ESCITALOPRAM- escitslopram tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

ESCITALOPRAM OXALATE

Composition:

ESCITALOPRAM 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Escitalopram tablets USP are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to17 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 USP 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 fo

Product summary:

Each film coated round tablet contains escitalopram oxalate equivalent to the labeled amount of escitalopram as follows: • 5 mg Tablets: White to off-white, round, film coated tablets, debossed with "LU" on one side and "W21" on the other side                               Blistercards of 30                                NDC 0615-7953-39 • 10 mg Tablets: White to off-white, round, film coated tablets, debossed with 'L' and 'U' either side of the scoreline on one side and 'W22' on the other side.                               Blistercards of 30                              NDC 0615-7954-39                               Blistercards of 15                              NDC 0615-7954-05                               Unit-dose  Boxes of 30                      NDC 0615-7954-30 • 20 mg Tablets: White to off-white, round, film coated tablets, debossed with 'L' and 'U' either side of the scoreline on one side and 'W23' on the other side.                               Blistercards of 30                             NDC 0615-7955-39                               Blistercards of 15                             NDC 0615-7955-05 Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESCITALOPRAM- ESCITSLOPRAM TABLET
NCS HealthCare of KY, Inc dba Vangard Labs
----------
•
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 tablet 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
•
other unusual changes in behavior or mood
Call your healthcare provider right away if you have any of the
following symptoms, or call 911 if an
emergency. Escitalopram tablets may be associated with these serious
side effects:
2. Serotonin Syndrome. This condition can be life-threatening and may
include:
•
agitation, hallucinations, coma or other changes in mental status
•
coordination problems or muscle twitching (overactive reflexes)
•
racing heartbeat, high or low blood pressure
•
sweating or fever
•
nausea, vomiting, or diarrhea
•
muscle rigidity
3. Severe allergic reactions:
•
trouble breathing
•
swelling of the face, tongue, eyes or mouth
•
rash, itchy welts (hives) or blis

Summary of Product characteristics

ESCITALOPRAM- ESCITSLOPRAM TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESCITALOPRAM TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESCITALOPRAM TABLETS
USP.
ESCITALOPRAM TABLETS USP, FOR ORAL USE
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
TABLET USP IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS LESS THAN 12
YEARS OF AGE (5.1).
RECENT MAJOR CHANGES
Warnings and Precautions (5.9) 07/2014
INDICATIONS AND USAGE
Escitalopram tablet USP 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 tablets USP 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 USP: A gradual dose reduction is
recommended (2.4).
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg (scored) and 20 mg (scored) (3.1)
C