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
ROUND WHITE S10
S10 ROUND WHITE
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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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