CYMBALTA SUMMARY
CYMBALTA®
(duloxetine hydrochloride) Delayed-release Capsules
Cymbalta® (duloxetine hydrochloride) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration.
Cymbalta is indicated for the treatment of major depressive disorder (MDD).
The efficacy of Cymbalta has been established in 8- and 9-week placebo-controlled trials of outpatients who met DSM-IV diagnostic criteria for major depressive disorder ( see CLINICAL STUDIES).
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 5 of the following 9 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, or a suicide attempt or suicidal ideation.
The effectiveness of Cymbalta in hospitalized patients with major depressive disorder has not been studied.
The effectiveness of Cymbalta in long-term use for major depressive disorder, that is, for more than 9 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use Cymbalta for extended periods should periodically evaluate the long-term usefulness of the drug for the individual patient.
Cymbalta is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy ( see CLINICAL STUDIES).
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