DULCOLAX SUPPOSITORY 10 mg

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Compre agora

Ingredientes ativos:

BISACODYL

Disponível em:

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

Código ATC:

A06AB02

Dosagem:

10 mg

Forma farmacêutica:

SUPPOSITORY

Composição:

BISACODYL 10 mg

Via de administração:

RECTAL

Tipo de prescrição:

General Sale List

Fabricado por:

Istituto De Angeli S.r.l.

Status de autorização:

ACTIVE

Data de autorização:

1989-04-28

Folheto informativo - Bula

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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
                                
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Características técnicas

                                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
                                
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