Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Lactulose
Noripharma Sdn. Bhd.
Lactulose
120ml mL; 100ml mL; 60ml mL; 200ml mL; 500ml mL
Noripharma Sdn. Bhd.
NOPHALAC SOLUTION 670MG/ML DESCRIPTION: Clear, viscous liquid, colourless or pale brownish-yellow with a sweet taste. COMPOSITION: Each ml of solution contains 670mg Lactulose PHARMACODYNAMIC: Lactulose, a synthetic disaccharide which is the active ingredient of NOPHALAC is metabolized in the colon by the sacchrolytic bacteria producing low molecular weight organic acid mainly lactic acid via bacterial degradation. This lowers the pH of the colon contents with stimulation of peristalsis by promoting the retention of water by an osmotic effect. In portal systemic encephalopathy (PSE) or (pre)coma hepaticum, the effect has been attributed to suppression of proteolytic bacteria by an increase of acidophilic bacteria (e.g. lactobacillus), trapping of ammonia in the ionic form by acidification of the colonic contents, catharsis due to the low pH in the colon as well as an osmotic effect, and alteration of the bacterial nitrogen metabolism by stimulating the bacteria to utilize ammonia for bacterial protein synthesis. PHARMACOKINETICS : Lactulose is minimally absorbed after oral administration. It reaches the colon unchanged, where it is metabolized by the colonic bacteria flora. Metabolism is completed at 20-50g or 40-75ml; at higher dosages, a proportion may be excreted unchanged. INDICATIONS: Constipation: Regulation of the physiological rhythm of the colon. Portal systemic encephalopathy (PSE): Treatment and prevention of hepatic coma or precoma. Where a soft stool is considered of medical benefit (haemorrhoids, after colon/anal surgery) DOSAGE & ADMINISTRATION: Lactulose can be taken as a single daily dose or in two divided doses. Dose need to be taken in one swallow. It should not be held in the mouth for length of time. Dosage will be adjusted to individual needs. NOPHALAC is best taken at the same time each day, preferably at breakfast time. Nophalac can be taken diluted or undiluted. ROUTE OF ADMINISTRATION: Oral administration DOSING IN CONSTIPATION OR WHERE SOFT STOOL IS CONSIDERED OF MEDICAL BENEFIT Adults Läs hela dokumentet