ESCITALOPRAM OXALATE - escitalopram oxalate solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Citron Pharma LLC

Designación común internacional (DCI):

ESCITALOPRAM OXALATE

Composición:

ESCITALOPRAM 5 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Escitalopram oral solution USP 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 oral solution USP is 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) t

Resumen del producto:

Escitalopram Oral Solution USP 5 mg/5 mL is a clear, colorless peppermint flavored liquid.         240 mL Bottle                         NDC 57237-095-24 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].

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

ESCITALOPRAM OXALATE - ESCITALOPRAM OXALATE SOLUTION
Citron Pharma LLC
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MEDICATION GUIDE
Escitalopram Oral Solution USP
(es'' sye tal' oh pram)
Read the Medication Guide that comes with escitalopram oral solution
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 oral solution?
Escitalopram oral solution and other antidepressant medicines may
cause serious side effects, including:
1. Suicidal thoughts or actions:
•
Escitalopram oral solution 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 oral
solution 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 un

Ficha técnica

ESCITALOPRAM OXALATE - ESCITALOPRAM OXALATE SOLUTION
CITRON PHARMA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESCITALOPRAM OXALATE SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR ESCITALOPRAM ORAL SOLUTION USP.
ESCITALOPRAM ORAL SOLUTION USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
WARNINGS: 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).
RECENT MAJOR CHANGES
Warnings and Precautions (5.9) 07/2014
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 oral solution should generally be administered once
daily, morning or evening with or without food (2.1, 2.2).
Indication
Recommended Dose
MDD (2.1)
Adolescents (2.1)
Initial: 10 mg once daily
Recommended: 10 mg once daily
Maximum: 20 mg once daily
Adults (2.1)
Initial: 10 mg once daily
Recommended: 10 mg once daily
Maximum: 20 mg once daily
GAD (2.2)
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 Oral Solution: A gradual dose reduction is
recommended (2.4).
DOSAGE FORMS AND STRENGTHS
Oral Solution: 5 mg/5 mL (3.2)
CONTRAINDICATIONS
Seroto