Use is not recommended. When possible, discontinue this drug 5 to 7 days prior to labor, delivery, or neuraxial blockade.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

Risk Summary: Available data from cases reported in published literature and postmarketing surveillance have not identified an association with use of this drug in pregnancy and major birth defects, miscarriage, or adverse fetal outcomes.

While this drug is known to cross the placenta, animal studies have failed to reveal evidence of fetal harm. Reproduction studies performed in rats and rabbits at doses of 500 and 300 mg/kg/day (65 and 78 times the recommended daily human dose, respectively, on a mg/m2 basis) revealed no evidence of impaired fertility or fetotoxicity. There are no controlled data in human pregnancy.

Use of this drug during labor or delivery will increase the risk of maternal bleeding and hemorrhage. Avoid neuraxial blockade during use of this drug.

AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

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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This drug has been used without apparent harmful effects. However, use is not recommended or contraindicated per some authorities. Benefit should outweigh risk in case of use during lactation.

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

Comments: The effects in the nursing infant are unknown.

See references