ESCITALOPRAM OXALATE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

PD-Rx Pharmaceuticals, Inc.

INN (Algemene Internationale Benaming):

ESCITALOPRAM OXALATE

Samenstelling:

ESCITALOPRAM 10 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Product samenvatting:

How Supplied Escitalopram tablets, USP 10 mg are white to off-white, round, biconvex, film coated tablets debossed with break line on one side, separating '11' and '36' on one side, and '10' on other side. Bottles of 30 NDC 43063-761-30 Bottles of 90 NDC 43063-761-90 Bottles of 100 NDC 43063-761-01 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].

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

PD-Rx Pharmaceuticals, Inc.
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MEDICATION GUIDE
Escitalopram (EE sye TAL o pram) Tablets, USP
What is the most important information I should know about
escitalopram tablets?
Escitalopram tablets may cause serious side effects, including:
•
Increased risk of suicidal thoughts or actions.Escitalopram tablets
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 tablets?
Escitalopram tablets are prescription medicine used to treat:
• a certain type of depression called Major Depressive Disorder
(MDD) in adults and children 12 y

Productkenmerken

ESCITALOPRAM OXALATE- ESCITALOPRAM OXALATE TABLET
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESCITALOPRAM TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ESCITALOPRAM TABLETS.
ESCITALOPRAM TABLETS, FOR ORAL USE
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
TABLETS ARE 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
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 ( 2.1)
• Administer once daily, morning or eveni