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Duloxetine Hydrochloride

Brand and Other Names: Cymbalta
Mechanism of Action:
Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.
Indications:
Cymbalta® is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: • Major Depressive Disorder (MDD). Efficacy was established in four short-term and one maintenance trial in adults . • Generalized Anxiety Disorder (GAD). Efficacy was established in three short-term and one maintenance trial in adults. • Diabetic Peripheral Neuropathic Pain (DPNP). • Fibromyalgia (FM). • Chronic Musculoskeletal Pain.
Route: Oral
Dose:
• Cymbalta should generally be administered once daily without regard to meals. Cymbalta should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents be sprinkled on food or mixed with liquids. See package insert for complete information.
Adverse Reactions:
Most common adverse reactions (≥5% and at least twice the incidence of placebo patients): nausea, dry mouth, somnolence, fatigue, constipation, decreased appetite, and hyperhidrosis.
Contraindication:
• Use of a monoamine oxidase inhibitor concomitantly or in close temporal proximity. • Use in patients with uncontrolled narrow-angle glaucoma.
Warnings and Precautions:
• Suicidality: Monitor for clinical worsening and suicide risk. • Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with Cymbalta. Cymbalta should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Cymbalta should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. • Orthostatic Hypotension and Syncope: Cases have been reported with duloxetine therapy. See package insert for complete information.
See package insert for full prescribing information.