Citalopram Hydrobromide Oral Solution | Citalopram Hydrobromide
| 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 |
| Percentage of Patients Discontinuing Due to Adverse Event |
||
|---|---|---|
| Body System/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% |
| (Percentage of Patients Reporting Event) | ||
|---|---|---|
| Body System/Adverse Event | Citalopram (N=1063) |
Placebo (N=446) |
|
*
Events reported by at least 2% of patients treated with citalopram are reported, except for the following events which had an incidence on placebo ≥ citalopram: 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; N=252 placebo). 2 Primarily ejaculatory delay. 3 Denominator used was for males only (N=425 citalopram; 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 Disorders
|
|
|
| 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 (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) |
Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
Manufacturer
Aurobindo Pharma Limited
Active Ingredients
Source
- U.S. National Library of Medicine
- DailyMed
- Last Updated: 4 May 2013
Drugs and Medications
Citalopram [Rebel Distributors Corp.]
Citalopram Tablets, USP
Citalopram hydrobromide tablets [Actavis Elizabeth LLC]
CITALOPRAM HYDROBROMIDE TABLETS
Citalopram hydrobromide [Roxane Laboratories, Inc]
CITALOPRAM HYDROBROMIDE Oral Solution, 10 mg/5 mL
Citalopram hydrobromide capsules [ALPHAPHARM PTY LTD]
CITALOPRAM HYDROBROMIDE CAPSULES
Citalopram hydrobromide tablets [ALPHAPHARM PTY LTD]
CITALOPRAM HYDROBROMIDE TABLETS
Clinical Trials
- Objective: - To compare the rate and extent of absorption of Citalopram Hydrobromide Tablets 40 mg: Test Product: Citalopram Hydrobromide Tablets 40 mg manufactured b...
- Objective: - The objective of this study is to compare the rate and extent of absorption of the Test Product, Citalopram Hydrobromide 40 mg (Torrent Pharmaceutical Li...
This is a bioequivalence study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited under fasting conditions.
Citalopram in Treating Postmenopausal Women With Hot Flashes
RATIONALE: Citalopram may help relieve hot flashes in women who had or have not had breast cancer. It is not yet known which dose of citalopram is more effective in treating hot flashes in...
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...
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...
