Terfenadine Fexofenadine hydrochloride

The carcinogenic potential and reproductive toxicity of fexofenadine hydrochloride were assessed using terfenadine studies with adequate fexofenadine hydrochloride exposure (based on plasma area under the concentration versus time (AUC) values). No evidence of carcinogenicity was observed in an 18 month study in mice and in a 24 month study in rats at oral doses up to 150 mg kg of terfenadine (which led to fexofenadine exposures that were, respectively, 3 and 5 times the exposure from the maximum recommended daily oral dose of fexofenadine hydrochloride in adults and children). 

Dose-related decreases in pup weight gain and survival were observed in rats exposed to an oral dose of 150 mg kg of terfenadine ( 3 times the maximum recommended daily oral dose of fexofenadine hydrochloride in adults based on comparison of fexofenadine hydrochloride AUCs). 

Telfast ) is a recently introduced drug, and is the active metabolite of terfenadine, one of the newer HISTAMINE Hi-RECEPTOR ANTAGONISTS with reduced SEDATIVE action. It is used orally in the treatment of allergic rhinitis, fexofenadine hydrochloride fexofenadine. 

---