DULCOLAX TABLET 5 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Bisacodyl

Available from:

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

ATC code:

A06AB02

Dosage:

5.0000mg

Pharmaceutical form:

ENTERIC COATED TABLET

Composition:

Bisacodyl 5.0000mg

Administration route:

ORAL

Prescription type:

General Sale List

Manufactured by:

Delpharm Reims

Authorization status:

ACTIVE

Authorization date:

1989-04-28

Patient Information leaflet

 
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

Summary of Product characteristics

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