1. Name Of The Medicinal Product
Bisacodyl Tablets 5mg
2. Qualitative And Quantitative Composition
Each tablet contains bisacodyl BP 5mg
3. Pharmaceutical Form
Enteric coated tablet
4. Clinical Particulars
4.1 Therapeutic Indications
For short-term use for constipation, whenever a stimulant laxative is required.
Bowel clearance before surgery, labour or radiological examination, all of which should be under medical supervision.
4.2 Posology And Method Of Administration
In constipation:
Adults and children over 10 years old: 2 tablets (10mg) at night; occasionally a higher dosage is required, and up to 3 or 4 tablets (15mg to 20mg) may be given.
Elderly: As for adults. It may be necessary to reduce the dosage under certain circumstances.
Children 3 to 10 years old: 1 tablet (5mg) at night.
Children under 3 years old: Not recommended.
Before surgery, labour or hospital radiological examination:
Adults and children over 10 years old: 2 tablets (10mg) on each of 2 nights before the anticipated procedure.
Elderly: As for adults. It may be necessary to reduce the dosage under certain circumstances.
Children 3 to 10 years old: 1 tablet (5mg) on each of 2 nights before the investigation.
Children under 3 years old: Not recommended.
Method of administration: oral.
4.3 Contraindications
Intestinal obstruction, ileus and those where a contact laxative is contra-indicated.
4.4 Special Warnings And Precautions For Use
If laxatives are needed every day, the cause of constipation should be investigated.
Excessive and prolonged use is dangerous and may result in diarrhoea or rebound constipation leading to electrolyte imbalance and may precipitate the onset of an atonic non-functioning colon and hypokalaemia.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Antacids or milk products may affect the absorption of bisacodyl.
Concomitant use with diuretics may increase the loss of electrolytes, particularly potassium, causing increased toxicity of cardioglycosides.
4.6 Pregnancy And Lactation
No evidence of ill-consequence in humans and no hazards shown in animal studies. Usual precautions, particularly in the first trimester of pregnancy, should be taken.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
As with any effective laxative, griping has occasionally been reported. Other effects include severe colic and diarrhoea.
4.9 Overdose
Colicky lower abdominal pain with possible signs of dehydration may be expected, particularly in the elderly and the very young. Gastric lavage should be performed where appropriate. Adequate hydration must be maintained and the serum potassium should be measured. Antispasmodics may be of some value. Particular care should be taken regarding fluid balance, particularly in the elderly and the very young.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
In common with other stimulant laxatives, bisacodyl (which is of a related structure to phenolphthalein) stimulates accumulation of water and electrolytes in the colonic lumen and enhances intestinal motility.
It may stimulate sodium/potassium-ATPase which may account for a portion of its laxative activity.
It may also increase the synthesis of prostaglandins and cyclic-AMP, and this may contribute to increased secretion of water and electrolytes.
5.2 Pharmacokinetic Properties
Bisacodyl is rapidly converted by intestinal and bacterial enzymes to its desacetyl metabolite.
As much as 5% of an oral dose is absorbed and excreted in the urine as the glucuronide. This inactive metabolite is also excreted in the bile and may be hydrolised to active drug in the colon.
5.3 Preclinical Safety Data
There are no preclinical safety data of relevance to the prescriber.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lactose monohydrate, maize starch, liquid paraffin, magnesium stearate, Opaseal (alcohol, polyvinyl acetate phthalate, purified water, ethyl acetate and stearic acid), sucrose, titanium dioxide (E171) and tartrazine lake (E102), talc, povidone K30, kaolin light, beeswax, carnuba wax and shellac.
6.2 Incompatibilities
Not known.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Store in a cool dry place.
6.5 Nature And Contents Of Container
Securitainers, pack sizes 500 and 1,000.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Sandoz Ltd
Woolmer Way
Bordon
Hampshire
GU35 9QE
8. Marketing Authorisation Number(S)
PL 4416/0206
9. Date Of First Authorisation/Renewal Of The Authorisation
19 June 1992
10. Date Of Revision Of The Text
February 2007
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