ESCITALOPRAM tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY)

Mevcut itibaren:

RedPharm Drug, Inc.

INN (International Adı):

ESCITALOPRAM OXALATE

Kompozisyon:

ESCITALOPRAM 20 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

1.1 Major Depressive Disorder Escitalopram tablets are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see Clinical Studies (14.1)]. 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. 1.2 Generalized Anxiety Disorder Escitalopram tablets are indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [see Clinical Studies (14.2)]. Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and

Ürün özeti:

Escitalopram Tablets USP, 5 mg are available as white to off-white, round, biconvex, unscored, film-coated tablets, debossed “5850” on one side and “Ivax hourglass logo” “5” on the other side, packaged in bottles of 100 (0093-5850-01) and 500 (0093-5850-05) tablets. Escitalopram Tablets USP, 10 mg are available as white to off-white, round, biconvex, scored, film-coated tablets, debossed “5851” on one side and “Ivax hourglass logo”, a score, and “10” on the other side, packaged in bottles of 100 (0093-5851-01) and 500 (0093-5851-05) tablets. Escitalopram Tablets USP, 20 mg are available as white to off-white, round, biconvex, scored, film-coated tablets, debossed “5852” on one side and “Ivax hourglass logo”, a score, and “20” on the other side, packaged in bottles of 100 (0093-5852-01) and 500 (0093-5852-05) tablets. Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure as required. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

ESCITALOPRAM - ESCITALOPRAM TABLET, FILM COATED
RedPharm Drug, Inc.
----------
MEDICATION GUIDE
Escitalopram (ES-sye-TAL-oh-pram) Tablets USP
Read the Medication Guide that comes with escitalopram tablets before
you start taking them 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
escitalopram tablets?
Escitalopram tablets and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
•
Escitalopram tablets 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 escitalopram tablets are
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

Ürün özellikleri

ESCITALOPRAM - ESCITALOPRAM TABLET, FILM COATED
REDPHARM DRUG, INC.
----------
ESCITALOPRAM 20MG
BOXED WARNING
WARNINGS: 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 escitalopram 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. Escitalopram is not approved for use in pediatric patients
less than 12 years of age
[see Warnings and Precautions: Clinical Worsening and Suicide Risk
(5.1), Patient Counseling
Information: Information for Patients (17.1), and Use in Specific
Populations: Pediatric Use (8.4)].
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ESCITALOPRAM TABLETS safely
and effectively. See full prescribing information for ESCITALOPRAM
TABLETS.
ESCITALOPRAM tablets, for oral use
Initial U.S. Approval: 2002
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Increased risk of suicidal thinking and behavior in children,
adolescents and young adults taking
antidepressants for major depressive disorder (MDD) and other
psychiatric disorders. Es