CITALOPRAM HYDROBROMIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Citalopram Hydrobromide (UNII: I1E9D14F36) (Citalopram - UNII:0DHU5B8D6V)

Available from:

Atlantic Biologicals Corps

INN (International Name):

Citalopram Hydrobromide

Composition:

Citalopram 10 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Citalopram Oral Solution USP is indicated for the treatment of depression. The efficacy of citalopram Oral Solution USP in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM- III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram Oral Solution USP in hospitalized depressed patients has not been adequate

Product summary:

NDC:17856-0540-2 in a CUP of 10 SOLUTIONS

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CITALOPRAM HYDROBROMIDE - CITALOPRAM HYDROBROMIDE SOLUTION
Atlantic Biologicals Corps
----------
MEDICATION GUIDE
Read the Medication Guide that comes with Citalopram Oral Solution
before you start taking it and each
time you get a refill. There may be new information. This Medication
Guide does not take the place of
talking to your healthcare provider about your medical condition or
treatment. Talk with your healthcare
provider if there is something you do not understand or want to learn
more about. Citalopram Oral
Solution
Citalopram Oral Solution and other antidepressant medicines may cause
serious side effects, including: :
What is the most important information I should know about Citalopram
Oral Solution?
1. Suicidal thoughts or actions
•
in some children, teenagers, or young adults within the . Citalopram
Oral Solution and other
antidepressant medicines may increase suicidal thoughts or
actionsfirst few months of treatment or
when the dose is changed
•
Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
•
Watch for these changes and call your healthcare provider right away
if you notice:
•
New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if
severe.
•
Pay particular attention to such changes when Citalopram Oral Solution
is started or when
the dose is changed.
Keep all follow-up visits with your healthcare provider and call
between visits if you are worried about
symptoms.
: Call your healthcare provider right away if you have any of the
following symptoms, or call 911 if an
emergency, especially if they are new, worse, or worry you
•
attempts to commit suicide
•
acting on dangerous impulses
•
acting aggressive or violent
•
thoughts about suicide or dying
•
new or worse depression
•
new or worse anxiety or panic attacks
•
feeling agitated, restless, angry or irritable
•
trouble sleeping
•
an increase in activity or talking more than what is normal for you
•
other unusual changes in behavi

Summary of Product characteristics

CITALOPRAM HYDROBROMIDE - CITALOPRAM HYDROBROMIDE SOLUTION
ATLANTIC BIOLOGICALS CORPS
----------
CITALOPRAM ORAL SOLUTION, USP
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 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. (( WARNINGS:
CLINICAL WORSENING
AND SUICIDE RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, PRECAUTIONS,
PEDIATRIC
USE.)
_SEEAND_
DESCRIPTION
Citalopram HBr is an orally administered selective serotonin reuptake
inhibitor (SSRI) with a chemical
structure unrelated to that of other SSRI's or of tricyclic,
tetracyclic, or other available antidepressant
agents. Citalopram HBr is a racemic bicyclic phthalane derivative
designated (±)-1-(3-
dimethylaminopropyl)-1-(4-flurophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile,
HBr with the
following structural formula:
The molecular formula is C H BrFN O and its molecular weight is
405.35.
Citalopram HBr occurs as a fine, white to off-white powder. Citalopram
HBr is sparingly soluble in
water and soluble in ethanol.
Citalopram hydrobr