DRUG INTERACTIONS
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 2-year study in rats, triamcinolone acetonide caused no treatment-related carcinogenicity at oral doses up to 1.0 mcg/kg (approximately 1/50 of the maximum recommended daily intranasal dose in adults and children on a mcg/m2 basis). In a 2-year study in mice, triamcinolone acetonide caused no treatment-related carcinogenicity at oral doses up to 3.0 mcg/kg (approximately 1/30 of the maximum recommended daily intranasal dose in adults and children on a mcg/m2 basis).
No evidence of mutagenicity was detected from in vitro tests (a reverse mutation test in Salmonella bacteria and a forward mutation test in Chinese hamster ovary cells) conducted with triamcinolone acetonide.
In male and female rats, triamcinolone acetonide caused no change in pregnancy rate at oral doses up to 15 mcg/kg (approximately 1/3 of the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). Triamcinolone acetonide caused increased fetal resorptions and stillbirths and decreases in pup weight and survival at doses of 5.0 mcg/kg and above (approximately 1/10 of the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). At 1.0 mcg/kg (approximately 1/50 of the maximum recommended daily intranasal dose in adults on a mcg/m2 basis), it did not induce the above mentioned effects.
Pregnancy
Teratogenic Effects
Pregnancy category C.
Triamcinolone acetonide was teratogenic in rats, rabbits, and monkeys. In rats, triamcinolone acetonide was teratogenic at inhalation doses of 20 mcg/kg and above (approximately 2/5 of the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). In rabbits, triamcinolone acetonide was also teratogenic at inhalation doses of 20 mcg/kg and above (approximately 4/5 of the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). In monkeys, triamcinolone acetonide was teratogenic at an inhalation dose of 500 mcg/kg (approximately 20 times the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). Dose-related teratogenic effects in rats and rabbits included cleft palate and/or internal hydrocephaly and axial skeletal defects, whereas the effects observed in monkeys were cranial malformations.
There are no adequate and well-controlled studies in pregnant women. Therefore, Nasacort HFA Nasal Aerosol 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 pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. In addition, because there is an increase in corticosteroid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy.
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