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Sufentanil Pregnancy and Breastfeeding Warnings

Sufentanil is also known as: Sufenta

Sufentanil Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: Not Assigned

Risk Summary: Available data in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage; prolonged use during pregnancy may cause neonatal opioid withdrawal syndrome.

Comments:
-Neonates exposed to opioid analgesics during labor should be monitored for signs of excess sedation and respiratory depression.
-Prolonged maternal use of opioids during pregnancy can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.
-Sublingual use should be avoided during pregnancy and in women of childbearing potential not using contraception

Embryolethality and maternal toxicity were observed in rats given IV doses of 0.9 times the human procedural dose during organogenesis. This drug rapidly crosses the placenta and may produce respiratory depression in the neonate; IV use is generally not recommended during or immediately prior to labor when other analgesic techniques are more appropriate. Epidural use during labor and delivery has been used although high doses should be avoided because of potential risks to the newborn infant after delivery. As with other narcotics, opioid effects can be quickly reversed with naloxone. There are no adequate and well controlled studies in pregnant women.

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

Sufentanil Breastfeeding Warnings

Epidural use during labor or for a short-time immediately postpartum is not expected to cause adverse effects in breastfed infants. Use may delay onset of lactation, however with good breastfeeding support, epidural use is expected to have little to no effect on breastfeeding success. There is no data on IV use of this drug during established lactation, other agents may be preferred

US (IV, epidural): Benefit should outweigh risk
UK (sublingual): Not recommended

Excreted into human milk: Yes

Comments:
-Breastfed infants should be monitored for excess sedation and respiratory depression.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. SUFentanil Citrate (SUFentanil)." Akorn Inc, Buffalo Grove, 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. SUFentanil Citrate (SUFentanil)." Akorn Inc, Buffalo Grove, IL.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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

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