Citalopram Tablets, USP | Citalopram
Citalopram HBr is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula:
The molecular formula is CHBrFNO and its molecular weight is 405.35.
Citalopram HBr occurs as a fine, white to off-white powder.Citalopram HBr is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available as tablets.
Citalopram hydrobromide 10 mg tablets are film-coated, round shaped tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch, croscarmellose sodium, copovidone, magnesium stearate, hypromellose, titanium dioxide, ferric oxide red, ferric oxide yellow, glycerin, and polyethylene glycol.
| Age Range | Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated |
|---|---|
| |
Increases Compared to Placebo |
| <18 |
14 additional cases |
| 18-24 |
5 additional cases |
| |
Decreases Compared to Placebo |
| 25-64 |
1 fewer case |
| ≥65 |
6 fewer cases |
| Body System/Adverse Event | Percentage of Patients Discontinuing Due to Adverse Event |
|
|---|---|---|
| Citalopram (N=1063) |
Placebo (N=446) |
|
|
General
|
|
|
| Asthenia |
1% |
<1% |
|
Gastrointestinal Disorders
|
|
|
| Nausea |
4% |
0% |
| Dry Mouth |
1% |
<1% |
| Vomiting |
1% |
0% |
|
Central and Peripheral
Nervous System Disorders |
|
|
| Dizziness |
2% |
<1% |
|
Psychiatric Disorders
|
|
|
| Insomnia |
3% |
1% |
| Somnolence |
2% |
1% |
| Agitation |
1% |
<1% |
| Body System/Adverse Event | (Percentage of Patients Reporting Event) |
|
|---|---|---|
| Citalopram Tablets (N=1063) |
Placebo (N=446) |
|
| * Events reported by at least 2% of patients treated with citalopram tablets are reported, except for the following events which had an incidence on placebo ≥ citalopram tablets: headache, asthenia, dizziness, constipation, palpitation, vision abnormal, sleep disorder, nervousness, pharyngitis, micturition disorder, back pain. 1 Denominator used was for females only (N=638 citalopram tablets; N=252 placebo). 2 Primarily ejaculatory delay. 3 Denominator used was for males only (N=425 citalopram tablets; N=194 placebo). |
||
|
Autonomic Nervous
System Disorders |
|
|
| Dry Mouth |
20% |
14% |
| Sweating Increased |
11% |
9% |
|
Central & Peripheral
Nervous System Disorders |
|
|
| Tremor |
8% |
6% |
|
Gastrointestinal Disorders
|
|
|
| Nausea |
21% |
14% |
| Diarrhea |
8% |
5% |
| Dyspepsia |
5% |
4% |
| Vomiting |
4% |
3% |
| Abdominal Pain |
3% |
2% |
|
General
|
|
|
| Fatigue |
5% |
3% |
| Fever |
2% |
<1% |
|
Musculoskeletal System
Disorders |
|
|
| Arthralgia |
2% |
1% |
| Myalgia |
2% |
1% |
|
Psychiatric Disorder
|
|
|
| Somnolence |
18% |
10% |
| Insomnia |
15% |
14% |
| Anxiety |
4% |
3% |
| Anorexia |
4% |
2% |
| Agitation |
3% |
1% |
| Dysmenorrhea1
|
3% |
2% |
| Libido Decreased |
2% |
<1% |
| Yawning |
2% |
<1% |
|
Respiratory System
Disorders |
|
|
| Upper Respiratory Tract Infection |
5% |
4% |
| Rhinitis |
5% |
3% |
| Sinusitis |
3% |
<1% |
|
Urogenital
|
|
|
| Ejaculation Disorder2,3
|
6% |
1% |
| Impotence3
|
3% |
<1% |
| Treatment | Citalopram Tablets (425 males) |
Placebo (194 males) |
|---|---|---|
| Abnormal Ejaculation (mostly ejaculatory delay) |
6.1% (males only) |
1% (males only) |
| Libido Decreased |
3.8% (males only) |
<1% (males only) |
| Impotence |
2.8% (males only) |
<1% (males only) |
Manufacturer
Rebel Distributors Corp.
Active Ingredients
Source
- U.S. National Library of Medicine
- DailyMed
- Last Updated: 4 May 2013
Drugs and Medications
Citalopram hydrobromide tablets [Actavis Elizabeth LLC]
CITALOPRAM HYDROBROMIDE TABLETS
Citalopram hydrobromide [REMEDYREPACK INC. ]
Citalopram hydrobromide [Roxane Laboratories, Inc]
CITALOPRAM HYDROBROMIDE Oral Solution, 10 mg/5 mL
Citalopram revised: october 2007 [Watson Laboratories, Inc]
Citalopram Revised: October 2007
Citalopram hydrobromide [Contract Pharmacy Services-PA]
Citalopram Revised: October 2007
Clinical Trials
Brain Effects of Escitalopram and Citalopram Using fMRI
Escitalopram (Lexapro) and citalopram (Celexa) are similar selective serotonin reuptake inhibitors that alter blood flow to the amygdala and other brain structures involved in regulating m...
Pipamperone/Citalopram (PipCit)Versus Citalopram in the Treatment of Major Depressive Disorder(MDD)
The primary objective is to demonstrate whether the addition of pipamperone 5 mg twice daily (bd) to citalopram, 40 mg daily in patients suffering from MDD will improve the efficacy of cit...
Predicting Alcoholics' Treatment Responses to a Selective Serotonin Re-uptake Inhibitor (SSRI)
This study is being done to determine if citalopram is safe and effective in the treatment of alcohol dependence. A second purpose is to evaluate whether alcohol dependent individuals who...
Citalopram for Children With Autism and Repetitive Behavior (STAART Study 1)
This study will determine the efficacy and safety of citalopram compared to placebo in the treatment of children with autism.
Anxiety and Recurrent Abdominal Pain in Children
This study aims to determine whether citalopram is a useful, well-tolerated, and safe treatment for children and adolescents ages 7 to 18 years with functional abdominal pain. The study hy...
PubMed Articles
A Critical Evaluation of the Cardiac Toxicity of Citalopram: Part 1.
In August 2011, the U.S. Food and Drug Administration issued a safety announcement that the antidepressant drug citalopram (Celexa(®)) should not be used at dosages greater than 40 mg per day (or gre...
A Critical Evaluation of the Cardiac Toxicity of Citalopram: Part 2.
In August 2011, the U.S. Food and Drug Administration issued a drug safety communication that the anti-depressant drug citalopram (Celexa(®)) should not be used at dosages greater than 40 mg per day...
CYP2C19 variation and citalopram response.
Variations in cytochrome P450 (CYP) genes have been shown to be associated with both accelerated and delayed pharmacokinetic clearance of many psychotropic medications. Citalopram is metabolized by th...
N-methyl-citalopram: a quaternary selective serotonin reuptake inhibitor.
We describe the synthesis and the pharmacological characterization of a new quaternary selective serotonin reuptake inhibitor (SSRI) N-methyl-citalopram (NMC) with periphery restricted action due to i...
Escitalopram, the S-enantiomer of citalopram, possesses superior efficacy compared to other SSRIs in the treatment of major depression., Escitalopram binds to an allosteric site on the serotonin trans...
