Land: Canada
Språk: engelsk
Kilde: Health Canada
LACTULOSE
PHARMASCIENCE INC
A06AD11
LACTULOSE
667MG
SOLUTION
LACTULOSE 667MG
ORAL
1 L/15ML/30ML/250ML/500ML
OTC
AMMONIA DETOXICANTS
Active ingredient group (AIG) number: 0113020001; AHFS:
MARKETED
1996-10-16
PRESCRIBING INFORMATION PMS-LACTULOSE LACTULOSE SOLUTION, USP 667 MG/ML COLONIC CONTENT ACIDIFIER - LAXATIVE PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montreal, Quebec H4P 2T4 www.pharmascience.com Date of Revision: January 21, 2015 Submission Control No: 180273 _ _ _pms-LACTULOSE Prescribing Information _ _Page 2 of 14_ PRESCRIBING INFORMATION PMS-LACTULOSE LACTULOSE SOLUTION, USP 667 MG/ML THERAPEUTIC CLASSIFICATION Colonic Content Acidifier - Laxative ACTION AND CLINICAL PHARMACOLOGY pms-LACTULOSE (lactulose solution), a disaccharide sugar containing one molecule of galactose and one molecule of fructose, is a synthetic derivative of lactose. pms-LACTULOSE is a solution in water prepared from Lactulose concentrate. It contains lactulose, galactose, lactose, fructose and epilactose. In patients with portal-systemic encephalopathy (PSE), lactulose solution causes a decrease in blood ammonia concentration and reduces the degree of PSE. Although the mechanism of action of lactulose solution has not been clearly defined, it appears to be associated primarily with the metabolism of the sugar in the lower intestinal tract. The breakdown of lactulose solution to organic acids (i.e., lactic acid and small amounts of formic and acetic acids) by the saccharolytic bacteria in the colon acidifies the contents of the colon. In patients with PSE who respond to lactulose solution, a decrease in fecal pH occurs. Acidification of colon contents inhibits the _ _ _pms-LACTULOSE Prescribing Information _ _Page 3 of 14_ nonionic diffusion of ammonia from the colon into the blood. In addition, since the contents of the colon are more acidic than is blood, ammonia (NH 3 ) can diffuse from the blood into the colon. In the acidic colon, ammonia is converted to ammonium ions (NH4 + ) thereby preventing its absorption. In a similar manner, the absorption of amines (which may also contribute to the development of PSE) may also be reduced. Finally the cathartic action of lactulose solution (which is probably caused by the osmotic Les hele dokumentet