| The no-effect dose was 50 mg/kg/day (4 times the MRHD and 2 times the human of mg/day on a mg/m 2 basis). Physician Directory Find a specialist near you. In female mice receiving duloxetine at 140 mg/kg/day (11 times the maximum recommended human dose and 6 times the human dose of 120 mg/day on a mg/m 2 basis), was an increased incidence of hepatocellular adenomas and carcinomas. g. Such should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. It should be noted that Cymbalta is not approved for use in treating bipolar depression. The effects of combined use of Cymbalta and MAOIs have not been evaluated in humans or animals. PRECAUTIONS General Hepatotoxicity Cymbalta increases the risk of elevation of serum transaminase levels. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome (see WARNINGS , Monoamine Oxidase Inhibitors). g. Activation of mania/hypomania has been reported in a small proportion of patients with mood disorders who were treated with other marketed effective in the treatment of major depressive disorder! All pediatric patients being treated with antidepressants for any indication should be observed closely for clinical worsening, suicidality, and changes in behavior, especially during the initial few months of a course of drug therapy, or at times of changes, either increases or decreases. Learn more about bipolar mania. g. 5mg/dL in the routine care . Disorder Information and Support Bipolar Mania. Patients with these diagnoses were generally excluded from clinical studies during the product’s premarketing testing. WebMD for additional health information on anxiety and depression. , tachycardia , labile blood pressure , hyperthermia), neuromuscular aberrations (e. Although these events are generally self-limiting, some have been reported to be severe. Additionally, duloxetine was not in an in vitro mammalian forward gene mutation in mouse lymphoma cells or in an in unscheduled DNA synthesis (UDS) assay in primary rat hepatocytes, and did not induce sister chromatid exchange in Chinese hamster bone marrow in vivo. Postmarketing reports indicate that elevated transaminases, bilirubin and alkaline phosphatase have occurred in patients with chronic liver disease or cirrhosis. g. Effect on Blood Pressure In clinical trials across indications, relative to placebo, duloxetine treatment was associated mean increases of up to 2. g. The average risk of events in patients receiving antidepressants was 4%, twice the risk of 2%. Cymbalta should be prescribed with care in patients with a history of a seizure disorder. Blood pressure should be measured prior to initiating treatment and periodically measured throughout treatment (see ADVERSE REACTIONS , Vital Sign Changes). You may freely link to RxList Find out how to add an RxList Search box to your website. |