Sevoflurane Pregnancy and Breastfeeding Warnings
Sevoflurane Pregnancy Warnings
Animal studies revealed no evidence of fetal harm or impaired fertility. A very small study during caesarian sections did not show any untoward effects on the mother or fetus. Safety in labor and delivery has not been demonstrated. There are no controlled data in human pregnancy. AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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.
This drug should be used during pregnancy only if clearly needed. AU TGA pregnancy category: B2 US FDA pregnancy category: B Comments: -This drug, like other inhalational agents, has relaxant effects on the uterus with the potential risk for uterine bleeding. -Use clinical judgment when using during obstetric anesthesia.
Sevoflurane Breastfeeding Warnings
Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -Advise women to skip breastfeeding for 48 hours after administration and discard milk produced during this period.
References for breastfeeding information
- "Product Information. Ultane (sevoflurane)." Abbott Pharmaceutical, Abbott Park, IL.
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