Entereg Pregnancy Warnings
Animal studies have failed to reveal evidence of fetal harm at oral doses up to 200 mg/day. 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.
The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned.
Risk Summary: There are insufficient data available on use of this drug in pregnant women to inform of a drug-related risk.
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Entereg Breastfeeding Warnings
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 (IV); Unknown (oral)
Comments:
-The effects in the nursing infant are unknown.
-The effects on milk production are unknown.
Drug and metabolite milk doses of approximately 15-fold and 0.11-fold of maternal plasma, respectively, were measured in animal models at 1 hour after administration of a 10 mg/kg/day IV dose.
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