1 INDICATIONS AND USAGE Escitalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for: â€¢ Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years ( 1.1 ) â€¢ Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2 ) 1.1 Major Depressive Disorder 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. 1.2 Generalized Anxiety Disorder 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 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.
Mylan Pharmaceuticals Inc.
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Tablets Escitalopram Tablets, USP are available containing escitalopram oxalate, USP equivalent to 5 mg, 10 mg or 20 mg of escitalopram base. The 5 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and EC5 on the other side. They are available as follows: NDC 0378-3855-77 bottles of 90 tablets 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 0378-3856-77 bottles of 90 tablets NDC 0378-3856-10 bottles of 1000 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 0378-3857-77 bottles of 90 tablets NDC 0378-3857-10 bottles of 1000 tablets Storage and Handling: Store at 20Â° to 25Â°C (68Â° to 77Â°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.
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