LEXAPRO- escitalopram tablet, film coated LEXAPRO- escitalopram solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Allergan, Inc.

INN (International Name):

ESCITALOPRAM OXALATE

Composition:

ESCITALOPRAM 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lexapro is indicated for the treatment of: • major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. • generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older. Lexapro is contraindicated in patients: - taking MAOIs with Lexapro or within 14 days of stopping treatment with Lexapro because of an increased risk of serotonin syndrome. The use of Lexapro within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration ( 2.7 ) and Warnings and Precautions ( 5.2 )] . Starting Lexapro in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration ( 2.6 ) and  Warnings and Precautions ( 5.2 ) ]. - taking pimozide [see Drug Interactions ( 7 ) ] .   - with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients in Lexapro.

Product summary:

How Supplied Tablets 5 mg Tablets: Bottle of 100                     NDC # 0456-2005-01 White to off-white, round, non-scored, film-coated. Imprint "FL" on one side of the tablet and "5" on the other side. 10 mg Tablets: Bottle of 100                     NDC # 0456-2010-01 10 x 10 Unit Dose             NDC # 0456-2010-63 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". 20 mg Tablets: Bottle of 100                     NDC # 0456-2020-01 10 x 10 Unit Dose             NDC # 0456-2020-63 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 "20". Oral Solution 5 mg/5 mL, peppermint flavor (240 mL) NDC # 0456-2101-08. The oral solution is not currently being marketed. 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 SOLUTION
Allergan, Inc.
----------
MEDICATION GUIDE
Lexapro® (leks-a-pro)
(escitalopram)
tablets
oral solution
What is the most important information I should know about Lexapro?
Lexapro may cause serious side effects, including:
•
Increased risk of suicidal thoughts or actions. Lexapro and other
antidepressant
medicines increase the risk of suicidal thoughts and actions in people
24 years of age
and younger, especially within the first few months of treatment or
when the dose is
changed.
○ Depression or other mental illnesses are the most important causes
of suicidal
thoughts or actions.
How can I watch for and try to prevent suicidal thoughts and actions?
○ Pay close attention to any changes, especially sudden changes in
mood, behavior,
thoughts, or feelings, or if you or your child develop suicidal
thoughts or actions. This
is very important when an antidepressant medicine is started or when
the dose is
changed.
○ Call your healthcare provider right away to report new or sudden
changes in mood,
behavior, thoughts, or feelings or if you or your child develop
suicidal thoughts or
actions.
○ Keep all follow-up visits with your healthcare provider as
scheduled and call your
healthcare provider between visits if you are worried about symptoms.
Call your healthcare provider or get emergency medical help right away
if you or your child
have any of the following symptoms, especially if they are new, worse,
or worry you:
•
attempts to commit suicide
•
acting on dangerous impulses
•
acting aggressive, being angry or
violent
•
thoughts about suicide or dying
•
new or worse depression
•
new or worsening anxiety
•
panic attacks
•
feeling very agitated or restless
•
new or worse irritability
•
trouble sleeping
•
an extreme increase in activity or
talking (mania)
•
other unusual changes in behavior or
mood
What is Lexapro?
Lexapro is a prescription medicine used to treat:
•
a certain type of depression called Major Depressive Disorder (MDD) in
adults and
children 12

Summary of Product characteristics

LEXAPRO- ESCITALOPRAM TABLET, FILM COATED
LEXAPRO- ESCITALOPRAM SOLUTION
ALLERGAN, 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 USE
LEXAPRO (ESCITALOPRAM) ORAL SOLUTION
INITIAL 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 7 YEARS OF AGE (8.4).
RECENT MAJOR CHANGES
Indications (1)
5/2023
Dosage and Administration (2.2, 2.3, 2.5)
Dosage and Administration, Use of Lexapro with Other MAOIs such as
Linezolid or Methylene Blue
(2.7) - Removed
5/2023
5/2023
Warnings and Precautions (5.2, 5.7)
8/2023
INDICATIONS AND USAGE
Lexapro is a selective serotonin reuptake inhibitor (SSRI) indicated
for the:
treatment of major depressive disorder (MDD) in adults and pediatric
patients 12 years of age and
older (1)
treatment of generalized anxiety disorder (GAD) in adults and
pediatric patients 7 years and older (1)
DOSAGE AND ADMINISTRATION
Indication and Population
Recommended Dosage
MDD in Adults
(2.1)
Initial: 10 mg once daily
Recommended: 10 mg once daily
Maximum: 20 mg once daily
MDD in Pediatric Patients 12 years and older (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
Maximum: 20 mg once daily
GAD in Pediatric Patients 7 years and older (2.2)
Initial: 10 mg once daily
Recommended: 10 mg once daily
Maximum: 20 mg once daily
No additional benefits were seen at 20 mg once daily (2.1)
Administer once daily, morning or evening, with or without fo