Pharmacology: Pharmacodynamics: Mechanism of Action: SIMETHICONE is a mixture of liquid Dimethylpolysiloxanes which have Antifoaming or Antibubbling activity. SIMETHICONE acts in the stomach and intestines by altering the surface tension of gas and mucus bubbles enabling them to coalesce. Coalescence of gas bubbles accelerates the passage of gas through the intestine either through belching, passing of flatus, or increased absorption of gas into the bloodstream.
Simethicone has been shown to have activity against Helicobacter pylori. The Minimal Inhibitory Concentration (MIC) for Simethicone against H. pylori ranges from 64 to 128 mg/L which can be achieved in the stomach with therapeutic doses. Simethicone is likely to be evaluated in combination therapy for the treatment of H. pylori-associated peptic ulcer disease (Ansorg et al, 1996).
Pharmacokinetics: No Pharmacokinetic data is available.
ADME: Excretion: Breast Milk: Breastfeeding: unknown.
Other: Other Excretion: FECES, good (USPDI, 1995): SIMETHICONE is excreted unchanged in the feces (USPDI, 1995).
Toxicology: Preclinical Safety Data: Preclinical Data reveal no special hazard for humans based on conventional studies of pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.