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Bupivacaine Pregnancy and Breastfeeding Warnings

Bupivacaine is also known as: Marcaine, Marcaine HCl, Marcaine Spinal, Sensorcaine, Sensorcaine-MPF, Sensorcaine-MPF Spinal

Bupivacaine Pregnancy Warnings

Use is not recommended unless the benefit outweighs the risk to the fetus AU TGA pregnancy category: A US FDA pregnancy category: C Comments: -Use is contraindicated for obstetrical paracervical block anesthesia. -The dose should be reduced in the late stages of pregnancy. -Consider monitoring blood glucose levels in the newborn following use of obstetric regional anesthesia. -Fetal heart rate should be monitored continuously and electronic fetal monitoring is advisable.

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. Local anesthetics rapidly cross the placenta and can cause varying degrees of maternal, fetal, and neonatal toxicity. Spinal anesthesia has a recognized use during labor and deliver. This drug, when administered properly, via the epidural route in doses 10 to 12 times the amount used in spinal anesthesia, has been used for obstetrical analgesia and anesthesia without evidence of adverse effects on the fetus. There are no controlled data in human pregnancy. It is of utmost importance to avoid aortocaval compression by the gravid uterus during administration of regional block to parturients. The patient must be maintained in the left lateral decubitus position or a blanket roll or sandbag may be placed beneath the right hip and gravid uterus displaced to the left. 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Bupivacaine Breastfeeding Warnings

Milk levels were measured in 5 women who were given epidural bupivacaine analgesia for vaginal delivery; this drug was undetectable (less than 20 mcg/L) in all samples taken at 2, 8, 24, and 48 hours postpartum. In a separate study, 10 women received bupivacaine 0.5% as 0.5 mL (2.5 mg) boluses as needed up to 150 mg (mean 82.5 mg). This drug was detected in breast milk 30 minutes after administration, with the peak milk concentration of about 0.2 mg/L occurring about 2 hours after administration.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes Comments: Due to low levels in breast milk and lack of oral absorption, amounts received by the infant are small and is unlikely to cause any adverse effects in breastfed infants.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Bupivacaine Hydrochloride, Spinal (bupivacaine)." Claris Lifesciences Inc, North Brunswick, NJ.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Marcaine HCl (bupivacaine)." Hospira Inc, Lake Forest, IL.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Marcaine HCl (bupivacaine)." Hospira Inc, Lake Forest, IL.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Bupivacaine Hydrochloride, Spinal (bupivacaine)." Claris Lifesciences Inc, North Brunswick, NJ.

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