Animal studies have not been reported. In a tissue cross reactivity study with the active components using human fetal tissues, no binding of clinical concern was detected. There are no controlled data in human pregnancy.

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

Comments:
-Insufficient data are available on use of this product in pregnant women; no nonclinical reproductive toxicity studies have been performed with the active components.
-Human immunoglobulin G1 (IgG1) antibodies cross the placental barrier; the active components have the potential to be transferred from the mother to the developing fetus.

See references

Benefit should outweigh risk.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this product.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this product or the mother's underlying condition should be considered.

See references