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

AU TGA pregnancy category: B2
US FDA pregnancy category: Not Assigned

Comments:
-Efficacy of hormonal contraceptives may be reduced for up to 7 days after administration.
-Additional, non-hormonal contraception should be used for 7 days after administration.

Animal studies showed no evidence of teratogenicity when exposed during organogenesis, but there was an increase in incomplete ossification of the sternebra and reduced fetal weights with daily doses 8 times the maximum recommended human dose; maternal toxicity was also observed at this dose. 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 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.

See references

Animal studies showed a maximum drug level at about 30 minutes after dosing, and a milk to plasma level of approximately 1:1; oral exposure via milk did not affect survival, body weight, or physical or behavioral developmental parameters in pre- or post-natal studies.

Caution is recommended.

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

See references