Страна: Южна Африка
Език: английски
Източник: South African Health Products Regulatory Authority (SAHPRA)
Schering
DUPHALAC DRY SCHEDULING STATUS: Not scheduled PROPRIETARY NAME (and dosage form): DUPHALAC DRY Crystalline powder COMPOSITION 10 g of Duphalac Dry contains 10 g lactulose (4-0-beta-D-galactopyranosyl-D-fructofuranose) (a maximum of 0,25 g galactose and 0,2 g lactose). PHARMACOLOGICAL CLASSIFICATION A. 11.5 Laxatives. PHARMACOLOGICAL ACTION Duphalac is a synthetic disaccharide of fructose and galactose, which is not split into its monosaccharide constituents in the small intestine due to the lack of a specific enzyme. It reaches the colon unchanged where it is broken down by the saccharolytic flora into organic acids, such as lactic acid and acetic acid, acids formed in the colon under physiological conditions. Due to this local osmotic effect in the colon, water is retained, the faecal mass softened and normal colonic peristalsis restored. The mode of action differs from that of conventional laxatives. In portal systemic encephalopathy administration of large doses of Duphalac results in a significant reduction in the pH of the colonic contents. Lowering the pH promotes conversion of non-ionised ammonia into ionised form. The latter form being non-absorbable leads to reduction of absorption of ammonia from the intestine into the portal circulation and may even promote the excretion of ammonia from the circulation into the faeces. In addition, the enhanced growth of saccharolytic bacteria results in a decreased formation of ammonia. Duphalac cannot be hydrolysed in the intestine, thus very little absorption occurs. Small amounts of nonhydrolysed lactulose may be absorbed, but these are readily excreted via the kidneys. INDICATIONS a) Constipation: Particularly when associated with laxative habituation or for those patients in whom constipation presents a special problem, eg ch Прочетете целия документ