ESCITALOPRAM solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lannett Company, Inc.

INN (International Name):

ESCITALOPRAM OXALATE

Composition:

ESCITALOPRAM 5 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Escitalopram 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. Escitalopram is contraindicated in patients: - taking MAOIs with escitalopram or within 14 days of stopping treatment with escitalopram because of an increased risk of serotonin syndrome. The use of escitalopram 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 escitalopram 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 inact

Product summary:

How Supplied Escitalopram Oral Solution 5 mg/5 mL, peppermint flavor (240 mL bottle) NDC# 54838-551-70 Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Lannett Company, Inc.
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Dispense with Medication Guide available at:
www.lannett.com/med-guide/escitalopram
Medication Guide
Escitalopram (es” sye tal’ oh pram)
Oral Solution
What is the most important information I should know about
Escitalopram Oral Solution?
Escitalopram oral solution may cause serious side effects, including:
•
Increased risk of suicidal thoughts or actions. Escitalopram oral
solution 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 aggressive, being angry or violent
•
new or worse depression
•
panic attacks
•
new or worse irritability
•
an extreme increase in activity or talking (mania)
•
acting on dangerous impulses
•
thoughts about suicide or dying
•
new or worsening anxiety
•
feeling very agitated or restless
•
trouble sleeping
•
other unusual changes in behavior or mood
What is Escitalopram Oral Solution?
Escitalopram oral

Summary of Product characteristics

ESCITALOPRAM- ESCITALOPRAM SOLUTION
LANNETT COMPANY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESCITALOPRAM ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ESCITALOPRAM ORAL
SOLUTION.
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).
ESCITALOPRAM 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) 5/2023
Dosage and Administration, Use of Escitalopram with Other MAOIs
such as Linezolid or Methylene Blue (2.7) - Removed 5/2023
Warnings and Precautions (5.2, 5.7) 5/2023
Warnings and Precautions, Serotonin Syndrome (5.2) 6/2023
Warnings and Precautions (5.7) 6/2023
INDICATIONS AND USAGE
Escitalopram 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.