| There are no adequate and well-controlled studies in women; therefore, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome? Markedly increased exposure to duloxetine occurs in patients with hepatic insufficiency and Cymbalta should not be administered to these patients (see CLINICAL PHARMACOLOGY and AND ADMINISTRATION ). Furthermore, behaviors consistent with increased reactivity, as increased startle response to noise and decreased habituation of locomotor activity, were observed in pups following maternal exposure to 30 mg/kg/day. RxList does not provide medical advice, diagnosis or treatment. Although a causal link between the emergence of such either the worsening of and/or the of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality. Serotonin syndrome symptoms may include mental status changes (e. Markedly increased to duloxetine occurs in patients with hepatic insufficiency and Cymbalta should not be administered to these patients (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION ). For this reason, Cymbalta is not recommended for patients with end-stage renal disease or severe renal impairment ( creatinine clearance <30 mL/min) (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION ). Activation of Mania/Hypomania In placebo-controlled trials in patients with major depressive disorder, of mania or hypomania was reported in 0! In the MDD and DPN studies, no differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in between the elderly and younger patients, but greater of some older individuals cannot be ruled out. 04% (3/8504) of patients treated with duloxetine and 0. Postmarketing reports indicate that elevated transaminases, bilirubin and alkaline phosphatase have occurred in patients with chronic liver disease or cirrhosis. Impairment of Fertility Duloxetine administered orally to either male or female rats prior to and mating at doses up to 45 mg/kg/ (7 times maximum recommended human dose of 60 mg/day and 4 times the human dose of 120 mg/day on a mg/m 2 basis) did not alter mating or fertility. Families and caregivers of adults being treated for depression should be similarly advised. Based on the half-life of Cymbalta, at least 5 days should be allowed after stopping Cymbalta before starting an MAOI? stories from other bipolar mania patients. As with these other agents, Cymbalta should be cautiously in patients with a history of mania. Liver transaminase elevations resulted in the discontinuation of 0? The concomitant use of Cymbalta with serotonin precursors (such as tryptophan ) is not recommended (see PRECAUTIONS , DRUG INTERACTIONS ). |