Citalopram Hydrobromide

CITALOPRAM HYDROBROMIDE- citalopram hydrobromide tablet
Torrent Pharmaceuticals Limited

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 tablets are not approved for use in pediatric patients [see Use in Specific Populations ( 8.4)] .

1 INDICATIONS AND USAGE

Citalopram tablets are 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 tablets 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 Tablets

Prior to initiating treatment with citalopram tablets 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 tablets 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 tablets 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 tablets. Conversely, at least 14 days must elapse after stopping citalopram tablets before starting an MAOI antidepressant [see Contraindications ( 4) and Warnings and Precautions ( 5.3)] .

2.6 Discontinuing Treatment with Citalopram tablets

Adverse reactions may occur upon discontinuation of citalopram tablets [see Warnings and Precautions ( 5.6)] . Gradually reduce the dosage rather than stopping citalopram tablets abruptly whenever possible.

3 DOSAGE FORMS AND STRENGTHS

Citalopram tablets, USP are available as:
• 10 mg: Tan coloured, round shaped, biconvex film coated tablets with ‘10’ debossed on one side and plain on the other side.
• 20 mg: Tan coloured, oval shaped, biconvex film coated tablets with ‘2│0’ debossed (‘2’ on left side and ‘0’ on right side of the break line) on one side and ‘1010’ on the other side.
• 40 mg: Tan coloured, oval shaped, biconvex film coated tablets with ‘4│0’ debossed (‘4’ on left side and ‘0’ on right side of the break line) on one side and ‘1011’ on the other side

4 CONTRAINDICATIONS

Citalopram tablets are 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 tablets. 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 indentified 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 1,000 patients treated are provided in Table 1.

Table 1: Risk Differences of the Number of Patients with Suicidal Thoughts and Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult 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 patients

18 to 24 years old

5 additional patients

Decreases Compared to Placebo

25 to 64 years old

1 fewer patient

≥65 years old

6 fewer patients

*Citalopram tablets are not approved for use in pediatric 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 tablets, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

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