Animal studies did not identify any direct or indirect harmful effects with respect to reproductive toxicity. There were no detectable embryo-lethal or teratogenic effects in any animal species at the highest doses tested. Adverse outcomes related to maternal toxicity or reproductive performance were not observed in animal studies. 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.

The manufacturer makes no recommendation regarding use during pregnancy. Benefit should outweigh risk

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

Risk summary: There are insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-No adverse effects were detected in embryofetal development studies.

See references

Safety has not been established. Benefit should outweigh risk.

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

Comments:
-There is no information on the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production.
-Treatment with this drug is not a reason to discontinue breastfeeding in an older infant; however, an alternate drug may be preferred in a newborn or preterm infant.
-When a drug is excreted in animal milk, it is likely to be present in human milk; however, due the high protein binding of this drug (greater than 80%) the amount in human milk is expected to be low.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references