CITALOPRAM- citalopram tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

A-S Medication Solutions

ИНН (Международная Имя):

CITALOPRAM HYDROBROMIDE

состав:

CITALOPRAM 40 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Citalopram tablets, USP are indicated for the treatment of depression. The efficacy of citalopram 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 tablets, USP in hospitalized depressed patients has not been adequately studied. The efficacy

Обзор продуктов:

Product: 50090-0893 NDC: 50090-0893-0 30 TABLET in a BOTTLE NDC: 50090-0893-1 100 TABLET in a BOTTLE NDC: 50090-0893-2 90 TABLET in a BOTTLE

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

CITALOPRAM- CITALOPRAM TABLET
A-S Medication Solutions
----------
MEDICATION GUIDE
Citalopram Tablets, USP
(sih-TAL-oh-pram)
Read the Medication Guide that comes with citalopram 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
tablets?
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 if you have any of the
fol

Характеристики продукта

CITALOPRAM- CITALOPRAM TABLET
A-S MEDICATION SOLUTIONS
----------
CITALOPRAM TABLETS, USP
RX ONLY
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 tablets are not approved for use in pediatric
patients (see WARNINGS:
Clinical Worsening and Suicide Risk, PRECAUTIONS:Information for
Patients and
PRECAUTIONS:Pediatric Use).
DESCRIPTION
Citalopram HBr is an orally administered selective serotonin reuptake
inhibitor (SSRI) with a chemical
structure unrelated to that of other SSRIs or of tricyclic,
tetracyclic, or other available antidepressant
agents. Citalopram HBr 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 405.35.
Citalopram hydrobromide, USP occurs as a fine, white to off-white
powder. Citalopram HBr is
sparingly soluble in water and soluble in ethanol.
Citalopram hydrobromide