|
| Increased plasma concentrations of duloxetine, and especially of its metabolites, occur in with end-stage renal disease (requiring dialysis )? e. In the full cohort of placebo-controlled trials in any indication, elevation of ALT >3 times the upper limit of normal occurred in 1% (39/3732) of Cymbalta-treated patients compared to 0. 3% (2/652) of placebo-treated patients. , hyperreflexia, incoordination) /or gastrointestinal symptoms (e. When treating a pregnant woman with Cymbalta during the third trimester, the physician should carefully consider the potential risks and benefits of (see DOSAGE AND ADMINISTRATION ). WebMD Drug Avandia To Remain Despite Heart Attack Risk Drug May Fight Osteoarthritis Suspended IBS Drug Zelnorm OK'd For Read More » Take Control of Your Depression! Because the safety of duloxetine in infants is not known, nursing while on Cymbalta is not recommended? Labor and Delivery effect of duloxetine on labor and delivery in humans is unknown. The complete text of the Medication Guide is reprinted at the end of this document. Symptom Checker To check symptoms start here. When treating a pregnant woman with Cymbalta during the third trimester, the physician should carefully consider the potential risks and benefits of treatment (see DOSAGE AND ADMINISTRATION ). Click here for a screening tool? Of the patients in the DPN premarketing studies, 33% (357) were 65 years of age or over. In the extension phase of these studies, which up to 52 weeks, mean fasting blood glucose increased by 12 mg/dL in the Cymbalta group and decreased by 11. Because the safety of duloxetine in infants is not known, nursing while on Cymbalta is not recommended? Labor and Delivery The effect of duloxetine on labor and delivery in is unknown. Such monitoring should include daily observation by families and caregivers. 3 mm Hg in diastolic blood pressure. Therefore, patients should be cautioned about operating hazardous machinery including automobiles, until are reasonably certain that Cymbalta therapy does not affect their ability to engage in such activities. As with other antidepressants, Cymbalta has been associated with cases of clinically significant hyponatremia (seeHyponatremia, under PRECAUTIONS ). Because it is possible that duloxetine and alcohol may interact to cause liver injury or that duloxetine may liver disease, Cymbalta should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. Postmarketing reports indicate that elevated transaminases, bilirubin and alkaline phosphatase occurred in patients with chronic liver disease or cirrhosis. 8 mm Hg (systolic) and 4. Impairment of Duloxetine administered orally to either male or female rats prior to and throughout at doses up to 45 mg/kg/ (7 times the maximum recommended human dose of 60 mg/day and 4 times dose of 120 mg/day on a mg/m 2 basis) did not alter mating or fertility. |