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Use in Pregnancy: There are very limited data on the use of rocuronium bromide during human pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Rocuronium bromide should only be given to pregnant women when strictly necessary and the attending physician decides that the benefits outweigh the risks. Use of rocuronium bromide during Caesarean section at doses of 0.6 mg/kg bodyweight does not effect the Apgar score, the foetal muscle tone or the cardiorespiratory adaptation.
From umbilical cord blood sampling it is apparent that only limited placental transfer of rocuronium bromide occurs, which does not lead to the observation of clinical adverse reactions in the new-born infant.
Note: doses of 1.0 mg/kg have been investigated during rapid sequence induction of anaesthesia, but not in Caesarean section patients.
Use in Lactation: There are no human data on the use of rocuronium bromide during lactation. Other medicinal products of this class show little excretion into breast milk and low resorption by the suckling child. Animal studies have shown excretion of rocuronium bromide in insignificant amounts in breast milk.
A decision on whether to continue/discontinue breast-feeding should be made taking into account the benefit of breast-feeding and the potential risk to the child.
