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Pharmacotherapeutic group: other intestinal adsorbents. ATC code: A07BC05.
PHARMACOLOGY: Pharmacodynamics: Diosmectite has been demonstrated in Clinical Pharmacology: to adsorb intestinal gas in adults; to restore normal mucosal permeability in a clinical study performed in children with gastroenteritis.
With its structure and high plastic viscosity, diosmectite has a powerful coating property on the digestive mucosa.
The combined results of the 2 double blind randomized studies that compare the efficacy of SMECTAGO against placebo and which included 602 patients aged between 1 and 36 months, suffering from acute diarrhea, demonstrate a significant reduction in stool output emitted during the first 72 hours, in the group of patients treated by SMECTAGO, in addition to oral rehydration.
Pharmacokinetics: Given the structure of diosmectite, SMECTAGO is confined to the luminal side of the epithelium. It is neither absorbed nor metabolized.
Diosmectite is eliminated in the faeces through the process of normal intestinal transit.
Toxicology: Pre-clinical safety data: The pre-clinical safety data, obtained from standard acute toxicity studies and at repeated doses, and from genotoxicity studies show no evidence of particular risk to humans.
