Aerobidol Use In Pregnancy & Lactation

Pregnancy: Oral reproduction studies were performed at ipratropium doses of 10 mg/kg in mice, 100 mg/kg in rats, and 125 mg/kg in rabbits. These doses correspond, in each species, respectively, to approximately 200, 40,000, and 10,000 times the maximum recommended human daily inhalation dose of ipratropium on a mg/m2 basis. Inhalation reproduction studies were conducted in rats and rabbits at dosages of 1.5 and 1.8 mg/kg/day (Approximately 60 and 140 times the maximum recommended human daily inhalation dosage on a mg/m2 basis for the HFA aerosol formulation and 38 and 45 times the recommended human daily dosage of ipratropium for the solution). These studies have demonstrated no evidence of teratogenic effects as a result of ipratropium.
At oral doses of 90 mg/kg and above in rats in the aerosol HFA formulation (approximately 3,600 times the maximum recommended daily inhalation dose of ipratropium in adults on a mg/m2 basis) embryotoxicity was observed as increased resorption. This effect is not considered relevant to human use due to the large doses at which it was observed and the difference in route of administration.
Adequate and well-controlled studies of fenoterol in humans have not been done. Direct blood and tissue studies in humans showed that the levels of fenoterol and its conjugates were 10 to 20 times lower in the fetus than in maternal tissues. Autoradiographic studies in pregnant rats showed no detectable amounts of fenoterol in the fetus. Direct blood and tissue studies in several animal species showed that levels of fenoterol and its conjugates were 10 to 20 times lower in the fetus than in maternal tissues.
There are no adequate or well controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, use ipratropium and fenoterol during pregnancy only if clearly needed. Nonetheless, the usual precautions regarding the use of drugs during pregnancy, especially during the 1st trimester, should be exercised.
Fenoterol contributes the inhibitory effect on uterine contraction during birth delivery so it should be taken into account.
There are no evidence that the drug affected the fertility but preclinical studies showed no adverse effect on fertility (see Precautions).
Lactation: It is not known whether ipratropium and fenoterol aerosol are excreted in human milk. Although lipid soluble quaternary cautions pass into breast milk, it is unlikely that the active component, ipratropium, would reach the infant to an important extent, especially when taken by inhalation. Ipratropium is not well absorbed systemically after inhalation or oral administration. However, because many drugs are excreted in human milk, exercise caution when ipratropium and fenoterol are administered to a breast-feeding woman.