LEXAPRO- 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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

ESCITALOPRAM OXALATE

Composition:

ESCITALOPRAM 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lexapro (escitalopram) 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. Lexapro 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 i

Product summary:

      Tablets 10 mg Tablets:         NDC # 55289-768-30 30 Tablets White to off-white, round, scored, film-coated. Imprint on scored side with "F" on the left side and "L" on the right side. Imprint on the non-scored side with "10". Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15 to 30°C (59° to 86°F).

Authorization status:

New Drug Application

Patient Information leaflet

LEXAPRO- escitalopram oxalate tablet, film coated
PD-Rx Pharmaceuticals, Inc.
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Medication Guide
Lexapro® (leks-a-pro)
(escitalopram)
Tablets/Oral Solution
Read the Medication Guide that comes with Lexapro 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 Lexapro?
Lexapro and other antidepressant medicines may cause serious side
effects, including:
1. Suicidal thoughts or actions:
•
Lexapro 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 Lexapro 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 healthcare provider right away if you h

Summary of Product characteristics

LEXAPRO- ESCITALOPRAM OXALATE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEXAPRO® SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEXAPRO®.
LEXAPRO® (ESCITALOPRAM) TABLETS, FOR ORAL USEINITIAL U.S. APPROVAL:
2002
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_ SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN PEDIATRIC AND
YOUNG ADULT PATIENTS
TAKING ANTIDEPRESSANTS. CLOSELY MONITOR ALL ANTIDEPRESSANT-TREATED
PATIENTS FOR CLINICAL
WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS (5.1).
LEXAPRO IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS LESS THAN 12 YEARS OF AGE
(8.4).
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.11) 09/2021
INDICATIONS AND USAGE
Lexapro 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
Lexapro 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 Lexapro: A gradual dose reduction is recommended ( 2.4).
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg (scored) and 20 mg (scored)
Oral solution: 1 mg per mL (no