Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: Fresenius Kabi Austria GmbH, Hafnerstraße 36, 8055 Graz, Austria
Pharmacotherapeutic group: Osmotically acting laxatives
ATC code: A06AD11
Lactulose is a synthetic disaccharide formed from D-galactose and fructose. In the colon lactulose is metabolised by bacterial enzymes to short chained fatty acids mainly lactic and acetic acid as well as methane and hydrogen. This effect leads to a decrease of the pH-value and an increase of the osmotic pressure in the colon. This causes stimulation of peristalsis and an increase of the water content of the faeces.
Lactulose as a prebiotic substance strengthens the growth of bifidobacteria and lactobacilli, whereas clostridium and Escherichia coli may be suppressed.
Lactulose is practically not absorbed, because in man there is no corresponding disaccharidase available in the upper intestinal tract. Not being absorbed as such, it reaches the colon unchanged. There it is metabolised by the colonic bacterial flora. Metabolism is complete at doses up to 25-50 g or 40-75 ml; at higher dosages, a proportion may be excreted unchanged.
Non-clinical data reveal no special hazard for humans based on studies of single and repeated dose toxicity. A long term animal study does not indicate a carcinogenic potential. Tests on genotoxicity are not available. Lactulose was not teratogenic in mice, rats and rabbits. There is no data available on fertility and on the development pre and postnatal exposure.
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