In animal studies, this drug did not impair fertility in males or females at doses up to 10-fold the maximum recommended human dose. There are no controlled data in human pregnancy.

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.

Use is considered acceptable.

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

Risk Summary: There are no data from the use of this drug in pregnant women; following oral administration, this drug is not absorbed systemically and therefore maternal use is not expected to result in fetal risk.

Comment:
-Some authorities recommend as a precautionary measure, it may be preferable to avoid use during pregnancy due to lack of data on use.

See references

Use caution

Excreted into human milk: Unknown (not expected)

Comment:
-This drug is not absorbed systemically following oral administration and therefore maternal use is not expected to result in infant risk.

See references