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In an oral study, mometasone furoate increased resorptions and caused cleft palate and/ or head malformations (hydrocephaly or domed head) at 700 mcg/ kg (approximately 55 times the maximum rec-mmended daily intranasal dose in adults on a mcg/ m 2 basis). At 2800 mcg/ kg (approximately 230 times the maximum recommended daily intranasal dose in adults on a mcg/ m 2 basis), most litters were aborted or resorbed. No toxicity was observed at 140 mcg/ kg (approximately 10 times the maximum recommended daily intranasal dose in adults on a mcg/ m 2 basis). When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/ kg (less than the maximum recommended daily intranasal dose in adults on a mcg/ m 2 basis) caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/ kg (less than 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. NASONEX Nasal Spray, 50 mcg, like other corticosteroids, should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. Experience with oral corticosteroids since their introduction in pharmacologic, 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. Text Continues Below
Nonteratogenic Effects Hypoadrenalism may occur in infants born to women receiving corticosteroids during pregnancy. Such infants should be carefully monitored. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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