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Ropivacaine Pregnancy and Breastfeeding Warnings

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

Ropivacaine Pregnancy Warnings

Ropivacaine has been assigned to pregnancy category B by the FDA. Animal studies utilizing doses up to 5 times the maximum recommended human dose have not revealed evidence of teratogenicity. Higher dosages (23 mg/kg) have resulted in increased pup loss during the first 3 days postpartum, thought to be secondary to decreased maternal care due to maternal toxicity. There are no controlled data in human pregnancy. Ropivacaine should be used in pregnancy only when need has been clearly established.

Ropivacaine has been shown to rapidly cross the placenta. Adverse reactions in the mother and/or neonate are dependent upon the route of administration, procedure and amount of drug used. Toxic reactions may include alterations in the central nervous system, peripheral vascular tone and cardiac function. Maternal hypotension during obstetrical procedures has occurred during regional anesthesia with ropivacaine. Elevating the patient's legs and positioning on the left side will help to prevent this effect. The fetal heart rate should be continuously monitored. Compared to bupivacaine 0.25%, ropivacaine 0.25% given by epidural infusion for pain relief during labor and delivery produced no significant differences in neonatal Apgar scores, umbilical acid-base status and neurological and adaptive capacity score at 2 and 24 hours after delivery. The ropivacaine group had a higher incidence of spontaneous vaginal delivery. Maternal pain relief was comparable and effective. In another comparative study, similar results were reported and, in addition, a lower percentage of instrumental deliveries occurred with ropivacaine.

See references

Ropivacaine Breastfeeding Warnings

There are limited data on the excretion of ropivacaine into human milk. However, animal studies suggest that the amount of ropivacaine that a nursing infant would be exposed to is considerably less than by exposure in utero at term.

See references

References for pregnancy information

  1. Griffin RP, Reynolds F "Extradural anaesthesia for caesarean section: a double-blind comparison of 0.5% ropivacaine with 0.5% bupivacaine." Br J Anaesth 74 (1995): 512-6
  2. Datta S, Camann W, Bader A, VanderBurgh L "Clinical effects and maternal and fetal plasma concentrations of epidural ropivacaine versus bupivacaine for cesarean section." Anesthesiology 82 (1995): 1346-52
  3. Eddleston JM, Holland JJ, Griffin RP, Corbett A, Horsman EL, Reynolds F "A double-blind comparison of 0.25% ropivacaine and 0.25% bupivacaine for extradural analgesia in labour." Br J Anaesth 76 (1996): 66-71
  4. Stienstra R, Jonker TA, Bourdrez P, Kuijpers JC, van Kleef JW, Lundberg U "Ropivacaine 0.25% versus bupivacaine 0.25% for continuous epidural analgesia in labor: a double-blind comparison." Anesth Analg 80 (1995): 285-9
  5. Writer WD, Stienstra R, Eddleston JM, et al. "Neonatal outcome and mode of delivery after epidural analgesia for labour with ropivacaine and bupivacaine: a prospective meta-analysis." Br J Anaesth 81 (1998): 713-7
  6. "Product Information. Naropin (ropivacaine)." Astra USA, Westborough, MA.
  7. de Jong RH "1995 Gaston Labat Lecture. Ropivacaine. White knight or dark horse?" Reg Anesth 20 (1995): 474-81

References for breastfeeding information

  1. "Product Information. Naropin (ropivacaine)." Astra USA, Westborough, MA.

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