Nasacort allergy 24hr nasal spray Pregnancy Warnings
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned
Animal studies indicate a teratogenic effect typical of corticosteroids. 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.
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Nasacort allergy 24hr nasal spray Breastfeeding Warnings
Safety has not been established
Excreted into human milk: Data not available
Excreted into animal milk: Data not available
Comments:
-Because no information is available, alternatives may be preferred, especially with newborns or preterm infants.
-Corticosteroids may reduce milk production.
-Use as a nasal spray would not be expected to cause adverse effects in the infant.
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