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TREVIGLIO.

A reduction in implants was also observed at an oral dose of 150 mgkgday. Oral doses of 150 and 300 mgkg of terfenadine produced AUC values of fexofenadine that were approximately 4 times the AUC at the maximum recommended human daily oral dose of ALLEGRA-D 12 HOUR. In mice, fexofenadine produced no effect on male or female fertility at average dietary doses up to 4438 mgkg (approximately 15 times the maximum recommended human daily oral dose of ALLEGRA-D 12 HOUR based on comparison of the AUCs). Teratogenic Effects. Category C. Terfenadine alone was not teratogenic in rats and rabbits at oral doses up to 300 mgkg; 300 mgkg of terfenadine produced fexofenadine AUC values that were approximately 4 and 30 times, respectively, the AUC at the maximum recommended human daily oral dose of ALLEGRA-D 12 HOUR.

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