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

US FDA pregnancy category: Not Assigned

Risk Summary: Malformative risk with use of this drug in pregnant women is unlikely.

Comments:
-This drug has been shown to cross the placental barrier and appear in cord blood.

Animal studies have failed to reveal evidence of fetal harm at doses up to 20 times the maximum recommended human dose. 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.

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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: Data not available
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant are unknown.

Some experts recommend that if this drug is required by the mother, it may not be a reason to discontinue breastfeeding; however, because no information is available on its use during breastfeeding, an alternate drug may be preferred.

See references