Animal studies have not been reported. There are no controlled data in human pregnancy.

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.

US FDA pregnancy category: Not assigned

Risk summary:
Rectal administration of this drug does not result in systemic absorption; exposure to the fetus is not expected.

See references

Use is considered acceptable.

Excreted into human milk: No
Excreted into animal milk: Unknown

Comments:
-The rectal route of administration of this drug does not result in systemic absorption.
-Breastfeeding is not expected to result in exposure of this drug to the child.

See references