Bisacodyl

Pronunciation

Class: Cathartics and Laxatives
ATC Class: A06AB02
VA Class: GA209
CAS Number: 603-50-9
Brands: Alophen Pills, Bisac-Evac, Carter’s Little Pills, Correctol, Dulcolax, Feen-A-Mint, Fleet Bisacodyl, Bisacodyl Uniserts, Fleet Bisacodyl Enema, Dulcolax Bowel Prep Kit

Introduction

Bisacodyl, a diphenylmethane laxative, is a stimulant laxative.b c e

Uses for Bisacodyl

Constipation

Used as a stimulant laxative to relieve occasional constipation.a c e f g h i

Has a more pronounced laxative effect than mild laxatives (e.g., anthraquinones such as cascara sagrada [no longer commercially available in the US]) but less pronounced than the violent purgation produced by castor oil.c

Use of stimulant laxatives for simple constipation is seldom necessary or desirable.c

If a stimulant laxative is used, senna derivatives may be preferred.c

Used to treat constipation that occurs following prolonged bed rest or hospitalization.c

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Used to treat chronic constipation associated with opiate therapy.e

Because bisacodyl may be distributed into milk, other laxatives usually are preferred for postpartum constipation.c

Stimulant laxatives have been used to treat constipation resulting from diminished colonic motor response in geriatric patients but, because this type of constipation is frequently due to psychological or physical laxative dependence, the bulk-forming laxatives are preferred.c

Stimulant laxatives are used to treat constipation occurring secondary to idiopathic slowing of transit time, to constipating drugs, or to irritable bowel or spastic colon syndrome.c

Stimulant laxatives have been used to treat constipation in patients with neurologic constipation.c

Bowel Cleansing

Used orally and/or rectally (as suppositories or enemas) to empty the bowel prior to surgery or radiographic, proctoscopic, or endoscopic (e.g., sigmoidoscopic, proctoscopic) procedures, when thorough evacuation is essential.a c e Oral therapy often is supplemented with rectal evacuants.b c k j

Used orally or rectally as a laxative for postoperative, antepartum, or postpartum care.i

Enemas are used to cleanse the colon postoperatively.c i

Suppositories may be used to cleanse the colon in pregnant women prior to delivery if they are given at least 2 hours before onset of the second stage of labor.c

Usually supplemented with administration of rectal evacuants, such as saline, stimulant, or soapsuds enemas, immediately before radiographic procedures.c

Bisacodyl tannex is added to barium sulfate enemas to aid in coating the intestinal mucosa and enhance colonic evacuation prior to radiographic examination of the colon.c

Colostomy Flushing

Has been used to facilitate flushing of colostomies;c e may reduce or eliminate the need for irrigations.e

Bisacodyl Dosage and Administration

Administration

Administer orally as delayed-release (enteric-coated) tablets.a b f g i j k

Administer rectally as suspension enemas or as suppositories.b h i j k

Administered as a flush suspension for colostomies.c e

Oral Administration

Bisacodyl is administered orally.a b f g i

For occasional use as an oral laxative, administer the evening before a morning bowel movement is desired.b

To avoid gastric irritation and the possibility of vomiting, delayed-release (enteric-coated) tablets must be swallowed whole and not crushed, chewed, or taken within 1 hour of antacids or milk.a b e f g

Rectal Administration

Bisacodyl also is administered rectally as a suppository or enema.b h i j k

Remove the foil wrapper and insert the suppository well into the rectum, pointed end first, and retain for at least 15–20 minutes if possible.h j

Shake bisacodyl enemas well and remove the protective shield from the tip before inserting rectally.i Lie on left side with left knee slightly bent and the right leg drawn up or be in the knee-chest position and insert the enema tip into the rectum.i Squeeze the contents of the enema container into the rectum.j

Bisacodyl tannex is administered rectally as an enema.b

Rectal suppositories and enemas may be administered at the time a bowel movement is desired.b e h i

Dosage

Pediatric Patients

Constipation

Stimulant laxatives generally avoided in children <6 years of age for occasional constipation,c unless otherwise directed by a clinician.a f g h i

Oral

Children 3–11 years of age: A single 5- to 10-mg (usually 5-mg) or 0.3-mg/kg dose daily.a b f g

Children ≥12 years of age: A single 5- to 15-mg (usually 10-mg) dose daily.a b e f g

Rectal (enema)

Children ≥12 years of age: A single 10-mg (30-mL) dose daily.i

Rectal (suppositories)

Children <2 years of age: A single 5-mg (½ suppository) dose daily.b e

Children 2–11 years of age: A single 5- or 10-mg (½ or 1 suppository, respectively) dose daily.b e h

Children ≥12 years of age: A single 10-mg (1 suppository) dose daily.b e h

Adults

Constipation
Oral

Usually, 5–15 mg daily given as a single dose;a b f g some patients may require single daily doses up to 30 mg.e

Rectal (enema)

A single 10-mg (30-mL) dose daily.i

Rectal (suppositories)

A single 10-mg (1 suppository) dose daily.b e h

Bowel Cleansing

Up to 30 mg may be given orally when complete evacuation of the colon is required for special procedures.b

One of the following regimens can be used to clear the bowel prior to surgical, radiographic, or endoscopic procedures.j l m When available, provide patients with a copy of the manufacturers’ instructions, which detail the specific regimen to be employed.j l m n o p q

Bisacodyl Preparation for Barium Sulfate Enemas
Oral and Rectal

Give up to 30 mg of bisacodyl orally the night before the procedure, followed by a 10-mg bisacodyl rectal suppository 1–2 hours before the procedure.b Do not eat following administration of the tablets.b

Bisacodyl and Magnesium Citrate Preparatory Regimens
Oral and Rectal

Preparatory regimens using magnesium citrate, which acts mainly on the small intestine, in addition to administration of the usual oral (up to 30 mg) and rectal (10 mg) dose of bisacodyl also have been used.b

Bisacodyl Antepartum Preparation
Rectal (suppositories)

To cleanse the colon prior to delivery, a single 10-mg bisacodyl rectal suppository is administered at least 2 hours before onset of the second stage of labor.b

Bisacodyl Tannex Preparatory Enema
Enema

Bisacodyl tannex may be used prior to radiographic examinations or sigmoidoscopic or proctoscopic procedures.b

Give a residue-free diet the day before the procedure, followed by 30–60 mL of castor oil orally 16 hours before the examination or procedure.b

Prepare a cleansing enema by dissolving bisacodyl tannex equivalent to 1.5 mg of bisacodyl and 2.5 g of tannic acid (one packet of the commercially available bisacodyl tannex product) in 1 L of lukewarm water.b

When used as a radiopaque enema adjuvant, bisacodyl tannex equivalent to 1.5–3 mg of bisacodyl (1–2 packets of the commercially available product) is dissolved in 1 L of barium sulfate suspension.b The concentration of bisacodyl tannex should not exceed 0.5% (2 packets of the commercially available product per L).b

Administer the cleansing enema containing bisacodyl tannex the day of the procedure.b

If necessary, repeat the cleansing enema, but total dosage for one entire colonic examination (including the cleansing enema) should not exceed 4.5 mg of bisacodyl and 7.5 g of tannic acid (3 packets of the commercially available preparation), and no more than 6 mg of bisacodyl and 10 g of tannic acid (4 packets of the commercially available product) should be administered during a 72-hour period.b

Dulcolax Prep Kit
Oral and Rectal

The regimen begins with a liquid meal at a prescribed time, followed by periodic clear liquid intake throughout the day and scheduled administration of oral laxatives, and concluding with rectal administration of a bisacodyl suppository.k

In the usual regimen, 300 mL of magnesium citrate solution is administered orally at 4 p.m. the day before the procedure, followed by 20 mg of bisacodyl orally at 6 p.m. the day before the procedure, and concluding with a 10-mg bisacodyl rectal suppository at 5:30 a.m. the morning of the procedure.k

Special Populations

Hepatic Impairment

No specific dosage recommendations for bisacodyl in hepatic impairment.a b f g h i Minimally absorbed systemically following oral or rectal administration.b e

Renal Impairment

No specific dosage recommendations for bisacodyl in renal impairment.a b f g h i Minimally absorbed systemically following oral or rectal administration.b e

Geriatric Patients

No specific geriatric dosage recommendations for bisacodyl.a

Cautions for Bisacodyl

Contraindications

  • Acute abdominal pain, nausea, vomiting, or other symptoms of appendicitis or undiagnosed abdominal pain or rectal bleeding.c e

  • Intestinal obstruction.c

  • Bisacodyl tannex: Children <10 years of age.c

Warnings/Precautions

Warnings

Laxative Dependence

Habit-forming.c

Potentially serious toxicity with chronic use.c

Chronic Use or Overdosage

Chronic use or overdosage may produce persistent diarrhea, hypokalemia, loss of essential nutritional factors, and dehydration.c

Laxative dependence, chronic constipation, and loss of normal bowel function could occur during long-term use.c

Factitious diarrhea (i.e., severe, chronic, watery diarrhea, frequently occurring at night and accompanied by abdominal pain, weight loss, nausea, and vomiting).e

Electrolyte disturbances including hypokalemia, hypocalcemia, metabolic acidosis or alkalosis, abdominal pain, diarrhea, malabsorption, weight loss, and protein-losing enteropathy may occur.c May require immediate medical intervention with appropriate fluid and electrolyte replacement.j

Electrolyte disturbances may produce vomiting and muscle weakness; rarely, osteomalacia, secondary aldosteronism, and tetany may occur.c

Pathologic changes including structural damage to the myenteric plexus, severe and permanent interference with colonic motility, and hypertrophy of the muscularis mucosae may occur with chronic use.c

Protein-losing enteropathy and steatorrhea can occur.e

“Cathartic colon” with atony and dilation of the colon, especially of the right side, has occurred with habitual use (often for several years) and often resembles ulcerative colitis.c

General Precautions

Rectal Administration

Some clinicians state that stimulant laxative suppositories or enemas should not be used in patients with abdominal cramps, anal or rectal fissures, or ulcerated hemorrhoids.c

Bisacodyl Tannex

Hepatotoxicity may result if sufficient tannic acid is absorbed from bisacodyl tannex laxatives.c

Bisacodyl tannex should be used with caution, if at all, in patients receiving multiple enemas or in those with extensive ulceration of the colon since increased tannic acid absorption may occur.c

Use of Fixed Combination

When used in regimens with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Bisacodyl (base): Category B.e Bisacodyl tannex: Safety not established.c

Lactation

May be distributed into the milk of nursing women but usually in amounts insufficient to produce a laxative effect.b c e

Pediatric Use

Stimulant laxatives generally avoided in children <6 years of age for occasional constipation,c unless otherwise directed by a clinician.a f g h i

Do not use bisacodyl enemas in children <12 years of age.i

Bisacodyl tannex: Because the possibility of tannic acid absorption has not been studied adequately in children <10 years of age, bisacodyl tannex is contraindicated in this age group.c

Common Adverse Effects

Some degree of abdominal discomfort, nausea, cramps, griping, and/or faintness with therapeutic doses.c

Diarrhea, GI irritation, and fluid and electrolyte depletion.c

Gastric irritation and the possibility of vomiting if enteric coating of tablets is disrupted.b (See Advice to Patients.)

Rectal administration of bisacodyl suspensions or suppositories may cause irritation and a sensation of burning of the rectal mucosa and mild proctitis.c e

Hepatotoxicity if sufficient tannic acid is absorbed from bisacodyl tannex.c

Interactions for Bisacodyl

GI Drug Absorption

By increasing intestinal motility, can potentially decrease transit time of concomitantly administered oral drugs and thereby decrease their absorption.c

Specific Drugs and Foods

Drug or Food

Interaction

Comments

Antacids

Administration of delayed-release (enteric-coated) tablets within 1 hour of antacids results in rapid erosion of the coatingb e

Do not take within 1 hour of antacids since gastric or duodenal irritation can occurb e

Cimetidine

Administration of delayed-release (enteric-coated) tablets within 1 hour of cimetidine results in rapid erosion of the coatingb e

Do not take within 1 hour of cimetidine since gastric or duodenal irritation can occurb e

Milk

Administration of delayed-release (enteric-coated) tablets within 1 hour of milk results in rapid erosion of the coatingb e

Do not take within 1 hour of milk since gastric or duodenal irritation can occurb e

Famotidine

Administration of delayed-release (enteric-coated) tablets within 1 hour of famotidine results in rapid erosion of the coatingb e

Do not take within 1 hour of famotidine since gastric or duodenal irritation can occurb e

Proton-pump inhibitors

Increased gastric pH results in rapid erosion of the coating of delayed-release (enteric-coated) tabletse

Gastric or duodenal irritation can occure

Ranitidine

Administration of delayed-release (enteric-coated) tablets within 1 hour of ranitidine results in rapid erosion of the enteric coatingb e

Do not take within 1 hour of ranitidine since gastric or duodenal irritation can occurb e

Bisacodyl Pharmacokinetics

Absorption

Bioavailability

Absorption of bisacodyl or bisacodyl tannex is minimal following oral or rectal administration.b e

Tannic acid may be absorbed following rectal administration; very little is known about the degree of absorption and circumstances under which absorption may occur with bisacodyl tannex.b

Onset

Oral therapeutic dosages: evacuation is produced in 6–8 hours (range: 6–12 hours).a b e f g i

Rectally administered bisacodyl or bisacodyl tannex produces evacuation of the colon within 15 minutes to 1 hour.b e h i

Distribution

Extent

Distributes into milk.

Plasma Protein Binding

>99%.

Special Populations

In patients with renal impairment, possible altered protein binding and pharmacokinetics.

Elimination

Metabolism

Any bisacodyl that is absorbed is metabolized in the liver.b

Elimination Route

Any bisacodyl that is absorbed is excreted in the urine.b

Stability

Storage

Bisacodyl rectal suppositories and enteric-coated tablets should be stored at less than 30°C.b Reconstituted solutions of bisacodyl tannex should be used immediately following preparation.b

Oral

Tablets, Delayed-release (enteric-coated)

In well-closed containers at ≤30°C.b d

Rectal

Suppositories

In well-closed containers at ≤30°C.b d

Suspension

In unit-dose containers at ≤30°C.b d

Actions

  • Bisacodyl and bisacodyl tannex are diphenylmethane-derivative stimulant laxatives.b c e

  • Commonly thought that stimulant laxatives induce defecation by stimulating propulsive peristaltic activity of the intestine through local irritation of the mucosa or through a more selective action on the intramural nerve plexus of intestinal smooth muscle, thus increasing motility.c e

  • More recent evidence shows that stimulant laxatives alter fluid and electrolyte absorption, producing net intestinal fluid accumulation and laxation.c

  • Stimulant laxatives mainly promote evacuation of the colon;c action of bisacodyl on small intestine is negligible.e

  • Bisacodyl acts in the colon on contact with the mucosal nerve plexus.e

    Colonic stimulation is segmented and axonal, producing contraction of the entire colon.e

  • Action is independent of intestinal tone.e

  • Tannic acid present in the bisacodyl tannex complex precipitates protein and its astringent effect decreases mucus secretion in the large intestine.c

    Tannic acid also reportedly facilitates adherence of contrast media to mucous membranes, but this is disputed by some clinicians.c

    Some reports that tannic acid increases evacuation of the colon, but other reports that its astringent effect produces constipation.c

Advice to Patients

  • Importance of swallowing delayed-release (enteric-coated) tablets whole and of not crushing, chewing, or taking within 1 hour of antacids or milk so that gastric irritation and the possibility of vomiting are avoided.a b f g h i

    Patients who cannot swallow without chewing should not use the delayed-release (enteric-coated) tablets,f g unless otherwise directed by a clinician.g

  • Advise patients that prolonged use can cause excessive loss of fluids, electrolytes, and nutrients.e

  • Importance of not using laxative products for a period longer than 1 week unless directed by a clinician.a c f g h i

  • Importance of informing clinicians before use if abdominal pain, nausea, or vomiting is present or if a sudden change in bowel habits that persists over a period of 2 weeks has been noticed.a c f g h i

  • Importance of contacting a clinician if a bowel movement does not occura f g h i j within 12 hoursa or if rectal bleeding occurs since these may be signs of a serious condition.a f g h i j

  • Advise patient to open and read directions for bowel cleansing preparations at least 2 days in advance of examination.j s t Importance of following complete regimen for bowel cleansing preparations.m o r s t

  • Importance of adequate oral fluid intake when used for bowel cleansing.j k l m n o p q

  • Advise about risk of laxative abuse and potential serious consequences.c e (See Chronic Use or Overdosage under Cautions.)

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.c e i

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Bisacodyl

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, delayed-release (enteric-coated)

5 mg*

Alophen Pills

Numark

Bisac-Evac

G&W

Bisacodyl Enteric-coated Tablets

Carter’s Little Pills

Carter

Correctol Caplets

Schering-Plough

Correctol Tablets

Schering-Plough

Dulcolax

Novartis

Feen-A-Mint

Schering-Plough

Fleet Bisacodyl

Fleet

Rectal

Suppositories

10 mg*

Bisac-Evac

G&W

Bisacodyl Suppositories

Bisacodyl Uniserts

Upsher-Smith

Dulcolax

Novartis

Fleet Bisacodyl

Fleet

Suspension

10 mg/30 mL

Fleet Bisacodyl Enema

Fleet

Bisacodyl Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Kit

4 Tablets, enteric-coated, Bisacodyl 5 mg (Dulcolax)

1 Suppository, rectal, Bisacodyl 10 mg (Dulcolax)

Dulcolax Bowel Prep Kit

Novartis

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Bisac-Evac 10MG Suppositories (G &amp; W LABS): 100/$18.97 or 300/$56.91

Bisacodyl 10MG Suppositories (PERRIGO): 100/$25.99 or 300/$65.97

Dulcolax 5MG Enteric-coated Tablets (BOEHRINGER INGELHEIM CONSUMER): 10/$13.99 or 30/$20.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions October 1, 2014. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

100. Food and Drug Administration. Laxative drug products for over-the-counter human use. 21 CFR Part 310. Final rule. [Docket No. 78N-036L.] Fed Regist. 1999; 64:4535-40.

a. Boehringer Ingelheim. Dulcolax (bisacodyl USP) tablets laxative prescribing information. Ridgefield, CT; 2002.

b. AHFS drug information 2004. McEvoy GK, ed. Diphenylmethane laxatives. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2775-7.

c. AHFS Drug Information 2004. McEvoy GK, ed. Cathartics and laxatives general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2769-73

d. The United States pharmacopeia, 27th rev, and The national formulary, 22nd ed. Rockville, MD: The United States Pharmacopeial Convention, Inc; 2004:250-2.

e. American Pharmaceutical Association. Handbook of nonprescription drugs. 14th ed. Washington, DC: American Pharmaceutical Association; 2004:380,384-6,1338.

f. Novartis Consumer Health, Inc. Ex-Lax Ultra Stimulant Laxative (bisacodyl) tablets prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2004. Updated 2003.

g. Purdue Frederick. Gentlax (bisacodyl) tablets prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2004. Updated 2002.

h. Boehringer Ingelheim. Dulcolax (bisacodyl) suppositories prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2004. Updated 2002.

i. CB Fleet Co. Fleet Bisacodyl Laxatives (bisacodyl) enema, suppositories, and tablets prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2004. (undated)

j. CB Fleet Co. Fleet prep kits prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2007. Updated 2006.

k. Boehringer Ingelheim. Dulcolax Bowel Prep Kit (bisacodyl) kit prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2004. (undated)

l. G&W Laboratories Inc. Evac-Q-Kwik (bisacodyl) bowel cleansing system patient instruction sheet. Plainsboro, NJ: 1997 Aug.

m. E-Z-EM, Inc. LoSo Prep magnesium carbonate, citric acid, and potassium citrate for oral solution, bisacodyl tablets [enteric coated] USP, bisacodyl suppository USP) bowel cleansing system patient information. Westbury, NY; 2004 Feb.

n. EZ-EM, Inc. LiquiPrep (bisacodyl) bowel evacuant kit patient information. Westbury, NY; 1994 Oct.

o. Lafayette Pharmaceuticals Inc. Tridrate (magnesium citrate oral solution USP, bisacodyl tablets USP, bisacodyl suppository USP) bowel evacuant kit prescribing information. Lafayette, IN; 1992 Nov.

p. Lafayette Pharmaceuticals Inc. Tridrate Dry Bowel Cleansing System patient information. Lafayette, IN. Undated.

q. Purdue Frederick. X-Prep (bisacodyl) Bowel Evacuant Kit patient information. Norwalk, CT; 1999.

r. E-Z-EM, Inc. Liquid LoSo Prep (magnesium citrate oral solution USP, bisacodyl tablets [enteric coated] USP, bisacodyl suppository USP) bowel cleansing system patient information. Westbury, NY; 2004 Oct.

s. CB Fleet Company, Inc. Fleet Prep Kit 1 patient information. Lynchburg, VA. Undated.

t. CB Fleet Company, Inc. Fleet Prep Kit 3 patient information. Lynchburg, VA. Undated.

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