Bisacodyl

Registered South African conditions:

• Relief of occasional constipation

Contraindications 

• Hypersensitivity to the active ingredient or any of its excipients
• Ileus
• Intestinal obstruction
• Acute abdominal conditions
• Appendicitis
• Acute inflammatory bowel diseases
• Severe abdominal pain associated with nausea and vomiting
• Severe dehydration
• Anal fissures (sup)
• Ulcerative proctitis with mucosal damage (sup)
• Galactose intolerance (tab)
• Lapp lactase deficiency (tab)
• Glucose-galactose malabsorption (tab)
• Fructose intolerance (tab)
• Sucrase-isomaltase insufficiency (tab)

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Elderly
• Children
• Colonic mucosal ischaemia
• Fluid loss
• Prolonged use
• Overuse,
• Worsening of symptoms during use of bisacodyl
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: sup, tab

Dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Relief of occasional constipation

• Oral (tab): 5-15mg, dly at night as a single dose
• Rectal (sup): 10mg, dly as a single dose

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See additional prescribing points for administration directions

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Indications and dosages registered in other jurisdictions

Short term relief of occasional constipation

• Oral (tab): 5-10mg, dly
• Rectal (sup): 10mg, dly for immediate effect

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The maximum daily dose should not be exceeded. In the management of constipation once regularity has been restarted, the dosage should be reduced and can usually be stopped

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See additional prescribing points for administration directions

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Preparation of diagnostic procedures and pre- and postoperatively
- When defaecation needs to be facilitated

• Oral (tab): Initial: 10mg, 12hrly for one day; Then: Rectal (sup): 10mg, as a single dose the following morning

Paed. forms avail. in SA and covered in this monograph: sup, tab

Dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Relief of occasional constipation

Oral (tab)

• Younger than 6 years: Not recommended for use
• Between 6-12 years: 5mg, dly at night as a single dose
• Older than 12 years: See adult dosage

Rectal (sup)

• Younger than 1 year: No information available
• Between 1-12 years: 5mg, dly as a single dose
• Older than 12 years: See adult dosage

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See additional prescribing points for administration directions

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Indications and dosages registered in other jurisdictions

Short term relief of occasional constipation
- Chronic, or constipation of recent onset where a stimulant laxative is required

Rectal (sup)

• Younger than 4 years: Not established for use
• Between 4-10 years: 5mg, dly for immediate effect
• Older than 10 years: See adult dosage

Oral (tab)

• Not established for use in children below 18 years

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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. In the management of constipation, once regularity has been restarted dosage should be reduced and can usually be stopped

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

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See additional prescribing points for administration directions

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Preparation of diagnostic procedures and pre- and postoperatively
- When defaecation needs to be facilitated

Oral (tab); Rectal (sup)

• Younger than 4 years: Not established for use
• Between 4-10 years: Oral (tab): Initial: 5mg, as a single dose at night; Then: Rectal (sup): 5mg, as a single dose the following morning
• 10 years and older: See adult dosage

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See additional prescribing points for administration directions

Pregnancy

• Caution
• There are no adequate and well-controlled studies in pregnant women. Long experience has shown no evidence of undesirable or damaging effects during pregnancy
• Nevertheless, as with all medicines, Bisacodyl should not be taken in pregnancy, especially the first trimester, unless the expected benefit is thought to outweigh any possible risk and only on medical advice

Breastfeeding

• Caution
• Clinical data show that neither the active moiety of bisacodyl (BHPM or bis-(p-hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into the milk of healthy breastfeeding females. Nevertheless, as with all medicines, Bisacodyl should not be taken and during breastfeeding unless the expected benefit is thought to outweigh any possible risk and only on medical advice

Fertility

• No studies on the effect on human fertility have been conducted

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dizziness  
• Syncope
• Vasovagal response

Endocrine and Metabolic Disorders

• Dehydration

Gastrointestinal Disorders

• Haematochezia  
• Nausea and vomiting
• Abdominal discomfort
• Anorectal discomfort
• Abdominal cramps
• Abdominal pain
• Diarrhoea  
• Colitis
• Ischaemic colitis
• Abdominal spasm
• Defaecation

Immune, Blood and Lymphatic System Disorders

• Anaphylactic reactions
• Angioedema
• Hypersensitivity

• Antacids (tab)
• Milk products  (tab)
• Other laxatives (tab)
• Proton pump inhibitors (tab)
• Diuretics
• Adrenocorticosteroids 
• Cardiac glycosides

None routine

Suppository 10mg - EML (Hospital)

Tablet 5mg - NON-EML 

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Prolonged use

• Long-term use of stimulant laxatives should be avoided, as use for more than a brief period of treatment may lead to impaired function of the intestine and dependence on laxatives. If laxatives are needed every day the cause of the constipation should be investigated
• This product should only be used if a therapeutic effect cannot be achieved by a change of diet or the administration of bulk forming agents

Bisacodyl and weight loss

• Stimulant laxatives including bisacodyl DO NOT help with weight loss
• They do not reduce the absorption of calories or nutrients
• They can cause watery stools (diarrhoea), abdominal cramps and dehydration. Dehydration can seem like weight loss

Administration directions

South African registered indications and dosages

Oral (tab)

• The tablets should be swallowed whole with adequate fluid; with a bowel movement generally produced within 6 to 12 hours
• Bisacodyl tablets should not be taken within one hour after taking an antacid or milk

Rectal (sup)

• The suppositories should be unwrapped and inserted into the rectum pointed end first, with a bowel movement generally produced within 15 minutes to one hour

Indications and dosages registered in other jurisdictions

Oral (tab)

• Bisacodyl tablets should be swallowed whole with an adequate amount of fluid
• The coated tablets should not be taken together with products which reduce the acidity of the upper gastrointestinal tract, such as milk, antacids or proton pump inhibitors, in order not to prematurely dissolve the enteric coating

Rectal (sup)

• Suppositories are usually effective in about 20 minutes (usual range 10-30 minutes). Rarely the laxative effect has been reported 45 minutes after administration. They should be unwrapped and inserted into the rectum pointed end first

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

Bisacodyl is available in several formulations. Please note the list below gives examples of products which are available and is not necessarily comprehensive. The listing of a product does not constitute endorsement of the product by EMGuidance; likewise, failure to list a product does not imply that EMGuidance disapproves of the product. This information is put together on the basis of the National Government's Medicines Price Registry at the time of publication

Tablet 5mg

• Dulcolax (Ingelheim)
• Freshen (Adcock)

Suppository 5mg

• Dulcolax (Ingelheim)

Suppository 10mg

• Dulcolax (Ingelheim)