Aerotamol 100 Use In Pregnancy & Lactation

Pregnancy: There are no adequate and well-controlled studies of salbutamol sulfate in pregnant women. During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with salbutamol. Some of the mothers were taking multiple medications during their pregnancies. No consistent pattern of defects can be discerned, and a relationship between salbutamol use and congenital anomalies has not been established. Animal reproduction studies in mice and rabbits revealed evidence of teratogenicity. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Plasma levels of sulbutamol sulfate and HFA-134a after inhaled therapeutic doses are very low in humans, but it is not known whether the components of formula are excreted in human milk. Because of the potential for tumorigenicity shown for salbutamol in animal studies and lack of experience with the use by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Caution should be exercised when it is administered to a nursing woman.