Appropriately monitor & closely observe patients for clinical worsening, suicidality, & unusual changes in behavior, especially during the initial course of therapy, or at times of dose changes. Not approved for use in treating bipolar depression. Patients w/ depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. Risk of hepatic failure or aggravating pre-existing liver disease; orthostatic hypotension, falls & syncope; serotonin syndrome (particularly w/ other serotonergic drugs); severe skin reactions (eg, erythema multiforme & SJS); hyponatremia; urinary hesitation & retention. Increased risk of bleeding events. Risk of activation of mania or hypomania in patients w/ major depressive disorder. Risk of angle closure attack in patients w/ anatomically narrow angles who do not have a patent iridectomy. Caution in patients w/ history of seizure disorder; conditions that may slow gastric emptying (eg, DM); recent history of MI or unstable coronary artery disease. Gradual reduction in dose when discontinuing treatment is recommended. Measure BP prior to, & periodically throughout therapy. Glycemic control may worsen in some DM patients. Carefully evaluate patients for history of drug abuse & closely observe such patients for signs of misuse or abuse of Cymbalta. Concomitant use w/ other serotonergic drugs & drugs that impair metabolism of serotonin; potent CYP1A2 or CYP2D6 inhibitors; CYP2D6 substrates w/ narrow therapeutic index; alcohol; CNS-acting drugs. Avoid use in patients w/ chronic liver disease or cirrhosis, & in patients w/ severe renal impairment (GFR <30 mL/min). May cause symptoms of sexual dysfunction (ejaculatory delay or failure, decreased libido, erectile dysfunction in males; decreased libido & delayed or absent orgasm in females). Pregnancy & lactation. Elderly. Safety & effectiveness have not been established in ped patients for the treatment of major depressive disorder.
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