국가: 캐나다
언어: 영어
출처: Health Canada
LACTULOSE
SANIS HEALTH INC
A06AD11
LACTULOSE
667MG
SOLUTION
LACTULOSE 667MG
ORAL
15G/50G
OTC
AMMONIA DETOXICANTS
Active ingredient group (AIG) number: 0113020001; AHFS:
APPROVED
2022-08-18
PRESCRIBING INFORMATION LACTULOSE LACTULOSE SOLUTION, USP 667 MG/ML COLONIC CONTENT ACIDIFIER - LAXATIVE SANIS HEALTH INC. 333 Champlain Street, Suite 102 Dieppe, New Brunswick E1A 1P2 www.sanis.com DATE OF REVISION: July 24, 2015 CONTROL NO.: 186111 _ _ _LACTULOSE Prescribing Information _ _Page 2 of 14_ PRESCRIBING INFORMATION LACTULOSE LACTULOSE SOLUTION, USP 667 MG/ML THERAPEUTIC CLASSIFICATION Colonic Content Acidifier - Laxative ACTION AND CLINICAL PHARMACOLOGY LACTULOSE (lactulose solution), a disaccharide sugar containing one molecule of galactose and one molecule of fructose, is a synthetic derivative of lactose. 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 _ _ _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 effect of the organic acid metabolites of 전체 문서 읽기