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Ropivacaine Pregnancy and Breastfeeding Warnings

Ropivacaine is also known as: Naropin, Naropin Novaplus, Naropin Polyamp, Naropin SDV

Medically reviewed on Jun 18, 2018

Ropivacaine Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B1
US FDA pregnancy category: B

Comments:
-Fetal heart rate should be monitored continuously and electronic fetal monitoring is advisable.
-Maternal hypotension can result from regional anesthesia for obstetrical pain relief; elevating the patient's legs and positioning her on her left side will help prevent decreases in blood pressure.

Animal studies have failed to reveal evidence of teratogenicity nor any effects on late fetal development, parturition, lactation, neonatal viability, or growth of the offspring. One study involving administration at 23 mg/kg/day showed an increase loss of rat pups; however, this effect was considered secondary to impaired maternal care due to maternal toxicity. There are no controlled data in human pregnancy.

Local anesthetics rapidly cross the placenta and can cause varying degrees of maternal, fetal, and neonatal toxicity. The incidence and degree of toxicity are dependent upon procedure performed, type and amount of drug used, and technique of administration. Adverse reactions in the parturient, fetus, and neonate include alterations of the central nervous system, peripheral vascular tone, and cardiac function. Epidural anesthesia has been reported to prolong the second stage of labor.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Ropivacaine Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Yes

Comments:
-This drug has been used without apparent harmful effects in the nursing infant.
-This drug passes into milk poorly and is not orally absorbed by infants during breastfeeding.

Local anesthetics administered during labor and delivery with other anesthetics and analgesics have been reported to interfere with breastfeeding, however, this finding is controversial and complex due to many different combinations of drugs, doses, and patient populations studied and various techniques used. Labor pain medication may delay the onset of lactation. In a study involving 25 women undergoing cesarean section with ropivacaine and fentanyl demonstrated normal Apgar and Neurological and Adaptive Capacity scores in all 25 minutes; no adverse effects were observed.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Naropin (ropivacaine)." Astra USA, Westborough, MA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Naropin (ropivacaine)." Astra USA, Westborough, MA.
  4. 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 -]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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