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Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovarycell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay and a rat bone marrow chromosomal aberration assay or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes. In reproductive studies in rats, impairment of fertility was not produced by subcutaneous doses up to 15 mcg/ kg (less than the maximum recommended daily intranasal dose in adults on a mcg/ m 2 basis). Pregnancy Teratogenic Effects: Text Continues Below
Pregnancy Category C: When administered to pregnant mice, rats, and rabbits, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/ or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy. In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/ kg and above (approximately equivalent to the maximum recommended daily intranasal dose in adults on a mcg/ m 2 basis). Fetal survival was reduced at 180 mcg/ kg (approximately 4 times the maximum recommended daily intranasal dose in adults on a mcg/ m 2 basis). No toxicity was observed at 20 mcg/ kg (less than the maximum recommended daily intranasal dose in adults on a mcg/ m 2 basis). In rats, mometasone furoate produced umbilical hernia at topical dermal doses of 600 mcg/ kg and above (approximately 25 times the maximum recommended daily intranasal dose in adults on a mcg/ m 2 basis). A dose of 300 mcg/ kg (approximately 10 times the maximum recommended daily intranasal dose in adults on a mcg/ m 2 basis) produced delays in ossification, but no malformations. In rabbits, mometasone furoate caused multiple malformations (eg, flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical dermal doses of 150 mcg/ kg and above (approximately 10 times the maximum recommended daily intranasal dose in adults on a mcg/ m 2 basis). Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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