Animal studies have revealed evidence of teratogenicity, stillbirths, and malformations (e.g., hydronephrosis, malformed iris, retinal dysplasia, retroesophageal subclavian artery) at doses approximately equal to the maximum recommended human dose.

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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

AU TGA pregnancy category: B2
US FDA pregnancy category: C

Comments:
-Some authorities state that use is contraindicated during lactation.
-Some experts state that this drug may be used following a risk/benefit analysis in patients who cannot abstain from drinking alcohol without treatment AND when there is a risk of fetotoxicity or teratogenicity due to alcohol.

See references

Use is not recommended, and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-The effects in the nursing infant are unknown.
-Some authorities state that use is contraindicated during lactation.
-Some experts recommend using this drug with caution

In animal models, the concentration ratio of drug in milk to blood was 1.3 to 1.

See references