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Pregnancy: There are no data on the use of duloxetine in pregnant women. Studies in animals have shown reproductive toxicity at systemic exposure levels (AUC) of duloxetine lower than the maximum clinical exposure.
The potential risk for humans is unknown. As with other serotoninergic drugs, discontinuation symptoms may occur in the neonate after maternal duloxetine use near term. Duloxetine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Discontinuation symptoms (e.g., hypotonia, tremor, jitteriness, feeding difficulty, respiratory distress and seizures) may occur in the neonate after maternal duloxetine use near term. The majority of cases have occurred either at birth or within a few days of birth. Women should be advised to notify their physician if they become pregnant, or intend to become pregnant, during therapy.
Breastfeeding: Duloxetine is excreted into the milk of lactating women. The estimated daily infant dose on a mg/kg is approximately 0.14% of the maternal dose. Because the safety of duloxetine in infants is not known, breastfeeding while on duloxetine is not recommended.
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