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Pharmacotherapeutic class: Other intestinal adsorbents. ATC code: A07BC05.
Pharmacology: Pharmacodynamics: It has been demonstrated in clinical pharmacology studies that dioctahedral smectite: Adsorbs intestinal gas in adults; Restores normal permeability of the mucous membrane, observed during a clinical study in children with gastroenteritis.
Due to its layered structure and high plastic viscosity, dioctahedral smectite covers the intestinal mucosa.
The combined results of 2 double-blind randomized controlled trials comparing the efficacy of dioctahedral smectite against a placebo, in 602 patients aged 1 to 36 months who were suffering from acute diarrhea, show a significant reduction in stool output during the first 72 hours in the patient group treated with dioctahedral smectite combined with oral rehydration.
Pharmacokinetics: Given the layered structure of dioctahedral smectite, it stays on the luminal side of intestinal epithelium. It is neither absorbed nor metabolized.
Dioctahedral smectite is eliminated in the stool by the natural process of intestinal transit.
Toxicology: Preclinical safety data: Preclinical safety data from conventional acute and repeated-dose toxicity and genotoxicity studies show no evidence of particular risk to humans.
