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Pregnancy Teratogenic Effects Pregnancy Category C Text Continues Below
Budesonide was teratogenic and embryocidal in rabbits and rats. Budesonide produced fetal loss, decreased pup weights, and skeletal abnormalities at subcutaneous doses of 25 mcg/ kg in rabbits and 500 mcg/ kg in rats (approximately 2 and 16 times the maximum recommended daily intranasal dose in adults on a mcg/ m 2 basis). In another study in rats, no teratogenic or embryocidal effects were seen at inhalation doses up to 250 mcg/ kg (approximately 8 times the maximum recommended daily intranasal dose in adults on a mcg/ m 2 basis). There are no adequate and well-controlled studies in pregnant women. RHINOCORT AQUA Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Experience with oral corticosteroids since their introduction in pharmaco-logic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. In addition, because there is a natural increase in corticosteroid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy. Nonteratogenic Effects Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully observed. Nursing Mothers It is not known whether budesonide is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exer-cised when RHINOCORT AQUA Nasal Spray is administered to nursing women. Pediatric Use Safety and effectiveness in pediatric patients below 6 years of age have not been established.
Controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of hypothalamic-pitu-itary-adrenal (HPA) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. Page: << Prev | 1 | 2 | 3 | 4 | Next >>
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