CITALOPRAM solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

CITALOPRAM HYDROBROMIDE (UNII: I1E9D14F36) (CITALOPRAM - UNII:0DHU5B8D6V)

Disponibbli minn:

Hikma Pharmaceuticals USA Inc.

INN (Isem Internazzjonali):

CITALOPRAM HYDROBROMIDE

Kompożizzjoni:

CITALOPRAM 10 mg in 5 mL

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Citalopram oral solution is indicated for the treatment of depression. The efficacy of citalopram oral solution in the treatment of depression was established in 4 to 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 in hospitalized depressed patients has not been adequately studie

Sommarju tal-prodott:

Citalopram Oral Solution, USP 10 mg per 5 mL oral solution is supplied as a (peppermint flavored) clear, colorless oral solution. NDC 0054-0062-58: Bottle of 240 mL Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

CITALOPRAM- CITALOPRAM SOLUTION
Hikma Pharmaceuticals USA Inc.
----------
MEDICATION GUIDE
Citalopram Oral Solution, USP
(si TAL o pram)
Rx only
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.
What is the most important information I should know about citalopram?
Citalopram and other antidepressant medicines may cause serious side
effects, including:
1. Suicidal thoughts or actions:
•
Citalopram and other antidepressant medicines may increase suicidal
thoughts or actions in some
children, teenagers, or young adults within the first 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 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 behavior or mood
Call your healthcare provider right away

Karatteristiċi tal-prodott

CITALOPRAM- CITALOPRAM SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
CITALOPRAM ORAL SOLUTION, USP
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
ORAL SOLUTION 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_)
DESCRIPTION
Citalopram Oral Solution, USP 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
hydrobromide is a
racemic bicyclic phthalane derivative designated
(±)-1-(3-dimethylaminopropyl)-1-(4-
fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the
following structural
formula:
The molecular formula is C
H
BrFN O and its molecular weight is 405.30.
20
22
2
Citalopram hydrobromide, USP occurs as a fine, white to off-white
powder. Citalopram
hydrobromide is sparingly so