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Class ⬇

Antidote (Acetaminophen)/Respiratory (Mucolytic)

PREGNANCY RECOMMENDATION:Limited Human Data—Animal Data Suggest Low Risk (Maternal Benefit Probably Outweighs Any Embryofetal Risk With Overdose)

BREASTFEEDING RECOMMENDATION:Probably Compatible

Pregnancy Summary ⬆ ⬇

No reports describing the use of acetylcysteine with inhalation use during human pregnancy have been located. A few publications on its use in treating acetaminophen overdose were found. Over 60 pregnancy exposures have been described, but only a few were in the first trimester and no outcome data specific for these were provided. Overall, no major adverse effects related to the drug were found. Most of the poor outcomes were due to adverse effects caused by the drug overdose. The drug will probably cross the placenta, so some fetal exposure will likely occur. Therefore, this limited human pregnancy experience prevents a complete assessment of the embryofetal risk. Animal data did not show any embryofetal toxicity in two species at doses of less than 10 times the RHD. However, due to the severe consequences related to acetaminophen overdose, the drug should be used in the same manner as it is used in nonpregnant patients.

Breastfeeding Summary ⬆ ⬇

No reports describing the use of acetylcysteine during human lactation have been located. The drug will likely be found in breast milk, so some infant exposure will likely occur. The amount of the drug in breast milk is likely to be much lower with inhalation use than with levels following intravenous (IV) use. In addition, IV use is for treating an acetaminophen overdose, which is not likely to occur often in a breastfeeding woman. Moreover, acetylcysteine has been administered to preterm neonates for therapeutic indications, without causing any toxicity, at doses far above those that would be obtained from breast milk following inhalation use. Breastfeeding while using this drug should be based on the mother’s clinical need for treatment versus any potential infant risks that might occur. If used, the infant should be monitored for the most common reported adult side effects of nausea (leading to irritability), cough, vomiting, fever, rhinorrhea, and sweating.

Reference ⬆

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