5mg coated Tablet
5mg, 10mg Suppository
DRUG CATEGORY: Stimulant Laxative
BRAND NAME: Dulcolax®
Bisacodyl is a locally acting laxative from the diphenylmethane derivative group (4,4'-diacetoxy-diphenyl-(pyridyl-2)-methane).
As a contact laxative, Bisacodyl stimulates peristalsis of the colon and promotes accumulation of water in the colonic lumen which leads to stimulation of defecation, reduction of transit time and softening of stool.
Bisacodyl is indicated in patients suffering from constipation and for preparation of diagnostic procedures, in pre and post-operative treatment and in conditions which require defecation to be facilitated.
1 coated tablet contains 5mg of Bisacodyl
1 suppository contains 10mg of Bisacodyl
1 pediatric suppository contains 5 mg Bisacodyl
The laxative effect of Bisacodyl occurs upon contact with the colonic mucosa where it stimulates the sensory nerve endings that results to increase peristaltic contractions of the large intestines to produce soft well-formed stools. This results in a stimulation of defecation, reduction of transit time, and a softening of the stool. It is a reversible reaction wherein colonic function would return to its normal condition after defecation occurs.
The tablets usually exert a laxative effect within 6-12 hours after intake. The suppositories usually take effect in about 20 minutes (range 10 to 30 minutes); in some cases, it occurs 45 minutes after administration.
DOSAGE AND ADMINISTATION
Unless otherwise prescribe by the physician, the following dosages are recommended:
Adults and Children over 10 years old: 1 to 2 coated tablets (5 -10 mg) or 1 suppository (10 mg)
Children 4 – 10 years old: 1 coated tablet (5 mg) or 1 pediatric suppository (5mg)
Children under 4 years old: 1 pediatric suppository (5 mg)
Children should not take Bisacodyl without medical advice.
It is recommended to take the enteric coated tablets at night to promote 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.
Suppositories should be unwrapped and inserted into the rectum, pointed end first.
For preparation of diagnostic procedures, in pre- and post-operative treatment and in medical conditions which require defecation to be facilitated, Bisacodyl should be used under medical supervision.
Bisacodyl tablets should be combined with suppositories in order to achieve complete evacuation of the intestine.
Adults and Children over 10 years old: 2 – 4 tablets the night before and 1 adult suppository in the morning of the examination.
Children 4 – 10 years old: 1 tablet the night before and 1 pediatric suppository on the following morning.
CONTRAINDATIONS AND PRECAUTIONS
- Bisacodyl should not be given to patients with ileus, intestinal obstruction, acute abdominal conditions including appendicitis and acute inflammatory bowel disease and severe abdominal pain associated with nausea and vomiting which may be indicative of severe conditions.
- Bisacodyl is also contraindicated in severe dehydration and in patients with known hypersensitivity to Bisacodyl or any other component of the product.
- In cases of rare hereditary conditions that may be incompatible with an excipient of the product, the use of the product is contraindicated.
- As with all laxatives, Bisacodyl should not be taken on a continuous daily basis or for extended periods without investigating the cause of constipation.
- Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalemia.
- Intestinal loss of fluids can promote dehydration. Symptoms ma include thirst and oliguria. In patients suffering from fluid loss where dehydration may be harmful (e.g. renal insufficiency, elderly patients) Bisacodyl should be discontinued and only be restarted under medical supervision.
- Patients may experience hematochezia (blood in stool) that is generally mild and self-limiting.
- Dizziness and/or syncope have been reported in patients who have taken Bisacodyl. The details available for these cases suggest that the events would be consistent with defecation syncope (or syncope attributable to straining at stool), or with a vasovagal response to abdominal pain related to the constipation, and not necessarily to the administration of Bisacodyl.
- The use of suppositories may lead to painful sensations and local irritation, especially in anal fissure and ulcerative proctitis. Patients with rare hereditary conditions of galactose intolerance, e.g. galactosemia, and fructose intolerance should not take this medicine.
- No studies the effects of Bisacodyl on the ability to drive and use machines have been performed. However, patients should be advised that due to vasovagal response (e.g. to abdominal spasm) they may experience dizziness and/or syncope. If patients experience abdominal spasm, they should avoid potentially hazardous tasks such as driving or operating machinery.
The concomitant use of diuretic and adrenocorticosteroids may increase the risk of electrolyte imbalance if excessive doses of Bisacodyl are taken.
If so, electrolyte imbalance may increase the sensitivity to cardiac glycosides.
PREGNANCY AND LACTATION
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 drugs, Bisacodyl should be taken during pregnancy only on medical advice.
Bisacodyl can be used during breast-feeding. No studies on the effect on human fertility have been conducted.
ADVERSE DRUG REACTIONS
The most commonly reported adverse reactions during treatment with Bisacodyl are abdominal pain and diarrhea.
The following episodes may occure:
- 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 vasovagal response (e.g., to abdominal spasm, defecation).
- Gastrointestinal disorders: abdominal cramps, abdominal pain, diarrhea, nausea, hematochezia (blood in stool), vomiting, abdominal discomfort, anorectal discomfort, colitis.
High doses usually result to watery stools (diarrhea), abdominal cramps and clinically significant loss of fluid, potassium, and other electrolytes.
Bisacodyl, as with other laxatives, when taken in chronic overdose may cause chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, and renal calculi. Renal tubular damage, metabolic alkalosis, and muscle weakness secondary to hypokalemia have also been described in association with chronic laxative abuse. After ingestion of oral forms of Bisacodyl, absorption can be minimized or prevented by inducing vomiting or gastric lavage. Replacement of fluids and correction of electrolyte imbalance may be required. This is especially important in the elderly and the young. Administration of antispasmodic may be of value.
Store at temperatures not exceeding 30oC.