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Citalopram Tablets, USP | Citalopram

05:23 EDT 27th August 2014 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.
IMAGE citalopram-str.jpg
TABLE 1
   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
TABLE 2 Adverse Events Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled, Depression Trials
   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%
TABLE 3 Treatment-Emergent Adverse Events: Incidence in Placebo-Controlled Clinical Trials*
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).
Primarily ejaculatory delay.
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)

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0227-1 40 mg 30 Tablets in a Blister Pack WHITE 65862-007

This Product was Repackaged By:

State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

This Product was Repackaged By:

State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

IMAGE Citalopram 40mg(Aurobindo).jpg

Manufacturer

State of Florida DOH Central Pharmacy

Active Ingredients

Source

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PubMed Articles [29 Associated PubMed Articles listed on BioPortfolio]

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