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Citalopram

State of Florida DOH Central Pharmacy

Citalopram Tablets, USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Suicidality and Antidepressant Drugs


Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of citalopram tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.  Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior.  Families and caregivers should be advised of the need for close observation and communication with the prescriber.  Citalopram is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

CITALOPRAM DESCRIPTION



Citalopram
20222





CLINICAL PHARMACOLOGY

Pharmacodynamics


In  vitro  in vivo

1A, 2A12,121

Pharmacokinetics


Absorption and Distribution


Metabolism and Elimination




In vitro

In vitro

Population Subgroups


DOSAGE AND ADMINISTRATION

-

- DOSAGE AND ADMINISTRATION

-

Drug-Drug Interactions


In vitroin vivoin vivo

Drug Interactions PRECAUTIONS

Clinical Efficacy Trials






Comparison of Clinical Trial Results


CITALOPRAM INDICATIONS AND USAGE




CLINICAL PHARMACOLOGY





CLINICAL PHARMACOLOGY

CITALOPRAM CONTRAINDICATIONS


WARNINGS

PRECAUTIONS

WARNINGS

Clinical Worsening and Suicide Risk






Table 1
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





All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.





PRECAUTIONS DOSAGE AND ADMINISTRATION—Discontinuation of Treatment with Citalopram Tablets

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers.Such monitoring should include daily observation by families and caregivers.

Screening Patients for Bipolar Disorder


Potential for Interaction with Monoamine Oxidase Inhibitors


In patients receiving serotonin reuptake inhibitor drugs in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued SSRI treatment and have been started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Furthermore, limited animal data on the effects of combined use of SSRIs and MAOIs suggest that these drugs may act synergistically to elevate blood pressure and evoke behavioral excitation. Therefore, it is recommended that citalopram tablets should not be used in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI. Similarly, at least 14 days should be allowed after stopping citalopram tablets before starting an MAOI.

Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions






PRECAUTIONS

General

Discontinuation of Treatment with Citalopram Tablets




DOSAGE AND ADMINISTRATION

Abnormal Bleeding




Hyponatremia


Geriatric Use

Activation of Mania/Hypomania


Seizures


Interference with Cognitive and Motor Performance


Use in Patients with Concomitant Illness






DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATION

Information for Patients
























Clinical Worsening and Suicide Risk

Laboratory Tests


Drug Interactions




WARNINGS-Serotonin Syndrome PRECAUTIONS - Drug Interactions



WARNINGS - Serotonin Syndrome

-



- CONTRAINDICATIONS WARNINGS



max



-

max

-

-

-

-

-

-max

- In vitro

-

- In vitro

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis


22

Mutagenesis


in vitroin vitroin vitro in vitro/in vivoin vitro in vivo

Impairment of Fertility


2

Pregnancy






222

222

Nonteratogenic Effects


WARNINGS



DOSAGE AND ADMINISTRATION

Labor and Delivery


Nursing Mothers


Pediatric Use


 BOX WARNING WARNINGS–-Clinical Worsening and Suicide Risk

Geriatric Use


DOSAGE AND ADMINISTRATION

PRECAUTIONS, Hyponatremia

CLINICAL PHARMACOLOGY

DOSAGE AND ADMINISTRATION

CITALOPRAM ADVERSE REACTIONS






Adverse Findings Observed in Short-Term, Placebo-Controlled Trials

Adverse Events Associated with Discontinuation of Treatment


TABLE 2

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%

Adverse Events Occurring at an Incidence of 2% or More Among Citalopram-Treated Patients


Table 3



TABLE 3
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).
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%

Dose Dependency of Adverse Events


Male and Female Sexual Dysfunction with SSRIs







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)







Vital Sign Changes


Weight Changes


Laboratory Changes


ECG Changes


Other Events Observed During the Premarketing Evaluation of Citalopram Tablets


ADVERSE REACTIONS Table 3



Cardiovascular - Frequent:Infrequent:Rare:

Central and Peripheral Nervous System Disorders - Frequent:Infrequent:Rare:

Endocrine Disorders - Rare:

Gastrointestinal Disorders - Frequent:Infrequent:Rare:

General Infrequent: Rare:

Hemic and Lymphatic Disorders - Infrequent:Rare:

Metabolic and Nutritional Disorders - Frequent:Infrequent:Rare:

Musculoskeletal System Disorders - InfrequentRare

Psychiatric Disorders - Frequent:Infrequent:Rare:

Reproductive Disorders/Female* - Frequent:Infrequent

*

Respiratory System Disorders - Frequent: Infrequent: Rare:

Skin and Appendages Disorders - Frequent:Infrequent:Rare:

Special Senses - Frequent:Infrequent:Rare:

Urinary System Disorders - Frequent:Infrequent:Rare:

Other Events Observed During the Postmarketing Evaluation of Citalopram Tablets


DRUG ABUSE AND DEPENDENCE

Controlled Substance Class


Physical and Psychological Dependence


OVERDOSAGE

Human Experience




Management of Overdose




CITALOPRAM DOSAGE AND ADMINISTRATION

Initial Treatment




Special Populations




Treatment of Pregnant Women During the Third Trimester


PRECAUTIONS

Maintenance Treatment


Clinical Trials CLINICAL PHARMACOLOGY

Discontinuation of Treatment with Citalopram Tablets


PRECAUTIONS

Switching Patients To or From a Monoamine Oxidase Inhibitor


CONTRAINDICATIONS WARNINGS

HOW SUPPLIED




10 mg Tablets –
20 mg Tablets –
40 mg Tablets –

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


Store at

ANIMAL TOXICOLOGY

Retinal Changes in Rats


22

Cardiovascular Changes in Dogs


2


Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited

This Product was Repackaged By:

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

Medication Guide


Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Talk to your, or your family member’s, healthcare provider about:
  • all risks and benefits of treatment with antidepressant medicines
  • all treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

  • Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  • Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
  • How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? 
  • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

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:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood 

What else do I need to know about antidepressant medicines?
  • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.






Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited

This Product was Repackaged By:

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg Unit-of-Use Pack (30 Tablets)


NDC 53808-0227-1
Citalopram Tablets, USP
40 mg
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
Rx only                   30 Tablets
PLACE PHARMACY LABEL HERE
DO NOT WRAP LABEL AROUND EDGES
AUROBINDO
Citalopram

Citalopram

Citalopram Hydrobromide TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:53808-0227(NDC:65862-007)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
citalopram hydrobromide CITALOPRAM 40 mg

Inactive Ingredients

Ingredient Name Strength
COPOVIDONE
STARCH, CORN
CROSCARMELLOSE SODIUM
lactose monohydrate
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 CPS)
cellulose, microcrystalline
polyethylene glycol 400
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 12 mm A;0;7 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53808-0227-1 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077031 2009-07-01


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Be sure to consult your doctor before taking any medication!
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