ESCITALOPRAM- escitalopram 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:

STI Pharma LLC

INN (International Name):

ESCITALOPRAM OXALATE

Composition:

ESCITALOPRAM 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 anxiety and worry (apprehensive expectation) that is persistent

Product summary:

Escitalopram tablets, USP are available as follows: 5 mg – Each white to off-white, round, film coated tablet imprinted with S 5 contains escitalopram oxalate, USP equivalent to 5 mg escitalopram. Tablets are supplied in bottles of 100 (NDC 54879-009-01) with a child-resistant closure 10 mg – Each white to off-white, round, film coated tablet imprinted with S 10 and a bisect on the other side contains escitalopram oxalate, USP equivalent to 10 mg escitalopram. Tablets are supplied in bottles of 100 (NDC 54879-010-01) and 500 (NDC 54879-010-05) with a child-resistant closure 20 mg – Each white to off-white, round, film coated tablet imprinted with S 20 and a bisect on the other side contains escitalopram oxalate, USP equivalent to 20 mg escitalopram. Tablets are supplied in bottles of 100 (NDC 54879-011-01) and 500 (NDC 54879-011-05) with a child-resistant closure To report SUSPECTED ADVERSE REACTIONS, contact STI Pharma, LLC at 1-888-301-9680 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C with excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Keep container tightly closed. PHARMACIST: Dispense a Medication guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESCITALOPRAM- ESCITALOPRAM TABLET, FILM COATED
STI Pharma LLC
----------
17.2 FDA-APPROVED MEDICATION GUIDE
MEDICATION GUIDE
ESCITALOPRAM TABLETS, USP
(es" sye tal' oh pram)
5 mg, 10 mg and 20 mg
Read the Medication Guide that comes with Escitalopram tablets, USP
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, USP tablets?
Escitalopram tablets, USP tablets and other antidepressant medicines
may cause serious side effects,
including:
1. Suicidal thoughts or actions:
•
Escitalopram tablets, USP 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,
USP 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

Summary of Product characteristics

ESCITALOPRAM- ESCITALOPRAM TABLET, FILM COATED
STI PHARMA LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
ESCITALOPRAM TABLETS, USP
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESCITALOPRAM TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESCITALOPRAM
TABLETS, USP.
ESCITALOPRAM TABLET, 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
TABLETS, USP ARE 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 tablets, USP are 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
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 tablets, USP: 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
psychiatric disord