Citalopram Hydrobromide description, usages, side effects, indications, overdosage, supplying and lots more!

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Citalopram Hydrobromide

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

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, andPRECAUTIONS: Pediatric Use.)


CITALOPRAM HYDROBROMIDE DESCRIPTION


Citalopram Hydrobromide









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

WARNINGS

PRECAUTIONS



WARNINGS

Clinical Worsening and Suicide Risk






Age 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

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



























LABORATORY TESTS



DRUG INTERACTIONS



WARNINGS-Serotonin SyndromePRECAUTIONS - Drug Interactions



WARNINGS - Serotonin Syndrome





CONTRAINDICATIONSWARNINGS































CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis


Mutagenesis


Impairment of Fertility



PREGNANCY









Nonteratogenic Effects

WARNINGS



DOSAGE AND ADMINISTRATION

LABOR & DELIVERY



NURSING MOTHERS



PEDIATRIC USE

BOX WARNINGWARNINGS-Clinical Worsening and Suicide Risk

GERIATRIC USE

DOSAGE AND ADMINISTRATION

PRECAUTIONS, 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 Class


Physical and Psychological Dependence



OVERDOSAGE

Human Experience




Management of Overdose





DOSAGE & ADMINISTRATION

Initial Treatment



Special 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



































STORAGE AND HANDLING



ANIMAL PHARMACOLOGY & OR TOXICOLOGY

Retinal Changes in Rats




Cardiovascular Changes in Dogs













SPL MEDGUIDE




  • ●     all risks and benefits of treatment with antidepressant medicines
  • ●     all treatment choices for depression or other serious mental illness






  • ●     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.



  • ●     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


  • ●     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.







PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Citalopram Hydrobromide

Citalopram Hydrobromide

Citalopram Hydrobromide

Citalopram Hydrobromide TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-414(NDC:65862-005)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
citalopram hydrobromide CITALOPRAM 10 mg

Inactive Ingredients

Ingredient Name Strength
COPOVIDONE
STARCH, CORN
CROSCARMELLOSE SODIUM
lactose monohydrate
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
cellulose, microcrystalline
polyethylene glycol 400
titanium dioxide
ferric oxide red
FERRIC OXIDE YELLOW

Product Characteristics

Color Size Imprint Code Shape
orange 5 mm A;05 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-414-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077031 2011-07-22


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Be sure to consult your doctor before taking any medication!
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