Gastrointestinal anti-gas agent.
Pharmacology: Antifoaming Action: It has been observed in vitro that the drug breaks up small gas bubbles by lowering their surface tension and combining them into a free gas. Thus, the drug, in small quantities, has been observed to display a powerful antifoaming action.
Action on Removing Foaming Mucus Inside Stomach: In scanning electron-microscopic observations of the surface of rhesus monkey stomachs, the drug has been reported to have the effect of removing mucus attached to the inside walls of the stomachs.
Clinical Studies: Double-Blind Tests and General Clinical Trial: The following is an outline of double-blind tests (gastrointestinal symptoms eg, distention and meteorism) and of general clinical trial of 2194 patients. The total number of patients in Japan in whom it was possible to judge the effects was 2194. The drug was judged to be effective in 1849 of these, amounting to a total effective rate of 84.3%. See Table 1.
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Pharmacokinetics: Distribution: When doses of 500 mg/kg dimethylpolysiloxane were administered orally to male Wistar-type rats, only trace amounts were detected in the liver 1-3 hrs after administration and none was detected in the blood and other organs. Dimethylpolysiloxane passed rapidly through the stomach and small intestines and approximately 50% of it was excreted into the faeces within 6 hrs after administration and approximately 90% in 12-24 hrs. None was detected from the urine and almost all of it was excreted into the faeces.
Metabolism: A study of metabolites in rat faeces shows that dimethylpolysiloxane itself was contained in the faeces. It was excreted in its unmodified form.