Prescription Drug Information: Citalopram

CITALOPRAM- citalopram hydrobromide capsule
Almatica Pharma LLC

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WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. Citalopram Capsules is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].

1 INDICATIONS AND USAGE

Citalopram Capsules are indicated for the treatment of Major Depressive Disorder (MDD) in adults [see Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Do not initiate treatment with Citalopram Capsules because the only available dose strength is 30 mg. Use another citalopram product for initial dosage, titration, and dosages other than 30 mg once daily. Refer to Prescribing Information of the other citalopram products for the recommended dosage for those products.

Administer Citalopram Capsules orally, once daily, with or without food.

Citalopram should be administered at an initial dose of 20 mg once daily, with an increase to a maximum dose of 40 mg once daily at an interval of no less than one week. Citalopram dosages above 40 mg once daily are not recommended due to the risk of QT prolongation [see Warnings and Precautions (5.2)].

2.2 Screen for Bipolar Disorder Prior to Starting Citalopram Capsules

Prior to initiating treatment with Citalopram Capsules or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.5)].

2.3 Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepresssant

At least 14 days must elapse between discontinuation of an monoamine oxidase inhibitor (MAOI) and initiation of therapy with Citalopram Capsules. Conversely, at least 14 days must elapse after stopping Citalopram Capsules before starting an MAOI antidepressant [see Contraindications (4), Warnings and Precautions (5.3)].

2.4 Discontinuing Treatment with Citalopram Capsules

Adverse reactions may occur upon discontinuation of Citalopram Capsules [see Warnings and Precautions (5.6)]. Gradually reduce the dosage rather than stopping Citalopram Capsules abruptly whenever possible. Given that 30 mg is only available dosage strength of Citalopram Capsules, gradual dosage reduction will require the use of another citalopram product.

3 DOSAGE FORMS AND STRENGTHS

30 mg: Hard shell gelatin capsules, with “ALM” printed axially on the blue opaque cap in black ink and “691” printed axially on the white opaque body in black ink.

Citalopram Capsules dosage strength is based on the active moiety, citalopram.

4 CONTRAINDICATIONS

Citalopram Capsules is contraindicated in patients:

  • taking, or within 14 days of stopping, MAOIs (including MAOIs such as linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.3), Drug Interactions (7)].
  • taking pimozide because of risk of QT prolongation [see Drug Interactions (7)].
  • with known hypersensitivity to citalopram or any of the inactive ingredients in Citalopram Capsules. Reactions have included angioedema and anaphylaxis [see Adverse Reactions (6.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Suicidal Thoughts and Behaviors in Adolescent and Young Adults

In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. These drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1.

Table 1: Risk Differences of the Number of Patients with Suicidal Thoughts or Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric* and Adult Patients
*Citalopram Capsules is not approved for use in pediatric patients.
Age Range Drug-Placebo Difference in Number of Patients* with Suicidal Thoughts or Behaviors per 1,000 Patients Treated
Increases Compared to Placebo
<18 years old 14 additional cases
18 to 24 years old 5 additional cases
Decreases Compared to Placebo
25 to 64 years old 1 fewer case
≥65 years old 6 fewer cases

It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors.

Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing Citalopram Capsules, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

5.2 QT-Prolongation and Torsade de Pointes

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 [see Adverse Reactions 6.2)].

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 [see Clinical Pharmacology (12.2)].

Avoid use of Citalopram Capsules in CYP2C19 poor metabolizers, patients receiving concomitant cimetidine or another CYP2C19 inhibitor, patients with hepatic impairment, and patients who are greater than 60 years of age, because Citalopram Capsules are only available in a 30 mg dose strength and dosage adjustments are not possible [see Drug Interactions (7), Use in Specific Populations (8.5, 8.6), Clinical Pharmacology (12.3)].

Citalopram should be avoided in patients with congenital long QT syndrome, bradycardia, hypokalemia or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure unless the benefits outweigh the risks for a particular patient. Citalopram should also not be used in patients who are taking other drugs that prolong the QTc interval [see Drug Interactions (7)]. 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).

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 unless the benefits clearly outweigh the risks for a particular patient (see above). These include those patients with the cardiac conditions noted above, and those taking other drugs that may prolong the QTc interval.

Discontinue Citalopram Capsules in patients who are found to have persistent QTc measurements >500 ms. If patients taking Citalopram Capsules 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.

5.3 Serotonin Syndrome

SSRIs, including Citalopram Capsules, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Contraindications (4), Drug Interactions (7)]. Serotonin syndrome can also occur when these drugs are used alone.

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 gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

The concomitant use of Citalopram Capsules with MAOIs is contraindicated. In addition, do not initiate Citalopram Capsules in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection). If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Citalopram Capsules, discontinue Citalopram Capsules before initiating treatment with the MAOI [see Contraindications (4), Drug Interactions (7)].

Monitor all patients taking Citalopram Capsules for the emergence of serotonin syndrome. Discontinue treatment with Citalopram Capsules and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of Citalopram Capsules with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms.

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