ESCITALOPRAM OXALATE- escitalopram tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

ESCITALOPRAM OXALATE

Composition:

ESCITALOPRAM 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Escitalopram tablets are 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 tablets are indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [see Clinical Studies (14.2) ]. Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at le

Product summary:

Escitalopram Tablets, USP are available containing escitalopram oxalate, USP equivalent to 10 mg or 20 mg of escitalopram base. The 10 mg tablets are white to off-white, film-coated, round, scored tablets debossed with M on one side of the tablet and EC above the score and 10 below the score on the other side. They are available as follows: NDC 54868-6375-0 bottles of 30 tablets NDC 54868-6375-1 bottles of 90 tablets The 20 mg tablets are white to off-white, film-coated, round, scored tablets debossed with M on one side of the tablet and EC above the score and 20 below the score on the other side. They are available as follows: NDC 54868-6376-0 bottles of 30 tablets NDC 54868-6376-1 bottles of 90 tablets Storage and Handling: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

New Drug Application

Patient Information leaflet

ESCITALOPRAM OXALATE - ESCITALOPRAM TABLET, FILM COATED
Physicians Total Care, Inc.
----------
MEDICATION GUIDE
ESCITALOPRAM TABLETS, USP
(es″ sye tal′ oh)
5 mg, 10 mg and 20 mg
Read the Medication Guide that comes with escitalopram tablets 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 tablets?
Escitalopram tablets and other antidepressant medicines may cause
serious side effects, including:
1.
Suicidal thoughts or actions:
•
Escitalopram tablets 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 tablets are
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
•
other unusual

Summary of Product characteristics

ESCITALOPRAM OXALATE - ESCITALOPRAM TABLET, FILM COATED
PHYSICIANS TOTAL CARE, 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, USP
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
TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS LESS THAN 12
YEARS OF AGE (5.1).
INDICATIONS AND USAGE
Escitalopram tablets are 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 tablets 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 Tablets: A gradual dose reduction is
recommended (2.4).
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg (scored) and 20 mg (scored) (3.1)
CONTRAINDICATIONS
Monoamine Oxidase Inhibitors: Do not use with an MAOI or within 14
da