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Pharmacotherapeutic group: Osmotically acting laxatives. ATC code: A06AD11.
Pharmacology: Pharmacodynamics: In the colon lactulose is broken down by colonic bacteria into low-molecular organic acids. These acids lower the pH in the colonic lumen and increase the volume of the colonic contents via an osmotic effect. These effects stimulate the peristalsis of the colon and return consistency to the stool. Constipation is corrected and the physiological rhythm of the colon is reinstated.
Lactulose as a prebiotic substance promotes the growth of normal flora, like Bifidobacterium and lactobacillus.
Pharmacokinetics: Lactulose is poorly absorbed after oral administration and reaches the colon unchanged. There it is metabolised by the colonic bacterial flora. Metabolism is complete at dose up to 25-50 g or 40-75 ml; at higher dosages, a proportion may be excreted unchanged.
Toxicology: Preclinical safety data: The results of acute, sub-chronic and chronic toxicity studies in various species indicate that the compound has very low toxicity. The effects observed, appear to be more related to the effect of bulk in the gastrointestinal tract than to a more specific toxic activity.
In reproduction and teratology experiments in rabbits, rats or mice no adverse effects were found.
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