients who may be taking concomitant cimetidine or another CYP2C19 inhibitor, since higher citalopram exposures would be expected. The maximum dose should also be limited to 20 mg/day in patients with hepatic impairment and in patients who are greater than 60 years of age because of expected higher exposures.

Electrolyte and/or ECG monitoring is recommended in certain circumstances. Patients being considered for citalopram treatment who are at risk for significant electrolyte disturbances should have baseline serum potassium and magnesium measurements with periodic monitoring. Hypokalemia (and/or hypomagnesemia) may increase the risk of QTc prolongation and arrhythmia, and should be corrected prior to initiation of treatment and periodically monitored. ECG monitoring is recommended in patients for whom citalopram use is not recommended (see above), but, nevertheless, considered essential. These include those patients with the cardiac conditions noted above, and those taking other drugs that may prolong the QTc interval.

Citalopram should be discontinued in patients who are found to have persistent QTc measurements >500 ms. If patients taking citalopram experience symptoms that could indicate the occurrence of cardiac arrhythmias, e.g., dizziness, palpitations, or syncope, the prescriber should initiate further evaluation, including cardiac monitoring.

 

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 citalopram tablets are not approved for use in treating bipolar depression.

 

The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including citalopram tablets, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.

The concomitant use of citalopram tablets with MAOIs intended to treat psychiatric disorders is contraindicated. Citalopram tablets should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking citalopram tablets. Citalopram tablets should be discontinued before initiating treatment with the MAOI (see CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION).

If concomitant use of citalopram with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan and St. John’s Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome particularly during treatment initiation and dose increases.

Treatment with citalopram and any concomitant serotonergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.

 

The pupillary dilation that occurs following use of many antidepressant drugs including citalopram may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

 

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Citalopram Tablets USP are indicated for the treatment of depression.

The efficacy of citalopram tablets 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 tablets in hospitalized depressed patients has not been adequately studied.

The efficacy of citalopram tablets 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 tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

 

History

There is currently no drug history available for this drug.

Other Information

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:

MM1

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 hydrobromide is available only in tablet dosage form.

Citalopram Tablets USP, 10 mg are modified oval-shaped, white, film-coated tablets, in strengths equivalent to 10 mg citalopram base.

Citalopram Tablets USP, 20 mg are modified oval-shaped, white, film-coated tablets, in strengths equivalent to 20 mg of citalopram base.

Citalopram Tablets USP, 40 mg are capsule-shaped, white, film-coated tablets in strengths equivalent to 40 mg of citalopram base.

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80 and titanium dioxide.

 

Citalopram Manufacturers


  • Remedyrepack Inc.
    Citalopram Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Citalopram (Citalopram Hydrobromide) Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Citalopram Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Citalopram Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Citalopram Tablet, Film Coated [Remedyrepack Inc. ]
  • Blenheim Pharmacal, Inc.
    Citalopram Tablet [Blenheim Pharmacal, Inc.]
  • State Of Florida Doh Central Pharmacy
    Citalopram Tablet [State Of Florida Doh Central Pharmacy]
  • Remedyrepack Inc.
    Citalopram Tablet [Remedyrepack Inc. ]
  • Preferred Pharmaceuticals, Inc.
    Citalopram Tablet [Preferred Pharmaceuticals, Inc.]
  • Cobalt Laboratories
    Citalopram (Citalopram Hydrobromide) Tablet, Film Coated [Cobalt Laboratories]
  • Rebel Distributors Corp.
    Citalopram (Citalopram Hydrobromide) Tablet, Film Coated [Rebel Distributors Corp.]
  • Contract Pharmacy Services-pa
    Citalopram (Citalopram Hydrobromide) Tablet, Film Coated [Contract Pharmacy Services-pa]
  • Contract Pharmacy Services-pa
    Citalopram Tablet [Contract Pharmacy Services-pa]
  • State Of Florida Doh Central Pharmacy
    Citalopram (Citalopram Hydrobromide) Tablet, Film Coated [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Citalopram Tablet, Film Coated [State Of Florida Doh Central Pharmacy]
  • Legacy Pharmaceutical Packaging
    Citalopram (Citalopram Hydrobromide) Tablet [Legacy Pharmaceutical Packaging]
  • Blenheim Pharmacal, Inc.
    Citalopram Tablet [Blenheim Pharmacal, Inc.]
  • Blenheim Pharmacal, Inc.
    Citalopram Tablet [Blenheim Pharmacal, Inc.]
  • Physicians Total Care, Inc.
    Citalopram (Citalopram Hydrobromide) Tablet, Film Coated [Physicians Total Care, Inc.]
  • Redpharm Drug Inc.
    Citalopram (Citalopram Hydrobromide) Tablet, Film Coated [Redpharm Drug Inc.]
  • Mckesson Contract Packaging
    Citalopram Tablet [Mckesson Contract Packaging]
  • H.j. Harkins Company, Inc.
    Citalopram (Citalopram) Tablet [H.j. Harkins Company, Inc.]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Citalopram Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Citalopram Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Golden State Medical Supply, Inc.
    Citalopram Tablet [Golden State Medical Supply, Inc.]
  • Rebel Distributors Corp
    Citalopram Tablet [Rebel Distributors Corp]
  • Aurolife Pharma Llc
    Citalopram Tablet [Aurolife Pharma Llc]
  • Medvantx, Inc.
    Citalopram Tablet [Medvantx, Inc.]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Citalopram Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Pd-rx Pharmaceuticals, Inc.
    Citalopram Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Citalopram Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Unit Dose Services
    Citalopram Tablet [Unit Dose Services]
  • Remedyrepack Inc.
    Citalopram Tablet [Remedyrepack Inc. ]
  • Camber Pharmaceuticals
    Citalopram Tablet [Camber Pharmaceuticals]
  • Remedyrepack Inc.
    Citalopram Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Citalopram Tablet [Remedyrepack Inc. ]
  • Apotex Corp.
    Citalopram (Citalopram ) Tablet, Film Coated Citalopram (Citalopram Hydrobromide) Tablet, Film Coated [Apotex Corp.]
  • Medvantx, Inc.
    Citalopram Tablet [Medvantx, Inc.]
  • Aphena Pharma Solutions – New Jersey, Llc
    Citalopram Tablet [Aphena Pharma Solutions – New Jersey, Llc]
  • Remedyrepack Inc.
    Citalopram Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Citalopram Tablet [Remedyrepack Inc. ]
  • Clinical Solutions Wholesale
    Citalopram Tablet [Clinical Solutions Wholesale]
  • American Health Packaging
    Citalopram Tablet [American Health Packaging]
  • Medvantx, Inc.
    Citalopram Tablet [Medvantx, Inc.]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Citalopram Tablet [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Citalopram Tablet [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Lake Erie Medical Dba Quality Care Products Llc
    Citalopram Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Legacy Pharmaceutical Packaging
    Citalopram Tablet [Legacy Pharmaceutical Packaging]
  • Preferred Pharmaceuticals, Inc
    Citalopram Tablet [Preferred Pharmaceuticals, Inc]
  • International Labs, Inc.
    Citalopram Tablet [International Labs, Inc.]
  • Clinical Solutions Wholesale
    Citalopram Tablet [Clinical Solutions Wholesale]
  • Blu Pharmaceuticals, Llc
    Citalopram Tablet [Blu Pharmaceuticals, Llc]
  • Remedyrepack Inc.
    Citalopram Tablet [Remedyrepack Inc. ]
  • New Horizon Rx Group, Llc
    Citalopram Tablet [New Horizon Rx Group, Llc]
  • Blenheim Pharmacal, Inc.
    Citalopram Tablet, Film Coated [Blenheim Pharmacal, Inc.]
  • Mylan Pharmaceuticals Inc.
    Citalopram Tablet, Film Coated [Mylan Pharmaceuticals Inc.]
  • American Health Packaging
    Citalopram (Citalopram Hydrobromide) Tablet, Film Coated [American Health Packaging]
  • Teva Pharmaceuticals Usa Inc
    Citalopram Tablet [Teva Pharmaceuticals Usa Inc]
  • Direct Rx
    Citalopram Tablet [Direct Rx]
  • Cardinal Health
    Citalopram Tablet [Cardinal Health]
  • State Of Florida Doh Central Pharmacy
    Citalopram Tablet [State Of Florida Doh Central Pharmacy]
  • Readymeds
    Citalopram Tablet [Readymeds]
  • International Labs, Inc.
    Citalopram Tablet, Film Coated [International Labs, Inc.]
  • St Marys Medical Park Pharmacy
    Citalopram Tablet [St Marys Medical Park Pharmacy]
  • Epic Pharma, Llc
    Citalopram Tablet, Film Coated [Epic Pharma, Llc]
  • Remedyrepack Inc.
    Citalopram (Citalopram Hydrobromide) Tablet, Film Coated [Remedyrepack Inc. ]
  • Eon Labs, Inc.
    Citalopram (Citalopram Hydrobromide) Tablet, Film Coated [Eon Labs, Inc.]
  • Aurobindo Pharma Limited
    Citalopram (Citalopram Hydrobromide) Tablet, Film Coated [Aurobindo Pharma Limited]
  • Proficient Rx Lp
    Citalopram (Citalopram Hydrobromide) Tablet, Film Coated [Proficient Rx Lp]
  • Amneal Pharmaceuticals Of New York, Llc
    Citalopram Tablet [Amneal Pharmaceuticals Of New York, Llc]
  • Amneal Pharmaceuticals Of New York, Llc
    Citalopram Tablet [Amneal Pharmaceuticals Of New York, Llc]
  • Cardinal Health
    Citalopram Tablet, Film Coated [Cardinal Health]
  • State Of Florida Doh Central Pharmacy
    Citalopram Tablet, Film Coated [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Citalopram (Citalopram Hydrobromide) Tablet, Film Coated [State Of Florida Doh Central Pharmacy]
  • Safecor Health, Llc
    Citalopram (Citalopram Hydrobromide) Tablet, Film Coated [Safecor Health, Llc]
  • Clinical Solutions Wholesale, Llc
    Citalopram Tablet [Clinical Solutions Wholesale, Llc]
  • Remedyrepack Inc.
    Citalopram Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Citalopram Tablet, Film Coated [Remedyrepack Inc. ]

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