Acode 50 Use In Pregnancy & Lactation

Women of childbearing potential/Contraception in males and females: There was no clinically relevant interaction between lacosamide and oral contraceptives (ethinylestradiol and levonorgestrel) in clinical studies (see Interactions).
Pregnancy: There are no adequate data from the use of Lacosamide in pregnant women. Studies in animals did not indicate any teratogenic effects in rats or rabbits, but embryotoxicity was observed in rats and rabbits at maternal toxic doses. The potential risk for humans is unknown.
Lacosamide should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the fetus). If women decide to become pregnant, the use of this product should be carefully re-evaluated.
Lactation: It is unknown whether lacosamide is excreted in human breast milk. Animal studies have shown excretion of lacosamide in breast milk.
Because many drugs are excreted into human milk, a decision should be made whether to discontinue nursing or to discontinue lacosamide, taking into account the importance of the drug to the mother.
Fertility: No adverse reactions on male or female fertility or reproduction were observed in rats at doses producing plasma exposures (AUC) up to approximately 2 times the plasma AUC in humans at the maximum recommended human dose (MRHD).