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escitalopram tablet film coated

1 INDICATIONS & USAGE Escitalopram tablets, USP 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 ) 1.1 Major Depressive Disorder Escitalopram tablets, USP 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. 1.2 Generalized Anxiety Disorder 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 for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.

STI Pharma LLC


3 years ago ROUND WHITE S10 escitalopram tablet film coated

ROUND WHITE S10

3 years ago ROUND WHITE S10 escitalopram tablet film coated

S10 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Tablets Escitalopram tablets, USP are available as follows: 5 mg – Each white to off-white, round, film coated tablet imprinted with S 5 contains escitalopram oxalate, USP equivalent to 5 mg escitalopram. Tablets are supplied in bottles of 100 (NDC 54879-009-01) with a child-resistant closure 10 mg – Each white to off-white, round, film coated tablet imprinted with S 10 and a bisect on the other side contains escitalopram oxalate, USP equivalent to 10 mg escitalopram. Tablets are supplied in bottles of 100 (NDC 54879-010-01) and 500 (NDC 54879-010-05) with a child-resistant closure 20 mg – Each white to off-white, round, film coated tablet imprinted with S 20 and a bisect on the other side contains escitalopram oxalate, USP equivalent to 20 mg escitalopram. Tablets are supplied in bottles of 100 (NDC 54879-011-01) and 500 (NDC 54879-011-05) with a child-resistant closure To report SUSPECTED ADVERSE REACTIONS, contact STI Pharma, LLC at 1-888-301-9680 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C with excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Keep container tightly closed. PHARMACIST: Dispense a Medication guide with each prescription.


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