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escitalopram as escitalopram oxalate 10 MG Oral Tablet

1 INDICATIONS AND USAGE Escitalopram tablets 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 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.


10 years ago ROUND WHITE M EC 10 escitalopram as escitalopram oxalate 10 MG Oral Tablet

ROUND WHITE M EC 10

10 years ago ROUND WHITE M EC 10 escitalopram as escitalopram oxalate 10 MG Oral Tablet

M EC 10 ROUND WHITE

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 20° to 25°C (68° to 77°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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