Carbidopa / entacapone / levodopa Pregnancy and Breastfeeding Warnings

Carbidopa / entacapone / levodopa is also known as: Stalevo, Stalevo 100, Stalevo 125, Stalevo 150, Stalevo 200, Stalevo 50, Stalevo 75

Carbidopa / entacapone / levodopa Pregnancy Warnings

Carbidopa/levodopa/entacapone has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of visceral and skeletal malformation in rabbits at doses 5 to 20 times the maximum recommended human dose of levodopa-carbidopa. Two reports have described three patients who received levodopa or levodopa-carbidopa throughout pregnancy without evidence of fetal harm. Animal studies with entacapone have revealed evidence of increased frequencies of abortions, late/total resorptions, decreased fetal weighs, and an increased incidence of fetal eye anomalies (microphthalmia, microphthalmia, and anophthalmia). There are no controlled data in human pregnancy. Carbidopa/levodopa/entacapone is only recommended for use during pregnancy when benefit outweighs risk.

Carbidopa / entacapone / levodopa Breastfeeding Warnings

There are no data on the excretion of carbidopa/entacapone/levodopa into human milk. In animal studies, carbidopa and entacapone were excreted into maternal rat milk. The manufacturer recommends that caution be used when administering carbidopa/entacapone/levodopa to nursing women.

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