מדינה: סינגפור
שפה: אנגלית
מקור: HSA (Health Sciences Authority)
Bisacodyl
OPELLA HEALTHCARE SINGAPORE PTE. LTD.
A06AB02
5.0000mg
ENTERIC COATED TABLET
Bisacodyl 5.0000mg
ORAL
General Sale List
Delpharm Reims
ACTIVE
1989-04-28
1 | P a g e DULCOLAX ® abcd COMPOSITION 1 coated tablet contains 5 mg 4,4’-diacetoxy-diphenyl-(pyridyl-2)-methane (= bisacodyl) PRODUCT DESCRIPTION Round, beige yellow biconvex, sugar/enteric-coated tablets with a smooth, shiny surface and a white core. PROPERTIES Bisacodyl is a locally acting laxative from the diphenylmethane derivatives group. As a contact laxative, for which also antiresorptive hydragogue effects have been described, bisacodyl stimulates, after hydrolysis in the large intestine, peristalsis of the colon and promotes accumulation of water, and consequently electrolytes, in the colonic lumen. This results in a stimulation of defecation, reduction of transit time and softening of the stool. As a laxative that acts on the colon, bisacodyl specifically stimulates the evacuation process in the lower region of the gastrointestinal tract. Therefore, bisacodyl is ineffective in altering the digestion or absorption of calories or essential nutrients in the small intestine. PHARMACOKINETICS Following either oral or rectal administration, bisacodyl is rapidly hydrolyzed to the active principle bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), mainly by esterases of the enteric mucosa. Administration as an enteric coated tablet was found to result in maximum BHPM plasma concentrations between 4 - 10 hours post administration whereas the laxative effect occurred between 6 - 12 hours post administration. In contrast, following the administration as a suppository, the laxative effect occurred on average approximately 20 minutes post administration; in some cases it occurred 45 minutes after administration. The maximum BHPM-plasma concentrations were achieved 0.5 - 3 hours following the administration as a suppository. Hence, the la קרא את המסמך השלם
COMPOSITION 1 coated tablet contains 5 mg 4,4’-diacetoxy-diphenyl-(pyridyl-2)-methane (= bisacodyl) PRODUCT DESCRIPTION Round, beige yellow biconvex, sugar/enteric- coated tablets with a smooth, shiny surface and a white core. PHARMACOLOGICAL PROPERTIES ATC code: A06AB02 Bisacodyl is a locally acting laxative from the diphenylmethane derivatives group. As a contact laxative, for which also antiresorptive hydragogue effects have been described, bisacodyl stimulates, after hydrolysis in the large intestine, peristalsis of the colon and promotes accumulation of water, and consequently electrolytes, in the colonic lumen. This results in a stimulation of defecation, reduction of transit time and softening of the stool. As a laxative that acts on the colon, bisacodyl specifically stimulates the natural evacuation process in the lower region of the gastrointestinal tract. Therefore, bisacodyl is ineffective in altering the digestion or absorption of calories or essential nutrients in the small intestine. PHARMACOKINETICS Following either oral or rectal administration, bisacodyl is rapidly hydrolyzed to the active principle bis-(p-hydroxyphenyl)-pyridyl-2- methane (BHPM), mainly by esterases of the enteric mucosa. Administration as an enteric coated tablet was found to result in maximum BHPM plasma concentrations between 4 - 10 hours post administration whereas the laxative effect occurred between 6 - 12 hours post administration. In contrast, following the administration as a suppository, the laxative effect occurred on average approximately 20 minutes post administration; in some cases it occurred 45 minutes after administration. The maximum BHPM-plasma concentrations were achieved 0.5 - 3 hours following the administration as a suppository. Hence, the laxative effect of bisacodyl does not correlate with the plasma level of BHPM. Instead, BHPM acts locally in the lower part of the intestine and there is no relationship between the laxative effect and plasma levels of the active moiety. For this reason, bisacodyl coat קרא את המסמך השלם