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:

Pharmaceutical Associates, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Escitalopram Oxalate 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 Oxalate is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [ see Clinical Studies (14.2) ]. Generalize

Product summary:

NDC 0121-0852-10: 10 mL unit dose cup NDC 0121-0852-40: Case contains 40 unit dose cups of 10 mL (0121-0852-10) packaged in 4 trays of 10 unit dose cups each. 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
Pharmaceutical Associates, Inc.
----------
MEDICATION GUIDE
Escitalopram Oxalate (ES-sye-TAL-oh-pram OX-a-late)
Oral Solution
Read the Medication Guide that comes with Escitalopram Oxalate 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 Oxalate?
Escitalopram Oxalate and other antidepressant medicines may cause
serious side effects, including:
1.
Suicidal thoughts or actions:
•
Escitalopram Oxalate 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 oxalate 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
PHARMACEUTICAL ASSOCIATES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESCITALOPRAM OXALATE
ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR ESCITALOPRAM
OXALATE ORAL SOLUTION.
ESCITALOPRAM OXALATE ORAL SOLUTION
INITIAL U.S. APPROVAL: 2002
WARNING: _SUICIDALITY AND ANTIDEPRESSANT DRUGS_
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG
ADULTS TAKING ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER (MDD) AND
OTHER
PSYCHIATRIC DISORDERS. ESCITALOPRAM OXALATE IS NOT APPROVED FOR USE IN
PEDIATRIC
PATIENTS LESS THAN 12 YEARS OF AGE ( 5.1).
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.2) 01/2017
INDICATIONS AND USAGE
Escitalopram Oxalate is a selective serotonin reuptake inhibitor
(SSRI) indicated for:
Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in
adults and adolescents aged
12-17 years ( 1.1)
Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2)
DOSAGE AND ADMINISTRATION
Escitalopram Oxalate should generally be administered once daily,
morning or evening with or without food
( 2.1, 2.2).
INDICATION
RECOMMENDED DOSE
MDD ( 2.1)
Adolescents ( 2.1)
Initial: 10 mg once daily
Recommended: 10 mg once daily
Maximum: 20 mg once daily
Adults ( 2.1)
Initial: 10 mg once daily
Recommended: 10 mg once daily
Maximum: 20 mg once daily
GAD ( 2.2)
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 Oxalate: A gradual dose reduction is
recommended ( 2.4).
DOSAGE FORMS AND STRENGTHS
Oral solution: 1 mg per mL ( 3.2)