Bunascan Use In Pregnancy & Lactation



Full Prescribing Info
Use In Pregnancy & Lactation
Use in Pregnancy: Category A.
After epidural administration of bupivacaine to women in labour bupivacaine crosses the placental barrier. However, concentrations in umbilical veins are lower than those found in the maternal circulation. Bupivacaine has been effectively used for obstetrical analgesia and adverse effects on the course of labour or delivery are rare. It has been suggested that blood glucose levels should checked in newborns after obstetric regional anaesthesia.
Fetal adverse effects due to bupivacaine, such as fetal bradycardia, seem to be most apparent in paracervical block anaesthesia. Such effects may be due to high concentrations of anaesthetics reaching the fetus (see Contraindications).
The safe use of bupivacaine during pregnancy, other than labour, has not been established. Although bupivacaine has been used extensively for surgical procedures during pregnancy with no reports of ill effects to mother or fetus, there are no adequate and well-controlled studies in pregnant women of the effect of bupivacaine on the developing fetus. It should therefore be used cautiously during pregnancy other than labour.
Use during lactation: Bupivacaine passes into breast milk. The amount of bupivacaine appearing in breast milk from a nursing mother receiving parenteral bupivacaine is unlikely to lead to a significant accumulation of the parent drug in the breast-fed infant.
At maternal serum levels of up to 0.45 µg/mL produced by the epidural use of bupivacaine for vaginal delivery, bupivacaine could not be detected in breast milk during the first 24 hours after delivery (detection limit 0.02 µg/mL).
The possibility of an idiosyncratic or allergic reaction in the breast-fed infant from bupivacame remains to be determined.
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