Citalopram 40 mg Tablets — Generic For Celexa — Mylan

These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS.

CITALOPRAM tablets, for oral use

Initial U.S. Approval: 1998

Warning: Suicidal Thoughts And Behaviors

See full prescribing information for complete boxed warning.

Recent Major Changes

Warnings and Precautions (5.3, 5.4) 08/2023

Indications And Usage

Citalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults (1).

Dosage And Administration

Dosage Forms And Strengths

Tablets: 10 mg; 20 mg, scored; and 40 mg, scored (3)

Contraindications

Warnings And Precautions

• (5.3, 5.4) 08/2023 INDICATIONS AND USAGE Citalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults (1). DOSAGE AND ADMINISTRATION
• Administer once daily with or without food (2).
• Initial dosage is 20 mg once daily; after one week may increase to maximum dosage of 40 mg once daily (2.1).
• Patients greater than 60 years of age, patients with hepatic impairment, and CYP2C19 poor metabolizers: maximum recommended dosage is 20 mg once daily (2.2).
• When discontinuing citalopram tablets, reduce dosage gradually (2.4, 5.6). DOSAGE FORMS AND STRENGTHS Tablets: 10 mg; 20 mg, scored; and 40 mg, scored (3) CONTRAINDICATIONS
• Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of discontinuing a MAOI (4).
• Concomitant use of pimozide (4).
• Known hypersensitivity to citalopram or any of the inactive ingredients of citalopram tablets (4). WARNINGS AND PRECAUTIONS

• (5.3, 5.4) 08/2023 INDICATIONS AND USAGE Citalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults (1). DOSAGE AND ADMINISTRATION
• Administer once daily with or without food (2).
• Initial dosage is 20 mg once daily; after one week may increase to maximum dosage of 40 mg once daily (2.1).
• Patients greater than 60 years of age, patients with hepatic impairment, and CYP2C19 poor metabolizers: maximum recommended dosage is 20 mg once daily (2.2).
• When discontinuing citalopram tablets, reduce dosage gradually (2.4, 5.6). DOSAGE FORMS AND STRENGTHS Tablets: 10 mg; 20 mg, scored; and 40 mg, scored (3) CONTRAINDICATIONS
• Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of discontinuing a MAOI (4).
• Concomitant use of pimozide (4).
• Known hypersensitivity to citalopram or any of the inactive ingredients of citalopram tablets (4). WARNINGS AND PRECAUTIONS

Adverse Reactions

Most common adverse reaction (incidence ≥ 5% and twice placebo) is ejaculation disorder (primarily ejaculation delay) (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

CYP2C19 Inhibitors: Citalopram tablets 20 mg daily is the maximum recommended dosage for patients taking concomitant CYP2C19 inhibitors (5.2, 7).

Use In Specific Populations

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 6/2024