ESCITALOPRAM- escitalopram oxalate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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) ].  Generaliz

Product summary:

Escitalopram tablets, USP 5 mg are white, round, biconvex, film-coated tablets, debossed with ‘B2’ on one side and ‘C’ on the other side. Bottle of 100      NDC 68001-195-00 Escitalopram tablets, USP 10 mg  are white, oval shaped, biconvex, film-coated tablets, with scoreline on one side, debossed with ‘B’ on left side of scoreline and ‘3’ on right side of scoreline and with ‘C’ on the other side. Bottle of 100      NDC 68001-196-00 Bottle of 500      NDC 68001-196-03 Escitalopram tablets,  USP 20 mg  are white, oval shaped, biconvex, film-coated tablets, with scoreline on one side, debossed with ‘B4’ on left side of scoreline and ‘C’ on right side of the scoreline and plain on the other side. Bottle of 100      NDC 68001-197-00 Bottle of 500      NDC 68001-197-03 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]. Dispense in a well-closed container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESCITALOPRAM- ESCITALOPRAM OXALATE TABLET, FILM COATED
REMEDYREPACK 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 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

Summary of Product characteristics

ESCITALOPRAM- ESCITALOPRAM OXALATE TABLET, FILM COATED
REMEDYREPACK 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 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:
Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in
adults and adolescents aged 12 -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 treat
psychia