Dalvance Pregnancy Warnings
Animal studies have failed to reveal evidence of malformations or embryofetal toxicity at clinically relevant exposures; animal studies have revealed evidence of delayed fetal maturation and increased fetal loss at higher exposures. No embryofetal toxicity was observed in the rabbit or rat at 0.7 and 1.2 times the human dose on an exposure basis, respectively; at 3.5 times the human dose on an exposure basis, delayed fetal maturation, increased embryolethality, and increased offspring deaths during the first week postpartum were seen in the rat. 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.
According to some authorities: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
US FDA pregnancy category: Not assigned.
Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.
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Dalvance Breastfeeding Warnings
If this drug is needed by the mother, it is not a reason to discontinue breastfeeding.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the child.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-An effect on the gastrointestinal or mouth flora of breastfed infants cannot be excluded; infants should be monitored for possible effects on the gastrointestinal tract (such as diarrhea, vomiting, candidiasis [e.g., thrush, diaper rash]).
This drug is highly bound to plasma protein and is poorly absorbed orally; it is not likely to reach the infant's bloodstream or cause any side effects in breastfed infants.
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