This drug should be used during pregnancy only if the benefit outweighs the risk; some manufacturers consider this drug to be contraindicated in pregnancy.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk Summary: In animal reproduction studies, postimplantation loss, decreased pup survival, and increased maternal mortality was observed at exposures less than the human induction dose of 2.5 mg/kg. Administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours.

Comments:
-This drug should not be used for obstetric anesthesia because it crosses the placenta and may be associated with neonatal depression.

Animal studies have shown some evidence of delayed ossification or abnormal cranial ossification with an increase in the incidence of subcutaneous hematomas. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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.

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-Amounts of this drug in milk are very small and are not expected to be absorbed by the infant.
-Some experts recommend that women should not breastfeed for 24 hours after administration of this drug and any milk produced during this period should be discarded; however, others say that breastfeeding can be resumed 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.
-General anesthesia for cesarean section using this drug as a component for induction may delay the onset of lactation.

Use is not recommended; some manufacturers consider use to be contraindicated.

Excreted into human milk: Yes (in small amounts)

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

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