Celexa 40 mg/1

citalopram · TABLET, FILM COATED · Allergan, Inc.

No Recall History

Plain English

Celexa is a tablet, film coated containing citalopram at 40 mg/1, taken oral. Manufactured by Allergan, Inc..

Key Facts

Brand Name: Celexa
Generic Name: citalopram
NDC Code (Product): 0456-4040
Manufacturer: Allergan, Inc.
Strength: 40 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: NDA020822
Marketing Start: 07/17/1998

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue7,447 reports

nausea7,027 reports

drug ineffective6,168 reports

diarrhoea5,359 reports

headache5,299 reports

dizziness4,761 reports

pain4,723 reports

fall4,692 reports

dyspnoea4,608 reports

anxiety4,594 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE CELEXA is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )] . CELEXA is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).

Dosage & Administration

2 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 CELEXA, reduce dosage gradually ( 2.4 , 5.6 ). 2.1 Recommended Dosage Administer CELEXA 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 CELEXA Prior to initiating treatment with CELEXA 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 Speci fic Populations The maximum recommended dosage of CELEXA for patients who are greater than 60 years of age, patients with hepatic impairment, and for …

Contraindications

4 CONTRAINDICATIONS CELEXA 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 CELEXA. Reactions have included angioedema and anaphylaxis [see Adverse Reactions ( 6.2 ) ]. 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 CELEXA ( 4 ).

Drug Interactions

7 DRUG INTERACTIONS Table 5 presents clinically important drug interactions with CELEXA. Table 5: Clinically Important Drug Interactions with CELEXA Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of SSRIs, including CELEXA, and MAOIs increases the risk of serotonin syndrome. Intervention CELEXA is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration ( 2.5 ), Contraindications ( 4 ), Warnings and Precautions ( 5.3 )] . Pimozide Clinical Impact: Concomitant use of CELEXA with pimozide increases plasma concentrations of pimozide, a drug with a narrow therapeutic index, and may increase the risk of QT prolongation and/or ventricular arrhythmias compared to use of CELEXA alone [see Clinical Pharmacology ( 12.2 )]. Intervention: CELEXA is contraindicated in patients taking pimozide [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )]. Drugs that Prolong the QTc Interval Clinical Impact: Concomitant use of CELEXA with drugs that prolong QT can cause additional QT prolongation compared to the use of CELEXA alone [see Clinical Pharmacology ( 12.2 )]. Intervention: Avoid conco…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity reactions [see Contraindications ( 4 )] Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions ( 5.1 )] QT-prolongation and torsade de pointes [see Warnings and Precautions ( 5.2 )] Serotonin syndrome [see Warnings and Precautions ( 5.3 )] Increased risk of bleeding [see Warnings and Precautions ( 5.4 )] Activation of mania or hypomania [see Warnings and Precautions ( 5.5 )] Discontinuation syndrome [see Warnings and Precautions ( 5.6 )] Seizures [see Warnings and Precautions ( 5.7 )] Angle-closure glaucoma [see Warnings and Precautions ( 5.8 )] Hyponatremia [see Warnings and Precautions ( 5.9 )] Sexual Dysfunction [see Warnings and Precautions ( 5.10 )] Most common adverse reaction (incidence ≥ 5% and twice placebo) is ejaculation disorder (primarily ejaculation delay) ( 6.1 ) . To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse re…

Frequently Asked Questions

What is Celexa used for?

Celexa contains citalopram. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Celexa a controlled substance?

Celexa is not classified as a controlled substance by the DEA.

What is the generic name for Celexa?

The generic name for Celexa is citalopram. There are 12 other brand versions of citalopram.

What is the NDC code for Celexa 40 mg/1?

The NDC (National Drug Code) for Celexa 40 mg/1 is 0456-4040, listed by Allergan, Inc..

Product NDC

0456-4040

Package NDC

0456-4040-01

Other Citalopram Brands

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