PK-Merz Use In Pregnancy & Lactation

Pregnancy: No data are available on placental transfer. There are no adequate data from the use of amantadine in pregnant women. There have been some case reports of healthy births but also of pregnancy complications and five cases of birth defects (cardiovascular defects, limb anomalies). In animal studies, amantadine was shown to be embryotoxic and teratogenic. The potential risk for humans is not known. Amantadine may therefore only be used during pregnancy if considered absolutely essential. If therapy is carried out during the 1st trimester, ultrasonography should be performed. If amantadine is prescribed to a woman of child-bearing age, the patient should be instructed to contact her doctor immediately if she wishes to become pregnant or suspects that she is pregnant.
Lactation: Amantadine is excreted into the breast milk. If use during lactation is considered absolutely essential, the infant should be kept under observation, due to possible drug-related symptoms (skin rash, urinary retention, vomiting) and weaned if necessary.