País: Cingapura
Língua: inglês
Origem: HSA (Health Sciences Authority)
BISACODYL
OPELLA HEALTHCARE SINGAPORE PTE. LTD.
A06AB02
10 mg
SUPPOSITORY
BISACODYL 10 mg
RECTAL
General Sale List
Istituto De Angeli S.r.l.
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 Leia o documento completo
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. PHARMACOLOGICAL PROPERTIES ATC code: A06AB02 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. 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 adminis Leia o documento completo