Isoflurane Pregnancy and Breastfeeding Warnings
Isoflurane Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk.
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.
Risk Summary: Animal studies revealed embryofetal toxicity manifested by increased post implantation losses and decreased live-birth index when this drug was given during organogenesis.
Animal studies have revealed evidence of embryotoxicity. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
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.
Isoflurane Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-Because the serum half-life of this drug in the mother is short and the drug is not expected to be absorbed by the infant, no waiting period or discarding of milk is required. Breastfeeding can be resumed as soon as the mother has recovered sufficiently from general anesthesia to nurse.
-When a combination of anesthetic agents is used for a procedure, follow the recommendations for the most problematic medication used during the procedure.
See also
References for pregnancy information
- Product Information. Forane (isoflurane). Baxter Pharmaceutical Products, Inc. 2009.
References for breastfeeding information
- Product Information. Forane (isoflurane). Baxter Pharmaceutical Products, Inc. 2009.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
