LEXAPRO- escitalopram oxalate tablet

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 OXALATE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

  Lexapro (escitalopram) 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. Lexapro is 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

Product summary:

16.1 Tablets 5 mg Tablets: Bottle of 10                     NDC # 54868-5951-1 Bottle of 30                     NDC # 54868-5951-2 Bottle of 90                     NDC # 54868-5951-0 White to off-white, round, non-scored, film-coated. Imprint "FL" on one side of the tablet and "5" on the other side. 10 mg Tablets: Bottle of 10                     NDC # 54868-4700-0 Bottle of 20                     NDC # 54868-4700-4 Bottle of 30                     NDC # 54868-4700-1 Bottle of 45                     NDC # 54868-4700-5 Bottle of 60                     NDC # 54868-4700-2 Bottle of 90                     NDC # 54868-4700-6 Bottle of 100                   NDC # 54868-4700-3 White to off-white, round, scored, film-coated. Imprint on scored side with "F" on the left side and "L" on the right side. Imprint on the non-scored side with "10". 20 mg Tablets: Bottle of 10                     NDC # 54868-4775-0 Bottle of 30                     NDC # 54868-4775-1 Bottle of 45                     NDC # 54868-4775-3 Bottle of 60                     NDC # 54868-4775-4 Bottle of 90                     NDC # 54868-4775-5 Bottle of 100                   NDC # 54868-4775-2 White to off-white, round, scored, film-coated. Imprint on scored side with "F" on the left side and "L" on the right side. Imprint on the non-scored side with "20". Storage and Handling Store at 25°C (77°F); excursions permitted to 15 - 30°C (59-86°F).

Authorization status:

New Drug Application

Summary of Product characteristics

LEXAPRO - ESCITALOPRAM OXALATE TABLET
PHYSICIANS TOTAL CARE, INC.
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FULL PRESCRIBING INFORMATION
WARNINGS: SUICIDALITY AND ANTIDEPRESSANT DRUGS
ANTIDEPRESSANTS INCREASED THE RISK COMPARED TO PLACEBO OF SUICIDAL
THINKING AND BEHAVIOR
(SUICIDALITY) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS IN SHORT-TERM
STUDIES OF MAJOR
DEPRESSIVE DISORDER (MDD) AND OTHER PSYCHIATRIC DISORDERS. ANYONE
CONSIDERING THE USE OF
LEXAPRO OR ANY OTHER ANTIDEPRESSANT IN A CHILD, ADOLESCENT, OR YOUNG
ADULT MUST BALANCE
THIS RISK WITH THE CLINICAL NEED. SHORT-TERM STUDIES DID NOT SHOW AN
INCREASE IN THE RISK OF
SUICIDALITY WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS BEYOND
AGE 24; THERE WAS A
REDUCTION IN RISK WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS
AGED 65 AND OLDER.
DEPRESSION AND CERTAIN OTHER PSYCHIATRIC DISORDERS ARE THEMSELVES
ASSOCIATED WITH
INCREASES IN THE RISK OF SUICIDE. PATIENTS OF ALL AGES WHO ARE STARTED
ON ANTIDEPRESSANT
THERAPY SHOULD BE MONITORED APPROPRIATELY AND OBSERVED CLOSELY FOR
CLINICAL WORSENING,
SUICIDALITY, OR UNUSUAL CHANGES IN BEHAVIOR. FAMILIES AND CAREGIVERS
SHOULD BE ADVISED OF
THE NEED FOR CLOSE OBSERVATION AND COMMUNICATION WITH THE PRESCRIBER.
LEXAPRO IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS LESS THAN 12 YEARS OF AGE.[See
Warnings and
Precautions: Clinical Worsening and Suicide Risk (5.1), Patient
Counseling Information:
Information for Patients (17.1), and Used in Specific Populations:
Pediatric Use (8.4)].
1 INDICATIONS AND USAGE
1.1 Major Depressive Disorder
Lexapro (escitalopram) 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 w