Sensorcaine-mpf Pregnancy Warnings
Use only if the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: A
US FDA pregnancy category: Not assigned
Comments:
-Use is contraindicated for obstetrical paracervical block anesthesia.
-Local anesthetics can rapidly cross the placenta and can cause varying degrees of maternal, fetal, and neonatal toxicity when used for epidural, caudal, or pudendal block anesthesia.
-This drug can cause maternal hypotension as well as fetal bradycardia. Both mother and fetus should be closely monitored after administration.
-Epidural, caudal, or pudendal anesthesia may affect uterine contractility and may prolong stages of labor.
-It is extremely important to avoid maternal aortocaval compression by the gravid uterus during administration of regional block. The patient should be maintained in left lateral decubitus position or a blanket roll or sandbag may be placed beneath the right hip and gravid uterus displaced to the left.
Animal studies have revealed evidence of developmental toxicity when administered subcutaneously at clinically relevant doses. An increase in embryofetal deaths was observed in rabbits at the highest dose when administered subcutaneously. There are no controlled data in human pregnancy.
AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
See references
Sensorcaine-mpf Breastfeeding Warnings
Studies to assess the effect of this drug on milk production or excretion and on nursing children have not been performed. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for treatment.
Use only if clearly indicated
Excreted into human milk: Yes
Comments: Lactation studies have not been conducted; however, the nursing infant could be exposed to the drug.
See references
