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Cymbalta (duloxetine hydrochloride) is a selective serotonin and norepinephrine reuptake inhibitor for oral administration. Cymbalta is a white to slightly brownish white solid, which is slightly soluble in water.
Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, and 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the gastric area. Inactive ingredients of the drug includes FD&C Blue No. 2, gelatin, hypromellose, sugar spheres, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, talc, titanium dioxide, and triethyl citrate.
Cymbalta is indicated for the treatment of major depressive disorder and the efficacy of Cymbalta was formulated in four short term and one maintenance trial in adults.
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: significant change in weight and/or appetite , 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, or a suicide attempt or suicidal ideation.
Cymbalta is indicated for the treatment of generalized anxiety disorder and the efficacy of Cymbalta was established in three short-term trials and one maintenance trial in adults.
Generalized anxiety disorder is defined by the DSM-IV as excessive anxiety and worry, present more days than not, for a minimum of 6 months. The excessive anxiety and worry must be difficult to handle and must cause significant distress or impairment in normal functioning. It must be associated with at least 3 of the following 6 symptoms: restlessness or being easily fatigued, feeling keyed up or on edge, difficulty concentrating or mind going blank, irritability, muscle tension, and/or sleep disturbance.