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These features are consistent with either a direct toxic effect of SSRIs SNRIs or, possibly, a drug discontinuation syndrome? Nonteratogenic Effects Neonates exposed to SSRIs or serotonin and norepinephrine reuptake inhibitors (SNRIs), late in the third trimester developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Screening Patients for Bipolar Disorder A major depressive episode be the initial presentation of bipolar disorder? The risk of suicidality was most consistently observed in the MDD trials, but there were signals of risk arising from some trials in other psychiatric indications (obsessive compulsive disorder and social anxiety disorder ) as well! In rats, dietary doses of duloxetine up to 27 mg/kg/day in females (4 times the MRHD and 2 times the human dose of 120 mg/day on a mg/m 2 basis) and up to 36 mg/kg/day in males (6 times the MRHD and 3 times the human dose of 120 mg/day on a mg/m 2 basis) did not increase the incidence of tumors. Learn more about bipolar mania. In studies using a fixed-dose design, there was evidence of a dose-response relationship for ALT and AST elevation of >3 times the upper limit of normal and >5 times the upper limit of normal, respectively. Tumor incidence was not increased in male mice receiving duloxetine at doses up to 100 mg/kg/ (8 times the MRHD and 4 times the human dose of 120 mg/day on a mg/m 2 basis). Because it is possible that duloxetine and alcohol may interact to cause liver injury or that duloxetine may aggravate pre-existing liver disease, Cymbalta should ordinarily not be to patients with substantial alcohol use or evidence of chronic liver disease. As with other agents, Cymbalta should be used in patients a of mania. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. 5% in the Cymbalta and by 0. Labor and Delivery The effect of duloxetine on labor and delivery in humans is . As observed in DPNP trials, Cymbalta treatment worsens glycemic control in some with . Anyone considering the use of Cymbalta in a child or adolescent must balance the potential risks with the clinical need. 1 mm Hg in systolic blood pressure and up to 2. 1 mm Hg in systolic blood pressure and up to 2. Orthostatic Hypotension and Syncope Orthostatic hypotension and syncope have been reported with therapeutic doses of duloxetine. The estimated daily infant dose on a mg/kg basis is approximately 0. These reactions also been reported in patients who have recently discontinued serotonin reuptake inhibitors and are then started on an MAOI. 3% (2/652) of placebo-treated patients. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder.