Citalopram Hydrobromide
Sandoz Inc.
Aurobindo Pharma Limited
Citalopram Tablets USP
FULL PRESCRIBING INFORMATION: CONTENTS*
- Suicidality and Antidepressant Drugs
- CITALOPRAM HYDROBROMIDE DESCRIPTION
- CLINICAL PHARMACOLOGY
- CITALOPRAM HYDROBROMIDE INDICATIONS AND USAGE
- CITALOPRAM HYDROBROMIDE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- CITALOPRAM HYDROBROMIDE ADVERSE REACTIONS
- Adverse Findings Observed in Short-Term, Placebo-Controlled Trials
- Adverse Events Occurring at an Incidence of 2% or More Among Citalopram Hydrobromide-Treated Patients
- Other Events Observed During the Premarketing Evaluation of Citalopram Hydrobromide
- Other Events Observed During the Postmarketing Evaluation of Citalopram Hydrobromide
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- CITALOPRAM HYDROBROMIDE DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- ANIMAL TOXICOLOGY
- Medication Guide
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg (100 Tablet Bottle)
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 HYDROBROMIDE DESCRIPTION
Citalopram hydrobromide is an orally administered selective serotonin reuptake inhibitor (hydrobromide
20222
CLINICAL PHARMACOLOGY
Pharmacodynamics
In vitro in vivo -
1A2A12α1α2β1muscarinic
Pharmacokinetics
Absorption and Distribution
Metabolism and Elimination
’In vitro metabolites
In vitro
Population Subgroups
Age
≥ DOSAGE AND ADMINISTRATION
Gender
Reduced Hepatic Function
DOSAGE AND ADMINISTRATION
Reduced Renal Function
Drug-Drug Interactions
In vitro in vivo in vivo
, Drug Interactions PRECAUTIONS
Clinical Efficacy Trials
DSMscale
Comparison of Clinical Trial Results
CITALOPRAM HYDROBROMIDE INDICATIONS AND USAGE
Citalopram tablets are indicated for the treatment of depression.
outpatientsDSM- CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY
CITALOPRAM HYDROBROMIDE CONTRAINDICATIONS
WARNINGS
PRECAUTIONS, Pimozide
WARNINGS
Clinical Worsening and Suicide Risk
-, however,during the early phases of treatment.antidepressant drugs (SSRIs and others) showed that these drugs increasechildren, adolescents and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. 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 with antidepressants compared to placebo in adults aged 65 and older.
of suicidalitin the younger patientThere were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1,000 patients treated) are provided in Table 1 .
| Age Range | Drug-Placebo Difference in Number of Cases of Suicidality per 1,000 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
|
the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.
However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
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
are
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 a 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 hydrobromide should not be used in combination with a MAOI, or within 14 days of discontinuing treatment with a MAOI. Similarly, at least 14 days should be allowed after stopping citalopram hydrobromide before starting a MAOI.
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions
PRECAUTIONS
General
DOSAGE AND ADMINISTRATION
Hyponatremia
Geriatric Use
product’s
judgment
produce
DOSAGE AND ADMINISTRATION
numbers DOSAGE AND ADMINISTRATION
Information for Patients
-
about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions”
Clinical Worsening and Suicide Risk
look’’
Laboratory Tests
Drug Interactions
Serotonergic Drugs
WARNINGS, Serotonin Syndrome PRECAUTIONS, Drug Interactions
WARNINGS, Serotonin Syndrome
CONTRAINDICATIONS WARNINGS
thatwith
maxfindings
Pimozide
max
pharmacokinetics
max
In vitro
In vitro
Carcinogenesis, Mutagenesis, Impairment Of Fertility
month2imes2
in vitro Salmonellain vitro in vitro in vitroin vivo in vitroin vivo
≥2
Pregnancy
2,-2,2
22≥2
Pregnancy-Nonteratogenic Effects
WARNINGS ).Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective, case-control study of 377 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. There is currently no corroborative evidence regarding the risk for PPHN following exposure to SSRIs in pregnancy; this is the first study that has investigated the potential risk. The study did not include enough cases with exposure to individual SSRIs to determine if all SSRIs posed similar levels of PPHN risk.
both DOSAGE AND ADMINISTRATION Physicians should note that in a prospective longitudinal study of 201 women with a history of major depression who were euthymic at the beginning of pregnancy, women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication.
Labor and Delivery
The effect of citalopram hydrobromide on labor and delivery in humans is unknown.
Nursing Mothers
As has been found to occur with many other drugs, citalopram is excreted in human breast milk. There have been two reports of infants experiencing excessive somnolence, decreased feeding and weight loss in association with breast feeding from a citalopram-treated mother; in one case, the infant was reported to recover completely upon discontinuation of citalopram by its mother, and in the second case, no follow-up information was available. The decision whether to continue or discontinue either nursing or citalopram hydrobromide therapy should take into account the risks of citalopram exposure for the infant and the benefits of citalopram hydrobromide treatment for the mother.
Pediatric Use
Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS, Clinical Worsening and Suicide Risk ). Two placebo-controlled trials in 407 pediatric patients with MDD have been conducted with citalopram tablets and the data were not sufficient to support a claim for use in pediatric patients. Anyone considering the use of citalopram tablets in a child or adolescent must balance the potential risks with the clinical need.
Geriatric Use
DOSAGE AND ADMINISTRATION
PRECAUTIONS, Hyponatremia
CLINICAL PHARMACOLOGY
DOSAGE AND ADMINISTRATION .
CITALOPRAM HYDROBROMIDE ADVERSE REACTIONS
postmarketing
Adverse Findings Observed in Short-Term, Placebo-Controlled Trials
Adverse Events Associated with Discontinuation of Treatment
Table 2.
| Body System/ Adverse Event |
Percentage of Patients Discontinuing Due to Adverse Event |
|
|---|---|---|
| Citalopram (N=1,063) |
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 Hydrobromide-Treated Patients
3
Table 3).
| Body System/Adverse Event | Percentage of Patients Reporting Event |
|
|---|---|---|
| Citalopram Hydrobromide (N=1,063) |
Placebo (N=446) |
|
|
* Events reported by at least 2% of patients treated with citalopram hydrobromide are reported, except for the following events which had an incidence on placebo ≥ citalopram hydrobromide: 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 hydrobromide; N=252 placebo). 2 Primarily ejaculatory delay. 3 Denominator used was for males only (N=425 citalopram hydrobromide; 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% |
<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% |
Dose Dependency of Adverse Events
’<
Male and Female Sexual Dysfunction with SSRIs
| Treatment | Citalopram Hydrobromide (425 males) |
Placebo
(194 males) |
|---|---|---|
| Abnormal Ejaculation (mostly ejaculatory delay) |
6.1% (males only) |
1% (males only) |
| Decreased Libido |
3.8% (males only) |
<1% (males only) |
| Impotence |
2.8% (males only) |
<1% (males only) |
Vital Sign Changes
Weight Changes
Laboratory Changes
ECG Changes
citalopram hdrobromide
Other Events Observed During the Premarketing Evaluation of Citalopram Hydrobromide
ADVERSE REACTIONS 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:purpuraRare:
Metabolic and Nutritional Disorders: Frequent:Infrequent: Rare:
Musculoskeletal System Disorders: Infrequent:Rare:
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 Hydrobromide
glaucoma,thrombocytopenia
DRUG ABUSE AND DEPENDENCE
Controlled Substance Class
Physical and Psychological Dependence
-
OVERDOSAGE
Human Experience
overdoses
very rare casesAcute renal failure has been very rarely reported accompanying overdose.
Management of Overdose
any
CITALOPRAM HYDROBROMIDE DOSAGE AND ADMINISTRATION
Initial Treatment
Special Populations
Treatment of Pregnant Women During the Third Trimester
PRECAUTIONS
Maintenance Treatment
CLINICAL PHARMACOLOGY, Clinical Trials
Discontinuation of Treatment with Citalopram Tablets
PRECAUTIONS continue
Switching Patients to or from a Monoamine Oxidase Inhibitor
CONTRAINDICATIONS WARNINGS
HOW SUPPLIED
10 mg
20 mg“”“0”“6”
40 mg“”“0”“7”
°°
ANIMAL TOXICOLOGY
Retinal Changes in Rats
24 times,time2
Cardiovascular Changes in Dogs
2dogs
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.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Manufactured in
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg (100 Tablet Bottle)
NDC 0185-0373-01
Citalopram Tablets, USP
40 mg
PHARMACIST: Please dispense with
Medication Guide provided separately.
Rx only
100 Tablets
SANDOZ
Citalopram HydrobromideCitalopram Hydrobromide TABLET, FILM COATED
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Citalopram HydrobromideCitalopram Hydrobromide TABLET, FILM COATED
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Citalopram HydrobromideCitalopram Hydrobromide TABLET, FILM COATED
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
