Sedacoron Use In Pregnancy & Lactation

Pregnancy: Amiodarone has harmful pharmacological effects on pregnancy, the foetus and the newborn.
Amiodarone and N-demethyl amiodarone pass the placenta and reach concentrations in the child of 10-25% of the maternal plasma concentration. Growth disturbances, preterm birth and thyroid dysfunctions in the neonate are the most frequent complications. Hypothyroidism, bradycardia and prolonged QT intervals have been ascertained in approximately 10% of neonates. In isolated cases, thyroid enlargement or cardiac murmur have been found. The malformation rate does not seem to be increased. However, the possibility of cardiac defects should be taken into consideration.
Amiodarone must not be used during pregnancy unless clearly necessary.
Due to the long half-life of amiodarone, women who want to conceive should plan the beginning of a pregnancy six months after ending therapy at the earliest in order to avoid any exposure of the child in early pregnancy.
Breast-feeding: Transition into mother's milk is proven for the active substance and the active metabolite. Measurable plasma levels are reached in breast-fed children. If treatment is necessary in the lactation period or if amiodarone has been taken during pregnancy, breast-feeding should be refrained from.