ESCITALOPRAM tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

NuCare Pharmaceuticals,Inc.

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Escitalopram tablet, is 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 tablet, is indicated for the acute

Toote kokkuvõte:

White to off-white, round, biconvex, film -coated tablets, debossed with 10 on one side and break line on other side. 20 mg Tablets: NDC 68071-4985-3 BOTTLES OF 30 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature].

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

ESCITALOPRAM- ESCITALOPRAM TABLET, FILM COATED
NuCare Pharmaceuticals,Inc.
----------
17.2 FDA-APPROVED MEDICATION GUIDE
Medication Guide
Escitalopram Tablets
(ES-sye-TAL-oh-pram)
Read the Medication Guide that comes with escitalopram tablets 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
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 tablet 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

Toote omadused

ESCITALOPRAM- ESCITALOPRAM TABLET, FILM COATED
NUCARE PHARMACEUTICALS,INC.
----------
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. ESCITALOPRAM OXALATE IS NOT APPROVED FOR USE IN
PEDIATRIC
PATIENTS LESS THAN 12 YEARS OF AGE ( 5.1).
INDICATIONS AND USAGE
Escitalopram oxalate is a selective serotonin reuptake inhibitor
(SSRI) indicated for:
Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in
adults and adolescents aged
12 to 17 years ( 1.1)
Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2)
DOSAGE AND ADMINISTRATION
Escitalopram tablets should generally be administered once daily,
morning or evening with or without food
( 2.1, 2.2).
Indication
Recommended Dose
MDD in Adolescents ( 2.1)
Initial: 10 mg once daily
Recommended: 10 mg once daily
Maximum: 20 mg once daily
MDD in Adults ( 2.1)
Initial: 10 mg once daily
Recommended: 10 mg once daily
Maximum: 20 mg once daily
GAD in Adults ( 2.2)
Initial: 10 mg once daily
Recommended: 10 mg once daily
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 impairment (
2.3).
No dosage adjustment for patients with mild or moderate renal
impairment. Use caution in patients
with severe renal impairment ( 2.3).
Discontinuing escitalopram tablets: A gradual dose reduction is
recommended ( 2.4).
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg (scored) and 20 mg (scored) ( 3.1)
CONTRAINDICATIONS
Serotonin Syndrome and MAOIs: Do not use MAOIs intended to