ESCITALOPRAM tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Hikma Pharmaceutical

INN (الاسم الدولي):

ESCITALOPRAM OXALATE

تركيب:

ESCITALOPRAM 5 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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. 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 anxiety and worry (apprehensive expectation) that is persist

ملخص المنتج:

Escitalopram Oxalate Tablets USP, 5 mg  are supplied as white, round, film-coated tablets, non scored Imprinted with "W28." 5 mg Tablets: Bottle of 100          Escitalopram Oxalate Tablets USP, 10 mg are supplied as white, round, scored, film-coated tablets Imprinted with "W" on one side of the bisect and "29" on the other side. Bottle of 100 Bottle of 500  Escitalopram Oxalate Tablets USP, 20 mg are supplied as white, round, scored, film-coated tablets imprinted with "W" on one side of the bisect and "30" on the other side. Bottle of 100 Bottle of 500              Storage and Handling Store at 20°-25° C (68°-77° F) - Excursions permitted to 15° to 30° C ( 59° to 86° F)

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

ESCITALOPRAM- ESCITALOPRAM TABLET, FILM COATED
Hikma Pharmaceutical
----------
MEDICATION GUIDE
Medication Guide
Escitalopram 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.
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 a

خصائص المنتج

ESCITALOPRAM- ESCITALOPRAM TABLET, FILM COATED
HIKMA PHARMACEUTICAL
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESCITALOPRAM TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESCITALOPRAM
TABLETS, USP.
ESCITALOPRAM TABLETS, USP 5 MG, 10 MG, AND 20 MG 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. ESCITALOPRAM
OXALATE IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS LESS THAN 12
YEARS OF AGE (5.1)
INDICATIONS AND USAGE
----------------------------------------------------------------------------------------------------------------------------------------
--------------- (1)
Escitalopram Tablets, USP are a selective serotonin reuptake inhibitor
(SSRI) indicated for: (1)
Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in
adults and adolescents aged 12-17 years
(1.1)
Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2)
DOSAGE AND ADMINISTRATION
----------------------------------------------------------------------------------------------------------------------------------------
----- (2)
Escitalopram oxalate should generally be administered once daily,
morning or evening with or without food (2.1, 2.2). (2)
Indication (2)
Recommended Dose (2)
MDD (2.1) (2)
Adolescents (2.1) (2)
Initial: 10 mg once daily (2)
Recommended: 10 mg once daily (2)
Maximum: 20 mg once daily (2)
Adults (2.1) (2)
Initial: 10 mg once daily (2)
Recommended: 10 mg once daily (2)
Maximum: 20 mg once daily (2)
GAD (2.2) (2)
Adults (2.2) (2)
Initial: 10 mg once daily (2)
Recommended: 10 mg once daily (2)
No additional benefits seen at 20 mg/day dose (2.1).
10 mg/day is the recommended dose for most elderly patients and
patients with hepatic im