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Dulcolax

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 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 coated tablets are formulated to be resistant to gastric and small intestinal juice. This results in a main release of the drug in the colon, which is the desired site of action.

After oral and rectal administration, only small amounts of the drug are absorbed and are almost completely conjugated in the intestinal wall and the liver to form the inactive BHPM glucuronide. The plasma elimination half-life of BHPM glucuronide was estimated to be approximately 16.5 hours. Following the administration of bisacodyl coated tablets, an average of 51.8% of the dose was recovered in the faeces as free BHPM and an average of 10.5% of the dose was recovered in the urine as BHPM glucuronide. Following the administration as a suppository, an average of 3.1% of the dose was recovered as BHPM glucuronide in the urine. Stool contained large amounts of BHPM (90% of the total excretion) in addition to small amounts of unchanged bisacodyl.

Indications
For use in patients suffering from constipation.
For preparation of diagnostic procedures, in pre- and postoperative treatment and in conditions, which require defecation to be facilitated.

Dosage and Administration
Unless otherwise prescribed by the physician, the following dosages are recommended:

For constipation
Adults: 1 - 2 coated tablets (5 -10 mg) daily
It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum recommended dose to produce regular stools. The maximum daily dose should not be exceeded.

Paediatric population:
Children > 10 years: 1 - 2 coated tablets (5 -10 mg) daily
It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum recommended dose to produce regular stools. The maximum daily dose should not be exceeded.

Children 4 - 10 years: 1 coated tablet (5 mg) daily
Children under 4 years: paediatric suppositories are recommended

The maximum daily dose should not be exceeded.

Children aged 10 years or younger with chronic or persistent constipation should only be treated under the guidance of a physician.

Instructions for use:
It is recommended to take the coated tablets at night to have a bowel movement the following morning. They should be swallowed whole with an adequate amount of fluid. The coated tablets should not be taken together with products reducing the acidity of the upper gastrointestinal tract, such as milk, antacids or proton pump inhibitors, in order not to prematurely dissolve the enteric coating.

For preparation for diagnostic procedures and preoperatively
For preparation of diagnostic procedures, in pre- and postoperative treatment and in medical conditions which require defecation to be facilitated, DULCOLAX should be used under medical supervision.

In order to achieve complete evacuation of the intestine the DULCOLAX dosage recommended for adults is two to four coated tablets the night before the examination, followed by one suppository in the morning of the examination.

Paediatric population:
For children 4 years of age and over, one coated tablet in the evening and one paediatric suppository on the following morning is recommended.

Side effects
The most commonly reported adverse reactions during treatment are abdominal pain and diarrhoea.

Immune system disorders
Anaphylactic reactions, angioedema, hypersensitivity.

Metabolism and nutrition disorders
Dehydration.
Nervous system disorders
Dizziness, syncope.
Dizziness and syncope occurring after taking bisacodyl appear to be consistent with a vasovagal response (e.g., to abdominal spasm, defecation).

Gastrointestinal disorders
Abdominal cramps, abdominal pain, diarrhoea, nausea, haematochezia (blood in stool), vomiting, abdominal discomfort, anorectal discomfort, colitis.

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