Drugplain

Citalopram Hydrobromide 10 mg/5mL

Citalopram Hydrobromide · SOLUTION · Aurobindo Pharma Limited

1 Recall on Record
Plain English

Citalopram Hydrobromide is a solution containing citalopram hydrobromide at 10 mg/5mL, taken oral. Manufactured by Aurobindo Pharma Limited.

Key Facts

Brand Name
Citalopram Hydrobromide
Generic Name
Citalopram Hydrobromide
NDC Code (Product)
65862-074
Manufacturer
Aurobindo Pharma Limited
Strength
10 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA077812
Marketing Start
08/28/2006

Recall History

1 Recall on Record
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged between 01/05/12 through 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue6,905 reports
nausea5,956 reports
drug ineffective5,461 reports
headache5,092 reports
toxicity to various agents5,034 reports
diarrhoea4,778 reports
fall4,418 reports
dizziness4,382 reports
pain4,362 reports
off label use4,288 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )] . Citalopram 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 citalopram tablets, reduce dosage gradually ( 2.4 , 5.6 ) . 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 grea…

Contraindications

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 )] . • 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 ) .

Drug Interactions

7 DRUG INTERACTIONS Table 5 presents clinically important drug interactions with citalopram. Table 5: Clinically Important Drug Interactions with Citalopram Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of SSRIs, including citalopram, and MAOIs increases the risk of serotonin syndrome. Intervention Citalopram 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 citalopram 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 citalopram alone [see Clinical Pharmacology ( 12.2 )]. Intervention: Citalopram 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 citalopram with drugs that prolong QT can cause additional QT prolongation compared to the use of citalopram alone [see Clinical Pharmacology …

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 Torrent Pharma Inc . at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under w…

Frequently Asked Questions

What is Citalopram Hydrobromide used for?

Citalopram Hydrobromide contains Citalopram Hydrobromide. It is a solution taken oral. Consult your doctor for specific uses.

Is Citalopram Hydrobromide a controlled substance?

Citalopram Hydrobromide is not classified as a controlled substance by the DEA.

What is the generic name for Citalopram Hydrobromide?

The generic name for Citalopram Hydrobromide is Citalopram Hydrobromide. There are 4 other brand versions of Citalopram Hydrobromide.

What is the NDC code for Citalopram Hydrobromide 10 mg/5mL?

The NDC (National Drug Code) for Citalopram Hydrobromide 10 mg/5mL is 65862-074, listed by Aurobindo Pharma Limited.

Product NDC

65862-074

Package NDC

65862-074-24

Other Citalopram Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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