CITALOPRAM HYDROBROMIDE
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- CITALOPRAM HYDROBROMIDE DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- CITALOPRAM HYDROBROMIDE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- LABORATORY TESTS
- DRUG INTERACTIONS
- PREGNANCY
- LABOR & DELIVERY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- CITALOPRAM HYDROBROMIDE ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- USE IN SPECIFIC POPULATIONS
- HOW SUPPLIED
- ANIMAL PHARMACOLOGY & OR TOXICOLOGY
- MEDICATION GUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
CLINICAL PHARMACOLOGY
In vitro in vivo
1A, 2A12,121
In vitro
In vitro
DOSAGE AND ADMINISTRATION
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- DOSAGE AND ADMINISTRATION
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In vitroin vivoin vivo
Drug Interactions PRECAUTIONS
INDICATIONS & USAGE
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY
CITALOPRAM HYDROBROMIDE CONTRAINDICATIONS
WARNINGSPRECAUTIONS
WARNINGS
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
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- In vitro
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- In vitro
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in vitroin vitroin vitro in vitro/in vivoin vitro in vivo
2
PREGNANCY
222
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WARNINGS
DOSAGE AND ADMINISTRATION
LABOR & DELIVERY
NURSING MOTHERS
PEDIATRIC USE
BOX WARNING WARNINGS–-Clinical Worsening and Suicide RiskGERIATRIC USE
DOSAGE AND ADMINISTRATIONPRECAUTIONS, Hyponatremia
CLINICAL PHARMACOLOGY
DOSAGE AND ADMINISTRATION
CITALOPRAM HYDROBROMIDE ADVERSE REACTIONS
TABLE 2
| 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
| 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 ActionsTalk 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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDE TABLET, FILM COATED
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
