Clarinex - Warnings & Precautions

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Pregnancy Category C:

Desloratadine was not teratogenic in rats at doses up to 48 mg/ kg/ day (estimated desloratadine and desloratadine metabolite exposures were approximately 210 times the AUC in humans at the recommended daily oral dose) or in rabbits at doses up to 60 mg/ kg/ day (estimated desloratadine exposures were approximately 230 times the AUC in humans at the recommended daily oral dose). In a separate study, an increase in pre-implantation loss and a decreased number of implantations and fetuses were noted in female rats at 24 mg/ kg (estimated desloratadine and desloratadine metabolite exposures were approximately 120 times the AUC in humans at the recommended daily oral dose).

Reduced body weight and slow righting reflex were reported in pups at doses of 9 mg/ kg/ day or greater (estimated desloratadine and desloratadine metabolite exposures were approximately 50 times or greater than the AUC in humans at the recommended daily oral dose). Desloratadine had no effect on pup development at an oral dose of 3 mg/ kg/ day (estimated desloratadine and desloratadine metabolite exposures were approximately 7 times the AUC in humans at the recommended daily oral dose).

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, desloratadine should be used during pregnancy only if clearly needed.

Nursing Mothers

Desloratadine passes into breast milk, therefore a decision should be made whether to dis-continue nursing or to discontinue desloratadine, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and effectiveness of CLARINEX Tablets in pediatric patients under 12 years of age have not been established.

Geriatric Use

Clinical studies of desloratadine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. (see CLINICAL PHARMACOLOGY Ð Special Populations).