ESCITALOPRAM OXALATE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

DIRECT RX

INN (nemzetközi neve):

ESCITALOPRAM OXALATE

Összetétel:

ESCITALOPRAM 5 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

1.1 Major Depressive Disorder Escitalopram tablets, USP 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, USP 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 a

Termék összefoglaló:

16.1 Tablets Escitalopram tablets, USP 5 mg are white to off-white, round, biconvex, film coated tablets debossed with '135' on one side and '5' on other side. Escitalopram tablets, USP 10 mg are white to off-white, round, biconvex, film coated tablets debossed with break line on one side, separating '11' and '36' on one side, and '10' on other side. Escitalopram tablets, USP 20 mg are white to off-white, round, biconvex, film coated tablets debossed with break line on one side, separating '11' and '37' on one side, and '20' on other side. Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

ESCITALOPRAM OXALATE- ESCITALOPRAM OXALATE TABLET
DIRECT RX
----------
See FDA-approved Medication Guide
17.1 Information for Patients
Physicians are advised to discuss the following issues with patients
for whom they prescribe escitalopram
tablets.
General Information about Medication Guide
Prescribers or other health professionals should inform patients,
their families, and their caregivers about
the benefits and risks associated with treatment with escitalopram
oxalate and should counsel them in its
appropriate use. A patient Medication Guide about "Antidepressant
Medicines, Depression and other
Serious Mental Illness, and Suicidal Thoughts or Actions" is available
for escitalopram tablets. The
prescriber or health professional should instruct patients, their
families, and their caregivers to read the
Medication Guide and should assist them in understanding its contents.
Patients should be given the
opportunity to discuss the contents of the Medication Guide and to
obtain answers to any questions they
may have. The complete text of the Medication Guide is reprinted at
the end of this document.
Patients should be advised of the following issues and asked to alert
their prescriber if these occur while
taking escitalopram tablets.
Clinical Worsening and Suicide Risk
Patients, their families, and their caregivers should be encouraged to
be alert to the emergence of anxiety,
agitation, panic attacks, insomnia, irritability, hostility,
aggressiveness, impulsivity, akathisia
(psychomotor restlessness), hypomania, mania, other unusual changes in
behavior, worsening of
depression, and suicidal ideation, especially early during
antidepressant treatment and when the dose is
adjusted up or down. Families and caregivers of patients should be
advised to look for the emergence of
such symptoms on a day-to-day basis, since changes may be abrupt. Such
symptoms should be reported
to the patient's prescriber or health professional, especially if they
are severe, abrupt in onset, or were not
part of the patient's presenting sympt

Termékjellemzők

ESCITALOPRAM OXALATE- ESCITALOPRAM OXALATE TABLET
DIRECT RX
----------
ESCITALOPRAM 5MG
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 escitalopram
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. Escitalopram tablets are 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)].
1.1 Major Depressive Disorder
Escitalopram tablets, USP 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 a