BISACODYL
DESCRIPTION:
Dulcolax is a contact stimulant laxative, administered either orally or
rectally, which acts directly on the colonic mucosa to produce normal
peristalsis throughout the large intestine. The active ingredient in Dulcolax,
bisacodyl, is a colorless, tasteless compound that is practically insoluble in
water or alkaline solution. Its chemical name is: bis(p- acetoxyphenyl)-2-
pyridylmethane. Bisacodyl is very poorly absorbed, if at all, in the small
intestine following oral administration, or in the large intestine following
rectal administration. On contact with the mucosa or submucosal plexi of the
large intestine, bisacodyl stimulates sensory nerve endings to produce
parasympathetic reflexes resulting in increased peristaltic contractions of the
colon. It has also been shown to promote fluid and ion accumulation in the
colon, which increases the laxative effect. A bowel movement is usually produced
approximately 6 hours after oral administration (8-12 hours if taken at
bedtime), and approximately 15 minutes to 1 hour after rectal administration,
providing satisfactory cleansing of the bowel which may, under certain
circumstances, obviate the need for colonic irrigation.
Dulcolax (brand of bisacodyl USP) is available as enteric coated tablets of 5 mg
each or as suppositories of 10 mg each. Each tablet also contains: acacia,
acetylated monoglyceride, carnauba wax, cellulose acetate phthalate, corn
starch, D&C Red No. 30 aluminum lake, D&C Yellow No. 10 aluminum lake, dibutyl
phthalate, docusate sodium, gelatin, glycerin, iron oxides, kaolin, lactose,
magnesium stearate, methylparaben, pharmaceutical glaze, polyethylene glycol,
povidone, propylparaben, sodium benzoate, sorbitan monooleate, sucrose, talc,
titanium dioxide, and white wax. Each suppository also contains hydrogenated
vegetable oil. Tablets and suppositories contain less than 0.2 mg sodium per
dosage unit and are thus dietetically sodium- free.
ACTIONS/CLINICAL PHARMACOLOGY:
SEE DESCRIPTION
INDICATIONS AND USAGE:
For the relief of occasional constipation and irregularity. For use as part of a
bowel cleansing regimen in preparing the patient for surgery or for preparing
the colon for x-ray endoscopic examination. Dulcolax will not replace the
colonic irrigations usually given patients before intracolonic surgery, but is
useful in the preliminary emptying of the colon prior to those procedures.
Dulcolax may also be used in postoperative care (i.e., restoration of normal
bowel hygiene), antepartum care, postpartum care, and in preparation for
delivery.
CONTRAINDICATIONS:
Stimulant laxatives, such as Dulcolax, are contraindicated for patients with
acute surgical abdomen, appendicitis, rectal bleeding, gastroenteritis, or
intestinal obstruction.
WARNINGS:
WARNINGS AND PRECAUTIONS
Use of Dulcolax is not recommended when abdominal pain, nausea, or vomiting are
present. Long term administration of Dulcolax is not recommended in the
treatment of chronic constipation. This product should not be used beyond 7 days
unless deemed necessary. Rectal bleeding or failure to have a bowel movement
after Dulcolax use may indicate a serious condition. If this occurs, the patient
should discontinue use of the product.
This and all medication should be kept out of the reach of children.
Pregnancy Category B
Teratology
Reproduction studies of oral doses of Dulcolax (bisacodyl) have been performed
in rats administered up to 70 times the human dose, and have revealed no
evidence of impaired fertility or damage to the fetus. At the dose which equated
to 70 times the human dose, there was some evidence of lower litter survival at
weaning. There are, however, no adequate and well- controlled studies in
pregnant women, hence Dulcolax should be used during pregnancy only at the
discretion of the physician.
Extent Of Drug Absorption
In a pharmacokinetic (crossover) study involving 12 patients (Roth, 1988),
plasma levels of bisacodyl were measured following oral administration of a 10
mg reference solution and two 5 mg Dulcolax tablets, and following rectal
administration of one 10 mg Dulcolax suppository. With the solution dose, the
average Cmax was 237 ng/ml; with the tablet dose, the average Cmax was 26 ng/ml
(11% of the solution Cmax); with the suppository dose, in six patients the
plasma level was below the limit of detection, and in the remaining six
patients, the average Cmax was 31 ng/ml (13% of the solution Cmax in those
particular patients). These data demonstrate the low level of systemic
absorption of bisacodyl resulting from Dulcolax use.
PRECAUTIONS:
See WARNINGS
ADVERSE REACTIONS:
ADVERSE DRUG REACTIONS
The process of restoring normal bowel function by use of a laxative may result
in some abdominal discomfort.
OVERDOSAGE:
There are no specific antidotes that are required to be administered in the
event of overdosage; however, supportive care may be required in order to
prevent dehydration and/or electrolyte imbalance.
DOSAGE AND ADMINISTRATION:
Tablets
Adults and children 12 years of age and over: Take 2 or 3 tablets (usually 2) in
a single dose once daily.
Children 6 to under 12 years of age: Take 1 tablet once daily.
Expect results in 8-12 hours if taken at bedtime or within 6 hours if taken
before breakfast. Do not chew or crush tablets. Do not administer tablets within
1 hour after taking an antacid or milk.
Children under 6 years of age: Oral administration is not recommended due to the
requirement to swallow tablets whole.
Suppositories
Adults and children 12 years of age and over: Use 1 suppository once daily.
Remove foil wrapper. Lie on your side and, with pointed end first, push
suppository high into the rectum so it will not slip out. Retain it for 15 to 20
minutes. If you feel the suppository must come out immediately, it was not
inserted high enough and should be pushed higher.
Children under 12 years of age: One half of one 10 mg suppository once daily.
If the suppository seems soft, hold in foil wrapper under cold water for one or
two minutes. In the presence of anal fissures or hemorrhoids, suppository may be
coated at the tip with petroleum jelly before insertion.
Preparation for x-ray endoscopy: For barium enemas, no food should be given
following oral administration to prevent reaccumulation of material in the
rectum, and a suppository should be administered one to two hours prior to
examination.
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