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HOME >> API >> API List1 >> Desloratadine >> Precaution

PRECAUTIONS
Desloratadine CAS Number 100643-71-8

Before taking desloratadine, tell your doctor or pharmacist if you are allergic to it; or to loratadine; or if you have any other allergies. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease. Limit alcohol intake, as it may intensify drug side effects. Desloratadine should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This medication passes into breast milk. Breast-feeding is not recommended while using this drug.

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). Male mice given 40 mg/kg/day loratadine had a significantly higher incidence of hepato-cellular 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 chromosomal aberrations (human peripheral blood lymphocyte clastogenicity assay and mouse bone marrow micronucleus assay).

There was no effect on female fertility in rats at desloratadine doses up to 24 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 130 times the AUC in humans at the recommended daily oral dose). A male specific decrease in fertility, demonstrated by reduced female conception rates, decreased sperm numbers and motility, and histopathologic testicular changes, occurred at an oral desloratadine dose of 12 mg/kg in rats (estimated desloratadine exposures were approximately 45 times the AUC in humans at the recommended daily oral dose). Desloratadine had no effect on fertility in rats at an oral dose of 3 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 8 times the AUC in humans at the recommended daily oral dose).

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