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Warnings & Precautions
PRECAUTIONS
Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of desloratadine was assessed using loratadine studies. In an 18-month study in mice and a 2-year study in rats, loratadine was administered in the diet at doses up to 40 mg/ kg/ day in mice (estimated desloratadine and desloratadine metabolite exposures were approximately 3 times the AUC in humans at the recommended daily oral dose) and 25 mg/ kg/ day in rats (estimated desloratadine and desloratadine metabolite exposures were approximately 30 times the AUC in humans at the recommended daily oral dose). Text Continues Below
Male mice given 40 mg/ kg/ day loratadine had a significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas) than concurrent controls. In rats, a significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas) was observed in males given 10 mg/ kg/ day and in males and females given 25 mg/ kg/ day. The estimated desloratadine and desloratadine metabolite exposures of rats given 10 mg/ kg of loratadine were approximately 7 times the AUC in humans at the recommended daily oral dose. The clinical significance of these findings during long-term use of desloratadine is not known. In genotoxicity studies with desloratadine, there was no evidence of genotoxic potential in a reverse mutation assay (Salmonella/ E. coli mammalian microsome bacterial mutagenicity assay) or in two assays for chromo-somal aberrations (human peripheral blood lymphocyte clastogenicity assay and mouse bone marrow micro-nucleus assay). There was no effect on female fertility in rats at desloratadine doses up to 24 mg/ kg/ day (estimated deslorata-dine and desloratadine metabolite exposures were approximately 130 times the AUC in humans at the recommended daily oral dose). Page: 1 | 2 | 3 | Next >>
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