ESCITALOPRAM OXALATE- escitalopram tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Exelan Pharmaceuticals Inc.

INN (nemzetközi neve):

ESCITALOPRAM OXALATE

Összetétel:

ESCITALOPRAM 5 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 inactive ingredie

Termék összefoglaló:

Escitalopram Tablets, USP 5 mg, 10 mg and 20 mg are supplied as follows: 5 mg Tablets: White, film coated, round, biconvex tablets debossed with IG on one side and 249 on other. Bottle of 30 NDC # 76282-249-30 Bottle of 90 NDC # 76282-249-90 Bottle of 100 NDC # 76282-249-01 Bottle of 500 NDC # 76282-249-05 Bottle of 1000 NDC # 76282-249-10 10 mg Tablets: White, film coated, round, biconvex tablets debossed with I on left side and G on right side of bisect and 250 on other. Bottle of 30 NDC # 76282-250-30 Bottle of 90 NDC # 76282-250-90 Bottle of 100 NDC # 76282-250-01 Bottle of 500 NDC # 76282-250-05 Bottle of 1000 NDC # 76282-250-10 20 mg Tablets: White, film coated, round, biconvex tablets debossed with I on left side and G on right side of bisect and 251 on other. Bottle of 30 NDC # 76282-251-30 Bottle of 90 NDC # 76282-251-90 Bottle of 100 NDC # 76282-251-01 Bottle of 500 NDC # 76282-251-05 Bottle of 1000 NDC # 76282-251-10 Storage and Handling Store at 20°C to 25°C (68° F to 77°F). [See USP Controlled Room Temperature].

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

Exelan Pharmaceuticals Inc.
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MEDICATION GUIDE
Escitalopram tablets
What is the most important information I should know about
escitalopram? escitalopram may cause
serious side effects, including:
•
Increased risk of suicidal thoughts or actions. escitalopram 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 escitalopram?
escitalopram is a prescription medicine used to treat:
•
a certain type of depression called Major Depressive Disorder (MDD) in
adults and children 12
years of age and older
•
Gener

Termékjellemzők

ESCITALOPRAM OXALATE - ESCITALOPRAM TABLET, FILM COATED
EXELAN PHARMACEUTICALS INC.
----------
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 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)
8/2023
INDICATIONS AND USAGE
Escitalopram is a selective serotonin reuptake inhibitor (SSRI)
indicated for:
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 food (2.3)
Elde