Esmeron Use In Pregnancy & Lactation

rocuronium bromide




Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: For rocuronium bromide, no clinical data on exposed pregnancies are available. 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 Esmeron to pregnant women.
Cesarean section: In patients undergoing Cesarean section, Esmeron can be used as part of a rapid sequence induction technique, provided no intubation difficulties are anticipated and a sufficient dose of anesthetic agent is administered or following suxamethonium facilitated intubation. Esmeron, administered in doses of 0.6, has been shown to be safe in parturients undergoing Cesarean section. Esmeron does not affect Apgar score, fetal muscle tone nor 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 have been investigated during rapid sequence induction of anesthesia, but not in Cesarean section patients. Therefore, only a dose of 0.6 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 Esmeron should be reduced and be titrated to twitch response.
Lactation: It is unknown whether Esmeron is excreted in human breast milk. Animal studies have shown insignificant levels of Esmeron in breast milk. Esmeron should be given to lactating women only when the attending physician decides that the benefits outweigh the risks.
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