Citalopram 10 mg/5mL
Citalopram · SOLUTION · Chartwell RX, LLC
Citalopram is a solution containing citalopram at 10 mg/5mL, taken oral. Manufactured by Chartwell RX, LLC.
Key Facts
- Brand Name
- Citalopram
- Generic Name
- Citalopram
- NDC Code (Product)
62135-540- Manufacturer
- Chartwell RX, LLC
- Strength
- 10 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA077629
- Marketing Start
- 06/14/2006
Recall History
Aidapak Services, LLC
Labeling:Label Mixup; CITALOPRAM Tablet, 10 mg may be potentially mislabeled as OXYBUTYNIN CHLORIDE, Tablet, 5 mg, NDC 00603497521, Pedigree: AD52778_61, EXP: 5/20/2014; COENZYME Q-10, Capsule, 30 mg, NDC 00904501546, Pedigree: W002814, EXP: 6/7/2014.
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Dr. Reddy's Laboratories, Inc.
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Dr. Reddy's Laboratories, Inc.
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Dr. Reddy's Laboratories, Inc.
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
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.
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 tablets are 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 greater than 60 ye…
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 ( 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 (12.2)…
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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 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, a…
Frequently Asked Questions
What is Citalopram used for?
Citalopram contains Citalopram. It is a solution taken oral. Consult your doctor for specific uses.
Is Citalopram a controlled substance?
Citalopram is not classified as a controlled substance by the DEA.
What is the generic name for Citalopram?
The generic name for Citalopram is Citalopram. There are 5 other brand versions of Citalopram.
What is the NDC code for Citalopram 10 mg/5mL?
The NDC (National Drug Code) for Citalopram 10 mg/5mL is 62135-540, listed by Chartwell RX, LLC.