CITALOPRAM- citalopram hydrobromide tablet
Preferred Pharmaceuticals Inc.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behaviors 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 is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].
1 INDICATIONS AND USAGE
Citalopram is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
Administer Citalopram once daily, with or without food, at an initial dosage of 20 mg once daily, with an increase to a maximum dosage of 40 mg once daily at an interval of no less than one week.
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
Prior to initiating treatment with Citalopram 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 Recommended Dosage for Specific Populations
The maximum recommended dosage of Citalopram for patients who are greater than 60 years of age, patients with hepatic impairment, and for CYP2C19 poor metabolizers is 20 mg once daily [see Warnings and Precautions (5.2), Clinical Pharmacology (12.3)].
2.4 Dosage Modifications with Concomitant Use of CYP2C19 Inhibitors
The maxium recommended dosage of Citalopram when used concomitantly with a CYP2C19 inhibitor is 20 mg once daily [see Warnings and Precautions (5.2), Drug Interactions (7)].
2.5 Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepressant
At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of therapy with Citalopram. Conversely, at least 14 days must elapse after stopping Citalopram before starting an MAOI antidepressant [see Contraindications (4) and Warnings and Precautions (5.3)].
2.6 Discontinuing Treatment with Citalopram
Adverse reactions may occur upon discontinuation of Citalopram[see Warnings and Precautions (5.6)]. Gradually reduce the dosage rather than stopping Citalopram abruptly whenever possible.
3 DOSAGE FORMS AND STRENGTHS
Citalopram tablets are available as:
- 10mg — Beige, oval, film‐coated. Imprint on one side with “FP”. Imprint on the other side with “10 mg”.
- 20 mg -10 x 10 Unit Dose -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 White, 10 x 10 Unit Dose — 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”
Citalopram 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. Reactions have included angioedema and anaphylaxis [see Adverse Reactions (6.2)].
5 WARNINGS AND PRECAUTIONS
5.1 Suicidal Thoughts and Behavior in Adolescents 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 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. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1.
Age Range *
Drug-Placebo Difference in Number of Patients with Suicidal Thoughts or Behaviors per 1000 Patients Treated
Increases Compared to Placebo
<18 years old
14 additional patients
18-24 years old
5 additional patients
Decreases Compared to Placebo
25-64 years old
1 fewer patient
≥65 years old
6 fewer patients
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 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, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
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