Bisacodyl
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]
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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
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
- 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
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
- Ask a health professional before use.
- 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 | |
| ATC code | A06 A06AG02 (WHO) |
| PubChem | |
| 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 | & |
| 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
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.
Suppository Form
NDC 0713-0109-08 G&W® BISAC-EVAC™ Bisacodyl USP LAXATIVE 8 SUPPOSITORIES 10 mg each
{{#ask: Label Page::Bisacodyl |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
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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