ESCITALOPRAM OXALATE- escitalopram tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Aphena Pharma Solutions - Tennessee, LLC

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 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) that is persistent for at least s

Tuoteyhteenveto:

Escitalopram Tablets, USP 5 mg, 10 mg and 20 mg are supplied as follows: 5 mg Tablets: White, film coated, round, biconvex tablets debossed with IG on one side and 249 on other. Bottle of 30 NDC # 76282-249-30 Bottle of 90 NDC # 76282-249-90 Bottle of 100 NDC # 76282-249-01 Bottle of 500 NDC # 76282-249-05 Bottle of 1000 NDC # 76282-249-10 10 mg Tablets: White, film coated, round, biconvex tablets debossed with I on left side and G on right side of bisect and 250 on other. Bottle of 30 NDC # 76282-250-30 Bottle of 90 NDC # 76282-250-90 Bottle of 100 NDC # 76282-250-01 Bottle of 500 NDC # 76282-250-05 Bottle of 1000 NDC # 76282-250-10 20 mg Tablets: White, film coated, round, biconvex tablets debossed with I on left side and G on right side of bisect and 251 on other. Bottle of 30 NDC # 76282-251-30 Bottle of 90 NDC # 76282-251-90 Bottle of 100 NDC # 76282-251-01 Bottle of 500 NDC # 76282-251-05 Bottle of 1000 NDC # 76282-251-10 Storage and Handling: Store at 20°C to 25°C (68° F to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

ESCITALOPRAM OXALATE - ESCITALOPRAM TABLET, FILM COATED
Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
ESCITALOPRAM TABLETS, USP
(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 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 ch

Valmisteyhteenveto

ESCITALOPRAM OXALATE - ESCITALOPRAM TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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 IS 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:
• 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