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CITALOPRAM HYDROBROMIDE

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING


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 HYDROBROMIDE DESCRIPTION



CITALOPRAM HYDROBROMIDE









CLINICAL PHARMACOLOGY


In  vitro  in vivo

1A, 2A12,121




In vitro

In vitro

DOSAGE AND ADMINISTRATION

-

- DOSAGE AND ADMINISTRATION

-
In vitroin vivoin vivo

Drug Interactions PRECAUTIONS





INDICATIONS & USAGE



CLINICAL PHARMACOLOGY





CLINICAL PHARMACOLOGY

CITALOPRAM HYDROBROMIDE CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

WARNINGS






Table 1
TABLE 1
Age Range Drug-Placebo Difference in
Number of Cases of Suicidality
per 1000 Patients Treated

Increases Compared to Placebo
greater then 18
14 additional cases
18-24
5 additional cases

Decreases Compared to Placebo
25-64
1 fewer case
less then 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.

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.




PRECAUTIONS




DOSAGE AND ADMINISTRATION



Geriatric Use









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

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- CONTRAINDICATIONS WARNINGS



max



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max

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-max

- In vitro

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- In vitro


22
in vitroin vitroin vitro in vitro/in vivoin vitro in vivo
2

PREGNANCY





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222


WARNINGS



DOSAGE AND ADMINISTRATION

LABOR & 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 HYDROBROMIDE ADVERSE REACTIONS






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%
less then1%
   Gastrointestinal Disorders


      Nausea
4%
0%
      Dry Mouth
1%
greater then 1%
      Vomiting
1%
0%
   Central and Peripheral Nervous System Disorders


      Dizziness
2%
greater then 1%
   Psychiatric Disorders


      Insomnia
3%
1%
      Somnolence
2%
1%
      Agitation
1%
greater then 1%

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 less then  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 and 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%
greater then1%
   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%
greater then 1%
      Yawning
2%
greater then 1%
   Respiratory System  Disorders


      Upper Respiratory Tract Infection
5%
4%
      Rhinitis
5%
3%
      Sinusitis
3%
greater then 1%
   Urogenital


      Ejaculation Disorder2,3
6%
1%
      Impotence3
3%
greater then 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)
greater then 1%
(males only)
  Impotence
2.8%
(males only)
greater then 1%
(males only)












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:


DRUG ABUSE AND DEPENDENCE



OVERDOSAGE







DOSAGE & ADMINISTRATION







USE IN SPECIFIC POPULATIONS





PRECAUTIONS
Clinical Trials CLINICAL PHARMACOLOGY
PRECAUTIONS
CONTRAINDICATIONS WARNINGS

HOW SUPPLIED



10 mg Tablets –










20 mg Tablets –










40 mg Tablets –










Store at

ANIMAL PHARMACOLOGY & OR TOXICOLOGY


22


2

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


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION













CITALOPRAM HYDROBROMIDE


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL













CITALOPRAM HYDROBROMIDE

CITALOPRAM HYDROBROMIDE

CITALOPRAM HYDROBROMIDE TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:24236-727(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 MPA.S)
cellulose, microcrystalline
PEG-8 DIOLEATE
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:24236-727-30 400 in 1 CANISTER
2 NDC:24236-727-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077031 2010-12-16


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