FEXOFENADINES EFFECTS, ALONE AND WITH ALCOHOL, ON ACTUAL DRIVING AND PSYCHOMOTOR PERFORMANCE

Background: Fexofenadine is the hydrochloride salt of terfenadine's ac tive metabolite. Objective: Fexofenadine's effects on performance were assessed in this study for the purpose of determining its safety of u se by patients wire engage in potentially dangerous activities, especi ally car driving. Methods: Fexofenadine was administered in daily dose s of 120 or 240 mg, each in single and divided units given over 5 days . Two milligrams of clemastine given twice daily and placebo were give n in similar series. Twenty-Four healthy volunteers (12 men, 12 women; age range, 21 to 45 years) participated in a double-blind six-way cro ssover study. Psychomotor tests (critical tracking, choice reaction ti me, and sustained attention) and a standardized actual driving test we re undertaken between 1.5 to 4 hours after administration of the morni ng dose on days I, 4, and 5 of each series. On day 5, subjects were ch allenged with a moderate alcohol dose before testing. Results: Fexofen adine did not impair driving performance. On the contrary, driving per formance was consistently better during twice daily treatment with 120 mg fexofenadine than during treatment with placebo, significantly so on day 4. Both of the 240 mg/day regimens significantly attenuated alc ohol's adverse effect: on driving on dag 5, Effects in psychomotor tes ts acre mot significant, with the exception of the critical tracking t est in which the first single doses of fexofenadine, 120 and 240 mg. h ad significantly impairing effects. Conclusion: It was concluded that fexofenadine has no effect ore performance after being taken in the re commended dosage of 60 mg twice daily.