Fospropofol Pregnancy and Breastfeeding Warnings

Brand names: Lusedra

Fospropofol Pregnancy Warnings

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

US FDA pregnancy category: B

-Animal studies of high doses have failed to reveal evidence of teratogenicity or impairment of fertility; however high doses did show maternal toxicity. There are no controlled data in human pregnancy
-This drug is not recommended for use in labor and delivery, including Cesarean section deliveries. It is not known if it crosses the placenta; however, propofol is known to cross the placenta, and as with other sedative-hypnotic agents, administration may be associated with neonatal respiratory and cardiovascular depression.

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.

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Fospropofol Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comment:
-The effects in the nursing infant are unknown.

-No information is available on the clinical use of this drug during breastfeeding; however, it is rapidly metabolized to propofol in the body. Amounts of propofol in milk are very small and are not expected to be absorbed by the infant; however, some experts recommend withholding nursing for an unspecified time after administration, and resuming as soon as the mother has recovered sufficiently from general anesthesia to nurse and that discarding milk is unnecessary.
-When a combination of anesthetic agents is used for a procedure, the recommendations for the most problematic medication used during the procedure should be followed.

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Further information

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