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:

St. Mary's Medical Park Pharmacy

INN (International Name):

ESCITALOPRAM OXALATE

Composition:

ESCITALOPRAM 20 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 i

Product summary:

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. NDC: 60760-197-30 BOTTLE OF 30 60760-197-90 BOTTLE OF 90 Storage and Handling Store at 20˚C -25˚C (68˚F -77˚F); excursions permitted to 15˚C -30˚C (59˚F -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
St. Mary's Medical Park Pharmacy
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17.2 FDA-APPROVED MEDICATION GUIDE
Medication Guide
Escitalopram Tablets, USP
Read the Medication Guide that comes with escitalopram 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?
Escitalopram and other antidepressant medicines may cause serious side
effects, including:
1. Suicidal thoughts or actions:
● Escitalopram 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 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 unusual changes in behavior or mood
Call your hea

Summary of Product characteristics

ESCITALOPRAM- ESCITALOPRAM OXALATE TABLET, FILM COATED
ST. MARY'S MEDICAL PARK PHARMACY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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 TABLETS, USP
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).
RECENT MAJOR CHANGES
Warnings and Precautions (5.9) 07/2014
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, USP 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 : 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