ESCITALOPRAM solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Macleods Pharmaceuticals Limited

INN (International Name):

ESCITALOPRAM OXALATE

Sammensætning:

ESCITALOPRAM 5 mg in 5 mL

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Escitalopram oral solution 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. Additional pediatric use information is approved for AbbVie Inc.’s LEXAPRO (escitalopram) tablets and LEXAPRO (escitalopram) oral solution. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. 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 se

Produkt oversigt:

How Supplied Escitalopram Oral Solution 5 mg/5 mL, peppermint flavor (240 mL) NDC 33342- 053-28 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59°  to 86°F). [See USP Controlled Room Temperature.]

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

ESCITALOPRAM - ESCITALOPRAM SOLUTION
Macleods Pharmaceuticals Limited
----------
MEDICATION GUIDE
Escitalopram Oral Solution
(ES-sye-TAL-oh-pram)
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.
o 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?
o 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.
o 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.
o 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:
o attempts to commit suicide o acting on dangerous impulses
o acting aggressive, being angry or violent o thoughts about suicide
or dying
o new or worse depression o new or worsening anxiety
o panic attacks o feeling very agitated or restless
o new or worse irritability o trouble sleeping
o an extreme increase in activity or talking (mania) o other unusual
changes in behavior or mood
What is Escitalopram Oral Solution?
Escitalopram Oral Solution is a prescription medicine used to treat:
• a certain type of d

Produktets egenskaber

ESCITALOPRAM - ESCITALOPRAM SOLUTION
MACLEODS PHARMACEUTICALS LIMITED
----------
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, USP
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 ORAL
SOLUTION 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 5/2023
with Other MAOIs such as Linezolid
or Methylene Blue (2.7) - Removed
Warnings and Precautions
(5.2, 5.7) 8/2023
INDICATIONS AND USAGE
Escitalopram oral solution 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 (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
• No additional benefits were seen at 20 mg once daily (2.1)
• Administer once daily, morning or evening, with or without food
(2.3)
• Elderly patients: recommended dosage is 10 mg once daily (2.4)
• Hepatic impairment: recommended dosage is 10 mg once daily (2.4,