DULCOLAX FOR CHILDREN SUPPOSITORY 5 mg

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

BISACODYL

Tilgængelig fra:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC-kode:

A06AB02

Dosering:

5 mg

Lægemiddelform:

SUPPOSITORY

Sammensætning:

BISACODYL 5 mg

Indgivelsesvej:

RECTAL

Recept type:

General Sale List

Fremstillet af:

INSTITUTO DE ANGELI S.R.L. (IDAPH)

Autorisation status:

ACTIVE

Autorisation dato:

1989-04-28

Indlægsseddel

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

Produktets egenskaber

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