国家: 新加坡
语言: 英文
来源: HSA (Health Sciences Authority)
BISACODYL
SANOFI-AVENTIS SINGAPORE PTE. LTD.
A06AB02
5 mg
SUPPOSITORY
BISACODYL 5 mg
RECTAL
General Sale List
INSTITUTO DE ANGELI S.R.L. (IDAPH)
ACTIVE
1989-04-28
P a g e | 1 DULCOLAX ® abcd SUPPOSITORIES COMPOSITION 1 paediatric suppository contains 5 mg 1 suppository contains 10 mg 4,4’-diacetoxy-diphenyl-(pyridyl-2)-methane (= bisacodyl) PRODUCT DESCRIPTIONS Dulcolax Suppositories 5mg for children: Smooth, white, torpedo-shaped suppositories with a ‘chimney’ in the base. Dulcolax Suppositories 10mg for adults: White or slightly yellowish, torpedo-shaped suppositories with a smooth or slightly unctuous surface and a “chimney” in the base. PROPERTIES Bisacodyl is a locally acting laxative from the diphenylmethane derivatives group having a dual action. As a contact laxative, for which also antiresorptive hydragogue effects have been described, bisacodyl stimulates after hydrolysis in the large intestine, the mucosa of both the large intestine and of the rectum. Stimulation of the mucosa of the large intestine results in colonic peristalsis with promotion of 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. Stimulation of the rectum causes increased motility and a feeling of rectal fullness. The rectal effect may help to restore the “call to stool” although its clinical relevance remains to be established. 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 th 阅读完整的文件
P a g e | 1 DULCOLAX ® SUPPOSITORIES COMPOSITION 1 paediatric suppository contains 5 mg 1 suppository contains 10 mg 4,4’-diacetoxy-diphenyl-(pyridyl-2)-methane (= bisacodyl) PRODUCT DESCRIPTIONS Dulcolax Suppositories 5mg for children: Smooth, white, torpedo-shaped suppositories with a ‘chimney’ in the base. Dulcolax Suppositories 10mg for adults: White or slightly yellowish, torpedo-shaped suppositories with a smooth or slightly unctuous surface and a “chimney” in the base. PROPERTIES Bisacodyl is a locally acting laxative from the diphenylmethane derivatives group having a dual action. As a contact laxative, for which also antiresorptive hydragogue effects have been described, bisacodyl stimulates after hydrolysis in the large intestine, the mucosa of both the large intestine and of the rectum. Stimulation of the mucosa of the large intestine results in colonic peristalsis with promotion of 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. Stimulation of the rectum causes increased motility and a feeling of rectal fullness. The rectal effect may help to restore the “call to stool” although its clinical relevance remains to be established. 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 supposit 阅读完整的文件