ESCITALOPRAM OXALATE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Direct Rx

INN (Rahvusvaheline Nimetus):

ESCITALOPRAM OXALATE

Koostis:

ESCITALOPRAM 10 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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

Toote kokkuvõte:

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. Bottles of 30 NDC 13668-135-30 Bottles of 100 NDC 13668-135-01 Bottles of 500 NDC 13668-135-05 Bottles of 1000 NDC 13668-135-10 Bottles of 4000 NDC 13668-135-40 100 Unit Dose Tablets NDC 13668-135-74 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, Bottles of 30 NDC 13668-136-30 Bottles of 100 NDC 13668-136-01 Bottles of 500 NDC 13668-136-05 Bottles of 1000 NDC 13668-136-10 Bottles of 3000 NDC 13668-136-43 100 Unit Dose Tablets NDC 13668-136-74 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. Bottles of 30 NDC 13668-137-30 Bottles of 100 NDC 13668-137-01 Bottles of 500 NDC 13668-137-05 Bottles of 1000 NDC 13668-137-10 Bottles of 2000 NDC 13668-137-20 100 Unit Dose Tablets NDC 13668-137-74 Storage and Handling Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

Direct Rx
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Revised: 3/2022
Document Id: d929b068-4c88-0c5c-e053-2995a90ab99a
34391-3
Set id: ce8be2b4-1525-4864-99c1-9e24815957dc
Version: 7
Effective Time: 20220301
Direct Rx

Toote omadused

ESCITALOPRAM OXALATE- ESCITALOPRAM OXALATE TABLET
DIRECT RX
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ESCITALOPRAM OXALATE
FULL PRESCRIBING INFORMATION
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. INDICATIONS AND USAGE
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