ESCITALOPRAM OXALATE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Proficient Rx LP

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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. Escitalopram tablets are indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [ see   Clinical   Studies   ( 14.2)

Rezumat produs:

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 71205-313-30 Bottles of 60                                          NDC 71205-313-60 Bottles of 90                                          NDC 71205-313-90 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].

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

ESCITALOPRAM OXALATE- ESCITALOPRAM OXALATE TABLET
Proficient Rx LP
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MEDICATION GUIDE
Escitalopram (EE sye TAL o pram) Tablets, USP
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 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 you

Caracteristicilor produsului

ESCITALOPRAM OXALATE- ESCITALOPRAM OXALATE TABLET
PROFICIENT RX LP
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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 USP, 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
TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS LESS THAN 12
YEARS OF AGE (5.1).
INDICATIONS AND USAGE
ESCITALOPRAM IS A SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRI)
INDICATED FOR:
•
•
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
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
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)
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).
Tablets: 5 mg, 10 mg (scored) and 20 mg (scored) ( 3.1)
Serotonin Syndrome and MAOIs: