ESCITALOPRAM OXALATE- escitalopram oxalate solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Camber Pharmaceuticals, Inc.

INN (International Name):

ESCITALOPRAM OXALATE

Composition:

ESCITALOPRAM 5 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Escitalopram oral solution is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see Clinical Studies ( 14.1)]. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. Escitalopram oral solution is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [see Clinical Studies ( 14.2)]. Generalized Anxiety Disorder

Product summary:

Oral Solution Escitalopram oral solution, USP 5 mg/5 mL is a clear, colorless to pale yellow peppermint flavored liquid. Bottles of 240 mL with Induction Sealing FSE Wad (NDC 31722-569-24) Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESCITALOPRAM OXALATE - ESCITALOPRAM OXALATE SOLUTION
Camber Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Escitalopram Oral Solution, USP
(es'' sye tal' oh pram)
Read the Medication Guide that comes with escitalopram oral solution
before you start taking it and each
time you get a refill. There may be new information. This Medication
Guide does not take the place of
talking to your healthcare provider about your medical condition or
treatment. Talk with your healthcare
provider if there is something you do not understand or want to learn
more about.
What is the most important information I should know about
escitalopram oral solution?
Escitalopram oral solution and other antidepressant medicines may
cause serious side effects, including:
1. Suicidal thoughts or actions:
• Escitalopram oral solution and other antidepressant medicines may
increase suicidal thoughts or actions in
some children, teenagers, or young adults within the first few months
of treatment or when the dose is
changed.
• Depression or other serious mental illnesses are the most
important causes of suicidal thoughts or actions.
• Watch for these changes and call your healthcare provider right
away if you notice:
• New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
• Pay particular attention to such changes when escitalopram oral
solution is started or when the dose is
changed.
Keep all follow-up visits with your healthcare provider and call
between visits if you are worried about
symptoms.
Call your healthcare provider right away if you have any of the
following symptoms, or call 911 if an
emergency, especially if they are new, worse, or worry you:
• attempts to commit suicide
• acting on dangerous impulses
• acting aggressive or violent
• thoughts about suicide or dying
• new or worse depression
• new or worse anxiety or panic attacks
• feeling agitated, restless, angry or irritable
• trouble sleeping
• an increase in activity or talking more than what is normal for
you

Summary of Product characteristics

ESCITALOPRAM OXALATE - ESCITALOPRAM OXALATE SOLUTION
CAMBER PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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 ORAL
SOLUTION IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS LESS THAN 12
YEARS OF AGE ( 8.4).
INDICATIONS AND USAGE
Escitalopram oral solution is a selective serotonin reuptake inhibitor
(SSRI) indicated for:
• Acute and Maintenance Treatment of Major Depressive Disorder (MDD)
in adults and adolescents aged
12 to 17 years ( 1.1)
• Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (
1.2)
DOSAGE AND ADMINISTRATION
Escitalopram oral solution should generally be administered once
daily, morning or evening with or without
food ( 2.1, 2.2).
Indication
Recommended Dose
MDD in Adolescents ( 2.1)
Initial: 10 mg once daily
Recommended: 10 mg once daily
Maximum: 20 mg once daily
MDD in Adults ( 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
• No additional benefits seen at 20 mg/day dose ( 2.1).
• 10 mg/day is the recommended dose for most elderly patients and
patients with hepatic impairment (
2.3).
• No dosage adjustment for patients with mild or moderate renal
impairment. Use caution in patients with
severe renal impairment ( 2.3).
• Discontinuing Escitalopram Oral Solution: A gradual dose reduction
is recommended ( 2.4).
DOS