Rythma Use In Pregnancy & Lactation





United Lab
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy Category D: Amiodarone is contraindicated during pregnancy because there have been reports of neonatal hypo- or hyperthyroidism from amiodarone use.
Amiodarone is excreted in breastmilk in significant quantities and is therefore contraindicated in breastfeeding.
Tablet: There is no sufficient experience regarding safe administration during pregnancy.
Amiodarone HCl and N-demethyl amiodarone pass the placenta and reach concentrations in the child of 10-25% of the maternal plasma concentration. Growth disturbances, premature births 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.
Due to the long t½ of amiodarone HCl, women who want to become pregnant should plan the beginning of a pregnancy 6 months after ending therapy at the earliest in order to avoid any exposure of the child in early pregnancy.
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 HCl has been taken during pregnancy, breastfeeding should be refrained from.
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