Effects of azatadine maleate on subjective appraisal and psychomotor functions relevant to driving performance

Abstract

Studies were carried out in normal healthy male subjects to assess the effects on psychomotor functions and subjective ratings of performance after acute administration of azatadine maleate, a potent antihistamine with additional antiserotonin activity. In the first trial, 2 mg azatadine was compared with another new antihistamine Sch 12169 (2 mg) and placebo. In a second trial, higher doses of azatadine (4 mg and 8 mg) were compared with dexchlorpheniramine (4 mg) and placebo. Both trials were of a double-blind, randomized Latin square design and subjects were assessed using a battery of tests, after administration of each trial drug. The time and sequence of tests were standarized, with a 1-week interval between test sessions. The results showed that azatadine did not produce significant impairment of psychomotor function at either the standard 2 mg or the maximum recommended 4 mg per day dosage level. Permormance was only significantly impaired, compared with that after placebo, at the 8 mg dose level and was of a similar order to that observed after dexchlorpheniramine at the usual 4 mg dosage. It is suggested, therefore, that at the normal recommended dosage of 2 mg per day, azatadine is not likely to impair driving ability.

Azatadine maleate in perennial allergic rhinitis: effects on clinical symptoms and choice reaction time.

“…At the maximum recommended dosage azatadine maleate produced varying degrees of sedation in eight of the twenty subjects. These results conflict with those of Biehl (1979) who found no impairment of psychomotor function at this dosage. However, Biehl's studies (1979) included only normal healthy men whereas ours had a majority of women and therefore the difference may well be dose related due to the expected differences in body weights of the two groups.…”

“…Hindmarch & Parrott, 1978;Idestrom, 1960;Idestrom, Schalling, Carlquist & Sjoquist, 1972), and have been utilised in various forms to evaluate antihistamines. Biehl (1979) found that performance in a complex reaction time test involving both hand and foot movements was significantly impaired by acute administration of 8 mg of azatadine maleate. Hindmarch & Parrott (1978), and Kulshrestha, Gupta, Turner & Wadsworth (1978) observed no impairment of performance in complex reaction time tasks after therapeutic doses of several different antihistamines.…”

H1-Receptor Antagonists

“…, 1977Carruthersetal.1978;Clarke & Nicholson 1978;Cohen et al 1985Cohen et al , 1987De Roeck et al 1990;Fink & Irwin 1979;Gengo et al 1987Gengo et al , 1989Gengo et al , 1990Goetz et al 1989Goetz et al , 1991Hiigermark et al 1985;Hindmarch & Bhatti 1987;Hindmarch & Parrott 1978;Kulshrestha et al 1978;Levander et al 1985Levander et al , 1991Meador et al 1989;Moser et al 1978; Moskowitz & Burns 1988;Nicholson & Stone 1982, 1986O'Hanlon 1988b;Pechadre et al 1988;Pishkin et al 1983;Preston et al 1992;Riedel et al 1987;Roehrs et al 1984;Rombaut et al 1991;Roth et al 1987;Seidel et al 1990;Simons et al 1994a,b;Vincent et al 1988;Volkerts et al 1992;Vuurman et al 1993;Walsh et al 1992). Impairment has also been documented to occur after ingestion of azatadine, brompheniramine, dimetindene, mequitazine, promethazine, trimeprazine and tripelennamine (Biehl 1979;Clarke & Nicholson 1978;Diaz-Guerrero et al 1956;Gaillard et al 1988;Goldstein et al 1968;…”

Complex Cognitive Performance and Antihistamine Use

“…These tasks were not found to be sensitive to 50 mg of benadryl (Carruthers, Shoeman, Hignite, and Azarnoff, 1978), but were reported to be sensitive to therapeutic doses of triprolidine (Bye, Claridge, Peck, and Plowman, 1977;Bye, Dewsbury, and Peck 1974). Results with azatadine are conflicting (Biehl, 1979;Levander, Hagermark, and Stahle, 1985).…”