Abelcet Pregnancy Warnings
Animal studies have revealed evidence of embryofetal toxicity in rabbits but have failed to reveal evidence of embryotoxicity, fetotoxicity, or teratogenicity in rats. Although not seen in the subsequent full study, a dose-ranging teratogenicity study in rabbits showed embryotoxic and fetotoxic effects at estimated exposures (based on Cmax) below those expected in patients; studies in rats showed no fetal harm at exposures similar to those expected therapeutically. There are no controlled data in human pregnancy.
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
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.
This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk.
AU TGA pregnancy category: B3
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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Abelcet Breastfeeding Warnings
LactMed: Use is generally considered acceptable.
-According to some authorities: Use is not recommended.
-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 to the child.
Excreted into human milk: Unknown
Excreted into animal milk: Unknown
No data available regarding the excretion of amphotericin B in milk; however, since it is highly protein bound, has a large molecular weight, is virtually unabsorbed orally, and has been used directly in infants' mouths, experts generally consider its use acceptable.
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