Citalopram Hydrobromide
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- CITALOPRAM HYDROBROMIDE DESCRIPTION
- CLINICAL PHARMACOLOGY
- PHARMACODYNAMICS
- PHARMACOKINETICS
- INDICATIONS & USAGE
- CITALOPRAM HYDROBROMIDE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- LABORATORY TESTS
- DRUG INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- LABOR & DELIVERY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- CITALOPRAM HYDROBROMIDE ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- ANIMAL PHARMACOLOGY & OR TOXICOLOGY
- SPL MEDGUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
BOXED WARNING
Suicidality and Antidepressant DrugsAntidepressants 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 antidpressant 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 beyone 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 ned 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, andPRECAUTIONS: Pediatric Use.)
CITALOPRAM HYDROBROMIDE DESCRIPTION
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
PHARMACOKINETICS
Absorption and Distribution
Metabolism and Elimination
Population Subgroups
DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION
Drug-Drug Interactions
Drug InteractionsPRECAUTIONS
Clinical Efficacy Trials
Comparison of Clinical Trial Results
INDICATIONS & USAGE
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY
CITALOPRAM HYDROBROMIDE CONTRAINDICATIONS
WARNINGSPRECAUTIONS
WARNINGS
Clinical Worsening and Suicide RiskAge RangeDrug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated
PRECAUTIONSDOSAGE AND ADMINISTRATIONDiscontinuation of Treatment with Citalopram Tablets
Screening Patients for Bipolar Disorder
Potential for Interaction with Monoamine Oxidase Inhibitors
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions
PRECAUTIONS
GeneralDiscontinuation 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
LABORATORY TESTS
DRUG INTERACTIONS
WARNINGS-Serotonin SyndromePRECAUTIONS - Drug Interactions
WARNINGS - Serotonin Syndrome
CONTRAINDICATIONSWARNINGS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
CarcinogenesisMutagenesis
Impairment of Fertility
PREGNANCY
Nonteratogenic Effects
WARNINGS
DOSAGE AND ADMINISTRATION
LABOR & DELIVERY
NURSING MOTHERS
PEDIATRIC USE
BOX WARNINGWARNINGS-Clinical Worsening and Suicide RiskGERIATRIC USE
DOSAGE AND ADMINISTRATIONPRECAUTIONS, Hyponatremia
CLINICAL PHARMACOLOGY
DOSAGE AND ADMINISTRATION
CITALOPRAM HYDROBROMIDE ADVERSE REACTIONS
Adverse Findings Observed in Short-Term, Placebo-Controlled Trials
Adverse Events Associated with Discontinuation of Treatment
Body System/Adverse EventPercentage of Patients Discontinuing Due to Adverse EventCitalopram (N=1063)Placebo (N=446)
Adverse Events Occurring at an Incidence of 2% or More Among Citalopram-Treated Patients
Body System/Adverse Event(Percentage of Patients Reporting Event)Citalopram Tablets (N=1063)Placebo (N=446)
Dose Dependency of Adverse Events
Male and Female Sexual Dysfunction with SSRIs
TreatmentCitalopram Tablets (425 males)Placebo (194 males)
Vital Sign Changes
Weight Changes
Laboratory Changes
ECG Changes
Other Events Observed During the Premarketing Evaluation of Citalopram Tablets
ADVERSE REACTIONS
Other Events Observed During the Postmarketing Evaluation of Citalopram Tablets
DRUG ABUSE AND DEPENDENCE
Controlled Substance ClassPhysical and Psychological Dependence
OVERDOSAGE
Human ExperienceManagement of Overdose
DOSAGE & ADMINISTRATION
Initial TreatmentSpecial Populations
Treatment of Pregnant Women During the Third Trimester
PRECAUTIONS
Maintenance Treatment
Clinical TrialsCLINICAL PHARMACOLOGY
Discontinuation of Treatment with Citalopram Tablets
PRECAUTIONS
Switching Patients To or From a Monoamine Oxidase Inhibitor
CONTRAINDICATIONSWARNINGS
HOW SUPPLIED
ANIMAL PHARMACOLOGY & OR TOXICOLOGY
Retinal Changes in RatsCardiovascular Changes in Dogs
SPL MEDGUIDE
Medication Guide-
● all risks and benefits of treatment with antidepressant medicines
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● all treatment choices for depression or other serious mental illness
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● 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.
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● Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
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● 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.
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● thoughts about suicide or dying
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● attempts to commit suicide
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● new or worse depression
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● new or worse anxiety
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● feeling very agitated or restless
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● panic attacks
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● trouble sleeping (insomnia)
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● new or worse irritability
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● acting aggressive, being angry, or violent
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● acting on dangerous impulses
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● an extreme increase in activity and talking (mania)
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● other unusual changes in behavior or mood
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● Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
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● 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.
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● 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.
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● 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.
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● Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Citalopram HydrobromideCitalopram Hydrobromide TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
