Bisacodyl

Bisacodyl
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

Disclaimer

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Bisacodyl is a gastrointestinal agent, laxative and stimulant that is FDA approved for the treatment of constipation. Common adverse reactions include abdominal colic, abdominal discomfort, diarrhea and proctitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Tablet Forms=

• For temporary relief of occasional constipation and irregularity
• This product generally produces a bowel movement in 6 to 12 hours

Dosing Information

• Take with a glass of water

This image is provided by the National Library of Medicine.

Suppository Form

• For the relief of occasional constipation.
• Bowel movement is generally produced in 15 minutes to 1 hour.

Dosing Information

• See chart below for dose
• Remove foil wrapper
• Insert suppository well up into the rectum as indicated, and retain it about 15 to 20 minutes

This image is provided by the National Library of Medicine.

• In the presence of anal fissures or hemorrhoids, suppositories should be coated at the tip with petroleum jelly.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Bisacodyl in adult patients.

Non–Guideline-Supported Use

• Bowel care - Spinal cord injury
• Neurogenic bowel

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Bisacodyl in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Bisacodyl in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Bisacodyl in pediatric patients.

Contraindications

There is limited information regarding Bisacodyl Contraindications in the drug label.

Warnings

Oral Form

Do not use

• If you cannot swallow without chewing.

Ask a doctor before use If you have

• Stomach pain, nausea, or vomiting
• A sudden change in bowel habits that lasts more than 2 weeks.

When using this product

• Do not chew or crush tablet(s)
• Do not use within 1 hour after taking an antacid or milk
• It may cause stomach discomfort, faintness and cramps

Stop use and ask a doctor if

• You have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
• You need to use a laxative for more than 1 week

If pregnant or breast-feeding

• Ask a health professional before use.

Keep out of reach of children

• In case of overdose, get medical help or contact a Poison Control Center right away.

Suppository Form

• For rectal use only

• Do not use laxative products for a period longer than one week unless directed by a doctor

• Ask a doctor before use if you have

• Abdominal pain, nausea or vomiting
• A sudden change in bowel habits that lasts longer than 2 weeks

• Stop use and ask a doctor if rectal bleeding occurs or you fail to have a bowel movement after using a laxative. These may be signs of a serious condition.

• Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

• Nausea, vomiting, abdominal pain
• It may cause stomach discomfort, faintness and cramps
• A sudden change in bowel habits that lasts more than 2 weeks

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Bisacodyl in the drug label.

Drug Interactions

There is limited information regarding Drug Interactions of Bisacodyl in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Ask a health professional before use.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bisacodyl in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Bisacodyl during labor and delivery.

Nursing Mothers

• Ask a health professional before use.

Pediatric Use

There is no FDA guidance on the use of Bisacodyl with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Bisacodyl with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Bisacodyl with respect to specific gender populations.

Race

There is no FDA guidance on the use of Bisacodyl with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Bisacodyl in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Bisacodyl in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Bisacodyl in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Bisacodyl in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Suppository

Monitoring

There is limited information regarding Monitoring of Bisacodyl in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Bisacodyl in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Bisacodyl in the drug label.

Pharmacology

Bisacodyl
Systematic (IUPAC) name
(pyridin-2-ylmethanediyl)dibenzene-4,1-diyl diacetate OR 4,4'-(pyridin-2-ylmethylene)bis(4,1-phenylene) diacetate
Identifiers
CAS number	603-50-9
ATC code	A06AB02 A06AG02 (WHO)
PubChem	2391
Chemical data
Formula	Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass	361.391 g/mol
SMILES	eMolecules & PubChem
Pharmacokinetic data
Bioavailability	15%
Metabolism	Hepatic (CYP450-mediated)
Half life	16 Hours
Excretion	primarily in the feces, systemically absorbed drug is excreted in the urine
Therapeutic considerations
Pregnancy cat.	C
Legal status	OTC
Routes	Oral, rectal

Mechanism of Action

• Bisacodyl works by stimulating enteric nerves to cause colonic mass movements (contractions). It is also a contact laxative; it increases fluid and NaCl secretion. Action of bisacodyl on small intestine is negligible; stimulant laxatives mainly promote evacuation of the colon

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Bisacodyl in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Bisacodyl in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Bisacodyl in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Bisacodyl in the drug label.

How Supplied

There is limited information regarding Bisacodyl How Supplied in the drug label.

Storage

• Store between 20º-25ºC (68º-77ºF)

Images

Drug Images

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Package and Label Display Panel

Oral Form=

Compare to the active ingredient in Dulcolax®*

Laxative

Bisacodyl

Stimulant laxative for gentle, dependable overnight relief Comfort Coated TABLETS 5 mg Each

• This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of Dulcolax® Laxative.

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO.

5000 KANSAS AVE

KANSAS CITY, KS 66106

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

This image is provided by the National Library of Medicine.

Suppository Form

NDC 0713-0109-08 G&W® BISAC-EVAC™ Bisacodyl USP LAXATIVE 8 SUPPOSITORIES 10 mg each

This image is provided by the National Library of Medicine.

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Bisacodyl in the drug label.

Precautions with Alcohol

• Alcohol-Bisacodyl interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Dulcolax Correctol Doxidan

• Biscolax®
• Bisac-Evac®
• Alophen®
• Fleet Bisacodyl®
• Feen-A-Mint®

Look-Alike Drug Names

• Dulcolax®(bisacodyl) - Dulcolax® (docusate sodium)

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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