Noveron Use In Pregnancy & Lactation

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 pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing Rocuronium bromide to pregnant women.
Caesarean section: In patients undergoing Caesarean section, rocuronium bromide can be used as part of a rapid sequence induction technique, provided no intubation difficulties are anticipated and a sufficient dose of anaesthetic agent is administered or following suxamethonium facilitated intubation. However, rocuronium bromide administered in doses of 0.6 mg/kg may not produce adequate conditions for intubation until 90 seconds after administration. This dose has been shown to be safe in patients undergoing Caesarean section.
Rocuronium bromide does not affect Apgar score, foetal muscle tone or 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 effects in the newborn.
Note 1: Doses of 1.0 mg/kg have been investigated during rapid sequence induction of anaesthesia, but not in Caesarean section patients. Therefore, only a dose of 0.6 mg/kg is recommended in this patient group.
Note 2: Reversal of neuromuscular block induced by neuromuscular blocking agents may be inhibited or unsatisfactory in patients receiving magnesium salts for toxemia of pregnancy because magnesium salts enhance neuromuscular blockade. Therefore, in these patients the dosage of Noveron should be reduced and be titrated to twitch response.
Lactation: It is unknown whether rocuronium bromide is excreted in human breast milk. Animal studies have shown insignificant levels in breast milk. Insignificant levels of rocuronium bromide were found in the milk of lactating rats.
There are no human data on the use of rocuronium bromide solution for injection during lactation. Rocuronium bromide solution for injection should be given to lactating women only when the attending physician decides that the benefits outweigh the risks.