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تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
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Bisacodyl: Drug information

Bisacodyl: Drug information
(For additional information see "Bisacodyl: Patient drug information" and see "Bisacodyl: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Bisacodyl EC [OTC];
  • Biscolax [OTC] [DSC];
  • Correct [OTC] [DSC];
  • Ducodyl [OTC];
  • Dulcolax [OTC];
  • Ex-Lax Ultra [OTC];
  • Fleet Bisacodyl [OTC];
  • Gentle Laxative [OTC];
  • GoodSense Bisacodyl EC [OTC];
  • GoodSense Bisacodyl Laxative [OTC];
  • GoodSense Womens Laxative [OTC];
  • OneLAX [OTC];
  • The Magic Bullet [OTC];
  • Womens Laxative [OTC]
Pharmacologic Category
  • Laxative, Stimulant
Dosing: Adult
Bowel cleansing

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

Constipation

Constipation:

Oral: 5 to 15 mg once daily

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

Dosing: Kidney 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

(For additional information see "Bisacodyl: Pediatric drug information")

Constipation

Constipation:

Note: Other agents (eg, polyethylene glycol 3350) are preferred for constipation maintenance therapy. Stimulant laxatives (eg, bisacodyl) may be used as additional or second-line therapy (NASPGHAN [Tabbers 2014]).

Oral (NASPGHAN [Tabbers 2014]; manufacturer’s labeling):

Note: Must be able to swallow tablet whole; tablet should not be crushed.

Children 3 to <10 years: Limited data available in ages <6 years: Oral: 5 mg once daily.

Children 10 to <12 years: Oral: 5 to 10 mg once daily.

Children ≥12 years and Adolescents: Oral: 5 to 15 mg once daily.

Rectal:

Suppository:

Children 2 to ≤10 years: Limited data available in ages <6 years: Rectal: 5 mg (1/2 suppository) once daily (NASPGHAN [Tabbers 2014]; manufacturer's labeling).

Children >10 years and Adolescents: Rectal: 5 to 10 mg (1/2 to 1 suppository) once daily (NASPGHAN [Tabbers 2014]; manufacturer's labeling).

Enema: Note: 30 mL bisacodyl is delivered per 37 mL bottle:

Children 2 to ≤10 years: Limited data available: Rectal: 5 mg (15 mL) once daily (NASPGHAN [Tabbers 2014]).

Children >10 years and Adolescents: Limited data available in children <12 years: Rectal: 5 to 10 mg (15 to 30 mL) once daily (NASPGHAN [Tabbers 2014]; manufacturer's labeling).

Dosing: Kidney 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.

Dosing: Older Adult

Refer to adult dosing.

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:

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

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

Gentle Laxative: 10 mg (50 ea)

OneLAX: 10 mg (12 ea, 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 #6(sunset yellow)alumin lake, methylparaben, propylparaben, quinoline (d&c yellow #10) aluminum lake, sodium benzoate]

Bisacodyl EC: 5 mg [contains corn starch, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake]

Bisacodyl EC: 5 mg [contains fd&c yellow #6(sunset yellow)alumin lake, methylparaben, propylparaben, quinoline (d&c yellow #10) aluminum lake, sodium benzoate]

Bisacodyl EC: 5 mg [contains fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake]

Correct: 5 mg [DSC]

Ducodyl: 5 mg

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

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

GoodSense Bisacodyl EC: 5 mg [contains corn starch, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake]

GoodSense Bisacodyl Laxative: 5 mg [contains fd&c yellow #6(sunset yellow)alumin lake, methylparaben, propylparaben, quinoline (d&c yellow #10) aluminum lake, sodium benzoate]

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

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

Generic Equivalent Available: US

May be product dependent

Administration: Adult

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.

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. Maintain position until urge to evacuate is strong (usually 5 to 20 minutes).

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

Administration: Pediatric

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

Rectal:

Suppository: Remove foil, insert into rectum with pointed end first. Retain in rectum for ~15 to 20 minutes. If suppository needs to be cut to obtain appropriate dose, cut suppository lengthwise with a sharp knife/blade prior to administration (Bowden 2010).

Enema: Administer with patient lying on left side and knees bent or with patient kneeling and head and chest leaning forward until left side of face is resting comfortably. Shake well; remove protective shield and gently insert enema tip into rectum with slight side to side movement with tip pointing toward navel; have patient bear down if possible. Do not force the enema tip into the rectum as this may cause injury. Squeeze the bottle until nearly all liquid is expelled; some liquid will remain in unit after use. Gently remove enema tip from rectum; patient should maintain position until urge to evacuate is strong (usually 5 to 20 minutes).

Use: Labeled Indications

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

Constipation: Temporary relief of occasional constipation and irregularity.

Medication Safety Issues
Sound-alike/look-alike issues:

Doxidan may be confused with doxepin

Dulcolax (bisacodyl) may be confused with Dulcolax (docusate)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

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

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.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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

Sodium Sulfate: Laxatives (Stimulant) may enhance the adverse/toxic effect of Sodium Sulfate. Specifically, the risk of mucosal ulceration or ischemic colitis may be increased. Risk X: Avoid combination

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).

Breastfeeding 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).

Dietary Considerations

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

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

Pharmacokinetics

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)

Pricing: US

Enema (Fleet Bisacodyl Rectal)

10 mg/30 mL (per mL): $0.11

Suppository (Bisacodyl Rectal)

10 mg (per each): $0.22 - $0.42

Suppository (OneLAX Rectal)

10 mg (per each): $0.18

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.

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 (AU, 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);
  • Ducodil (BR);
  • Dulco Laxo (ES);
  • Dulco-lax perles (GB);
  • Dulcobis (PL);
  • 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, 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);
  • Isilax (BR);
  • 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);
  • Laxamag (RO);
  • Laxamin (AR);
  • Laxana (ID);
  • Laxans-ratiopharm (LU);
  • Laxbene (AT);
  • Laxcodyl (TH);
  • Laxet (BD);
  • Laxin (EG);
  • Laxocodyl (AE, BH, JO, KW, SA);
  • Longshutong (CN);
  • Megalax (ZA);
  • Metalax (FI);
  • Moderlax (PT);
  • Mucinum (BE);
  • Oralax (ZW);
  • Perilax (DK, ZA);
  • Prolaxan (ID);
  • Purgo-Pil (BE, LU);
  • Pyrilax (PL);
  • Relaxium (BD);
  • Satolax-10 (JP);
  • Stadalax (CZ, RO);
  • Stolax (ID);
  • Tirgon N (LU);
  • Toilax (DK, FI, IE, NO, SE);
  • Ultralax (AR);
  • Vesilac (PH);
  • Zycolax (LK)


For country code abbreviations (show table)
  1. Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319. [PubMed 11487763]
  2. 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]
  3. Bowden VR, Greenberg CS. Pharmacologic management chap 9. Children and Their Families: The Continuum of Care. 2010;11:303-323.
  4. 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]
  5. Cullen G and O'Donoghue D, "Constipation and Pregnancy," Best Pract Res Clin Gastroenterol, 2007, 21(5):807-18. [PubMed 17889809]
  6. Dulcolax suppository (bisacodyl) [prescribing information]. Chattanooga, TN: Chattem Inc; November 2018.
  7. Dulcolax tablets (bisacodyl) [prescribing information]. Chattanooga, TN: Chattem Inc; December 2018.
  8. Fleet enema (bisacodyl) (prescribing information). Lynchburg, VA: C.B. Fleet Company Inc; received February 2021.
  9. 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]
  10. 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]
  11. Prather CM, "Pregnancy-Related Constipation," Curr Gastroenterol Rep, 2004, 6(5):402-4. [PubMed 15341717]
  12. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics.1997;99(2):268-278. [PubMed 9024461]
  13. 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]
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