Tolerability of fentonium bromide in indonesian volunteers

A double-blind crossover trial was carried out in 24 healthy Indonesian volunteers to assess the incidence of atropine-like side-effects after a single oral 80 mg dose of fentonium bromide compared with that after a single oral 80 mg dose of hyoscine-N-butyl bromide, and of placebo. Assessments of side-effects were made on subjective responses and objective measurements taken before, 2 hours, and 4 hours after administration of the drugs. The results showed that fentonium bromide did not produce significant atropine-like side-effects. Uyoscine-N-butyl bromide, however, did have a slight effect on pulse rate, although not of significance clinically, and produced a statistically significant, transient decrease in salivation.