General: Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients.
Use of excessive doses of corticosteroids may lead to signs or symptoms of hypercorticism and/or suppression of HPA function.
Although systemic effects have been minimal with recommended doses of FLUTICASONE PROPIONATE Nasal Spray, potential risk increases with larger doses. Therefore, larger than recommended doses of FLUTICASONE PROPIONATE Nasal Spray should be avoided.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Fluticasone propionate demonstrated no tumorigenic potential in mice. Fluticasone propionate did not induce gene mutation in prokaryotic or eukaryotic cells in vitro. No significant clastogenic effect was seen in cultured human peripheral lymphocytes in vitro or in the mouse micronucleus test.
No evidence of impairment of fertility was observed in reproductive studies conducted in male and female.
Use in pregnancy: Teratogenic Effects: Pregnancy Category C.
There are no adequate and well-controlled studies in pregnant women.
Fluticasone propionate should be used during pregnancy only if the potential benefit justifies the potential risk to fetus.
Use in lactation: It is not known whether fluticasone propionate is excreted in human breastmilk.
Use in children: The potential for FLUTICASONE PROPIONATE Nasal Spray to cause growth suppression in susceptible patients or when given at higher doses cannot be ruled out.
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