Bisacodyl

Pharmacologic Category

Laxative, Stimulant

Dosing: Adult

Bowel cleansing (enema only): Rectal: 10 mg (1 enema) as single dose

Constipation:

Oral: 5 to 15 mg once daily

Rectal: Enema, suppository: 10 mg (1 enema or suppository) once daily

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

Constipation:

Oral: Limited data available in patients <6 years:

Children ≥3 years to <10 years: 5 mg once daily (NASPGHAN/ESPGHAN [Tabbers 2014]).

Children 10 to <12 years: 5 to 10 mg once daily (NASPGHAN/ESPGHAN [Tabbers 2014]).

Children ≥12 years and Adolescents: 5 to 15 mg once daily (NASPGHAN/ESPGHAN [Tabbers 2014]; manufacturer's labeling).

Rectal:

Suppository: Limited data available in children <6 years:

Children 2 to ≤10 years: 5 mg (1/2 suppository) once daily (NASPGHAN/ESPGHAN [Tabbers 2014]).

Children >10 years and Adolescents: 5 to 10 mg once daily (NASPGHAN/ESPGHAN [Tabbers 2014]).

Enema: Limited data available in children <12 years:

Children ≥2 to 10 years: 5 mg once daily (NASPGHAN/ESPGHAN [Tabbers 2014]).

Children >10 years and Adolescents: 5 to 10 mg once daily (NASPGHAN/ESPGHAN [Tabbers 2014]).

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Use: Labeled Indications

Bowel cleansing (enema only): Bowel cleansing prior to rectal examination.

Constipation: Temporary relief of occasional constipation and irregularity.

* See Uses in AHFS Essentials for additional information.

Clinical Practice Guidelines

Constipation:

AGA, “Guideline on the Medical Management of Opioid-Induced Constipation,” October 2018

The American Society of Colon and Rectal Surgeons, “Clinical Practice Guideline for the Evaluation and Management of Constipation,” 2017

Administration: Oral

Administer with water. Swallow tablet whole; do not break, chew, or crush; do not administer within 1 hour of antacids, milk, or dairy products.

Bariatric surgery: Tablet, delayed release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. Do not cut or crush in order to avoid gastric irritation.

Administration: Rectal

Enema: Shake well; remove protective shield, insert tip into rectum with slight side to side movement; squeeze the bottle until nearly all liquid expelled (some liquid will remain in unit after use). Gently remove the unit, a small amount of liquid will remain in unit after use.

Suppository: Remove foil, insert into rectum with pointed end first. Retain in rectum for 15 to 20 minutes.

Administration: Pediatric

Oral: Administer on an empty stomach with water; patient should swallow tablet whole; do not break or chew enteric-coated tablet; do not administer within 1 hour of ingesting antacids, alkaline material, milk, or dairy products

Rectal:

Suppository: Remove foil, insert into rectum with pointed end first. Retain in rectum for 15 to 20 minutes.

Enema: Shake well; remove protective shield, insert tip into rectum with slight side to side movement; squeeze the bottle until nearly all liquid expelled (some liquid will remain in unit after use). Gently remove the unit, a small amount of liquid will remain in unit after use.

Dietary Considerations

Tablet: Do not administer within 1 hour of milk, dairy products, or an antacid.

Storage/Stability

Oral: Store at 20°C to 25°C (68°F to 77°F); protect from humidity.

Rectal: Store at <30°C (86°F).

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat constipation.

• It is used as a laxative to clean out the colon before an exam.

Frequently reported side effects of this drug

• Abdominal pain

• Abdominal cramps

• Rectal burning

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• A significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Safety Issues

Sound-alike/look-alike issues:

Warnings/Precautions

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

Other warnings/precautions:

• Appropriate use: Tablets: Do not chew or crush; do not use if you cannot swallow without chewing. Do not administer within 1 hour after taking an antacid, milk, or any dairy products.

• Appropriate use: Enema/Suppositories: For rectal use only, discontinue use and consult a health care provider if rectal bleeding occurs or if no bowel movement is produced after use.

• Self-medication (OTC use): Consult a health care provider prior to use if stomach pain, nausea, vomiting, or a sudden change in bowel movements lasting >2 weeks occurs, or if you have already used a laxative, including bisacodyl, for >1 week. Use may cause stomach discomfort, faintness, rectal burning, and mild cramps. Discontinue use and consult a health care provider if use >1 week is needed.

* See Cautions in AHFS Essentials for additional information.

Geriatric Considerations

The chronic use of stimulant cathartics is inappropriate and should be avoided; although constipation is a common complaint from elderly, such complaints require evaluation; elderly are often predisposed to constipation due to disease, drugs, immobility, and a decreased fluid intake, partially because they have a blunted “thirst reflex” with aging; short-term use of stimulants is best; if prophylaxis is desired, this can be accomplished with bulk agents (psyllium), stool softeners, and hyperosmotic agents (sorbitol 70%); stool softeners are unnecessary if stools are well hydrated, soft, or “mushy”.

Pregnancy Considerations

Systemic exposure following maternal use of bisacodyl is limited. Plasma concentrations of BHPM (the active metabolite of bisacodyl) are low (median: 61 ng/mL; range: 20 to 118 ng/mL) and the pharmacokinetics are highly variable following oral doses of 10 mg/day for 7 days to women immediately postpartum (Friedrich 2011).

Use of bisacodyl should be limited during pregnancy due to an increased risk of adverse events, such as electrolyte abnormalities. When dietary changes and lifestyle modifications are insufficient, agents other than bisacodyl are recommended for the treatment of constipation in pregnant women (Body 2016; Gomes 2018).

Breast-Feeding Considerations

It is not known if bisacodyl is present in breast milk.

Systemic exposure following maternal use is limited. Neither bisacodyl nor its active metabolite (BHPM) were detectable in breast milk following administration of bisacodyl 10 mg once daily for 7 days to eight breastfeeding women (lower limit of detection: 1 ng/mL) (Friedrich 2011).

Briggs' Drugs in Pregnancy & Lactation

• Bisacodyl

Adverse Reactions

<1%: Abdominal cramps (mild), electrolyte disturbance (metabolic acidosis or alkalosis, hypocalcemia), nausea, rectal irritation (burning), vertigo, vomiting

* See Cautions in AHFS Essentials for additional information.

Allergy and Idiosyncratic Reactions

• Aniline Dye Allergy
• Diphenylmethane Laxative Allergy

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

Antacids: May diminish the therapeutic effect of Bisacodyl. Antacids may cause the delayed-release bisacodyl tablets to release drug prior to reaching the large intestine. Gastric irritation and/or cramps may occur. Management: Antacids should not be used within 1 hour before bisacodyl administration. Risk D: Consider therapy modification

Dichlorphenamide: Laxatives may enhance the hypokalemic effect of Dichlorphenamide. Risk C: Monitor therapy

Polyethylene Glycol-Electrolyte Solution: Bisacodyl may enhance the adverse/toxic effect of Polyethylene Glycol-Electrolyte Solution. Risk C: Monitor therapy

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Enema, Rectal:

Fleet Bisacodyl: 10 mg/30 mL (37 mL)

Suppository, Rectal:

Bisac-Evac: 10 mg (1 ea [DSC], 8 ea [DSC], 12 ea [DSC], 50 ea [DSC], 100 ea [DSC], 500 ea [DSC], 1000 ea [DSC])

Biscolax: 10 mg (12 ea [DSC], 100 ea)

Dulcolax: 10 mg (4 ea, 8 ea, 16 ea, 28 ea, 50 ea)

Gentle Laxative: 10 mg (50 ea)

The Magic Bullet: 10 mg (10 ea, 100 ea)

Generic: 10 mg (12 ea, 50 ea, 100 ea)

Tablet Delayed Release, Oral:

Bisacodyl EC: 5 mg

Bisacodyl EC: 5 mg [contains corn starch, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake]

Bisacodyl EC: 5 mg [contains corn starch, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake, methylparaben, propylparaben]

Bisacodyl EC: 5 mg [contains corn starch, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake, methylparaben, propylparaben, sodium benzoate]

Bisacodyl EC: 5 mg [contains fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake]

Bisacodyl EC: 5 mg [contains fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake, methylparaben, propylparaben, sodium benzoate]

Correct: 5 mg

Ducodyl: 5 mg

Dulcolax: 5 mg [contains fd&c yellow #10 (quinoline yellow), methylparaben, propylparaben, sodium benzoate]

Ex-Lax Ultra: 5 mg [contains fd&c yellow #6 (sunset yellow), methylparaben]

Fleet Laxative: 5 mg [DSC]

GoodSense Bisacodyl EC: 5 mg [contains corn starch, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake]

GoodSense Womens Laxative: 5 mg [gluten free; contains corn starch]

Womens Laxative: 5 mg [contains fd&c blue #1 aluminum lake, sodium benzoate, tartrazine (fd&c yellow #5)]

Anatomic Therapeutic Chemical (ATC) Classification

• A06AB02

Generic Available (US)

May be product dependent

Pricing: US

Enema (Fleet Bisacodyl Rectal)

10 mg/30 mL (per mL): $0.07

Suppository (Bisacodyl Rectal)

10 mg (per each): $0.14 - $0.42

Suppository (The Magic Bullet Rectal)

10 mg (per each): $1.19

Tablet, EC (Ex-Lax Ultra Oral)

5 mg (per each): $0.22

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Stimulates peristalsis by directly irritating the smooth muscle of the intestine, possibly the colonic intramural plexus; alters water and electrolyte secretion producing net intestinal fluid accumulation and laxation

Pharmacodynamics/Kinetics

Onset of action: Oral: 6 to 12 hours; Rectal: 0.25 to 1 hour (suppository), 5 to 20 minutes (enema)

Half-life: BHPM: ~8 hours (Friedrich 2011)

Distribution: Vd: BHPM: 289 L (after multiple doses) (Friedrich 2011)

Metabolism: Bisacodyl is metabolized to an active metabolite (BHPM) in the colon; BHPM is then converted in the liver to a glucuronide salt (Friedrich 2011)

Absorption: Oral, rectal: Systemic, <5% (Wald 2003)

Excretion: BHPM: Urine, bile (Friedrich 2011)

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Related Information

• Laxatives, Classification and Properties
• Oral Medications That Should Not Be Crushed or Altered

Index Terms

Doxidan

References

Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319.[PubMed 11487763]

Bisacodyl suppository [prescribing information]. Allegan, MI: Perrigo; November 2011.

Body C, Christie JA. Gastrointestinal diseases in pregnancy: nausea, vomiting, hyperemesis gravidarum, gastroesophageal reflux disease, constipation, and diarrhea. Gastroenterol Clin North Am. 2016;45(2):267‐283. doi:10.1016/j.gtc.2016.02.005[PubMed 27261898]

Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm[PubMed 6810084]

Correctol tablet (bisacodyl) [prescribing information]. Memphis: TN: MSD Consumer Care, Inc; June 2014.

Cullen G and O'Donoghue D, "Constipation and Pregnancy," Best Pract Res Clin Gastroenterol, 2007, 21(5):807-18.[PubMed 17889809]

Dahshan A, Lin CH, Peters J, et al, “A Randomized, Prospective Study to Evaluate the Efficacy and Acceptance of Three Bowel Preparations for Colonoscopy in Children,” Am J Gastroenterol, 1999, 94(12):3497-501.[PubMed 10606310]

Ducodyl (bisacodyl) [prescribing information]. Troy, MI: Prime Marketing; received January 2019.

Dulcolax tablets (bisacodyl) [prescribing information]. Chattanooga, TN: Chattem, Inc; received February 2020.

Fleet enema (bisacodyl) (prescribing information). Lynchburg, VA: C.B.Fleet Company, Inc.

Friedrich C, Richter E, Trommeshauser D, et al, "Absence of Excretion of the Active Moiety of Bisacodyl and Sodium Picosulfate Into Human Breast Milk: An Open-Label, Parallel-Group, Multiple-Dose Study in Healthy Lactating Women," Drug Metab Pharmacokinet, 2011, 26(5):458-64.[PubMed 21697613]

Gomes CF, Sousa M, Lourenço I, Martins D, Torres J. Gastrointestinal diseases during pregnancy: what does the gastroenterologist need to know? Ann Gastroenterol. 2018;31(4):385‐394. doi:10.20524/aog.2018.0264[PubMed 29991883]

Lo So Prep (bisacodyl) [prescribing information]. Lake Success, NY: Tower Laboratories Ltd, October 2010.

Prather CM, "Pregnancy-Related Constipation," Curr Gastroenterol Rep, 2004, 6(5):402-4.[PubMed 15341717]

"Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics.1997;99(2):268-278.[PubMed 9024461]

Tabbers MM, DiLorenzo C, Berger MY, et al. Evaluation and treatment of functional constipation in infants and children: evidence-based recommendations from ESPGHAN and NASPGHAN. J Pediatr Gastroenterol Nutr. 2014;58(2):258-274.[PubMed 24345831]

Brand Names: International

Abilaxine (EG); Alaxa (IT); Alsylax (CL); Anan (JP); Anulax (EC); Atzirut X (IL); Bekunis B (LU); Bilaxine (SY); Bioyl (TW); Bisacod (TH); Bisadyl (BH, EG); Bisakodils (EE); Bisalax (BG); Bisco (HK, PH); Bislax (LK); Bolax (ET); Buscolax (PH); Camvolax (LK); Conlax-10 (HK); Contalax (FR, IL); Corlex-5 (LK); Cosadin (PH); Custodiol (ID); Danalax (VN); Dissilax (AE, CY, IQ, IR, JO, KW, LY, OM, SA, SY, YE); Dulco Laxo (ES); Dulco-lax perles (GB); Dulcolan (VE); Dulcolax (AE, AR, AT, BB, BE, BF, BG, BH, BJ, BM, BR, BS, BZ, CH, CI, CN, CO, CR, CU, CY, CZ, DE, DK, DO, EG, ET, FR, GB, GH, GM, GN, GR, GT, GY, HK, HN, HR, HU, IE, IN, IQ, IR, IS, IT, JM, JO, KE, KR, KW, LB, LR, LU, LY, MA, ML, MR, MT, MU, MW, MX, MY, NE, NG, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PT, QA, RO, RU, SA, SC, SD, SE, SI, SK, SL, SN, SR, SV, SY, TH, TN, TR, TT, TW, TZ, UG, UY, VN, YE, ZM, ZW); Dulcorax (KR); Dulxative (PH); Duralax (BD); Entrolax (MT); Fenolax (CZ); Gencolax (TH); Johnlax (TW); Lax-Tab (AU, NZ); Laxabixal (ES); Laxacod (ID); Laxadin (IL); Laxadyl (AE, BF, BJ, CI, CY, ET, GH, GM, GN, IQ, IR, JO, KE, KW, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, QA, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZM, ZW); Laxana (ID); Laxans-ratiopharm (LU); Laxatin (TW); Laxbene (AT); Laxcodyl (TH); Laxet (BD); Laxin (EG); Laxocodyl (AE, BH, JO, KW, SA); Longshutong (CN); Megalax (ZA); Moderlax (PT); Mucinum (BE); Oralax (ZW); Perilax (DK, ZA); Prolaxan (ID); Purgo-Pil (BE, LU); Pyrilax (PL); Relaxium (BD); Satolax-10 (JP); Stadalax (CZ); Stolax (ID); Suben (TW); Tirgon N (LU); Toilax (DK, FI, IE, NO, SE); Vesilac (PH); Zu Zu Ton (TW); Zycolax (LK)

Last Updated 6/13/20