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Use in Pregnancy: There are no adequate data from the use of the combination of levodopa/carbidopa/entacapone in pregnant women. Studies in animals have shown reproductive toxicity of the separate compounds (see Toxicology: Preclinical Safety Data under Actions). The potential risk for humans is unknown. Stalevo should not be used during pregnancy.
Use in Lactation: Levodopa is excreted in human breast milk. There is evidence that lactation is suppressed during treatment with levodopa. Carbidopa and entacapone were excreted in milk in animals but it is not known whether they are excreted in human breast milk. The safety of levodopa, carbidopa or entacapone in the infant is not known. Women should not breastfeed during treatment with Stalevo.
