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Docusate: Drug information

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

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Colace [OTC];
  • Diocto [OTC] [DSC];
  • Docu Liquid [OTC];
  • Docu Soft [OTC] [DSC];
  • Docu [OTC];
  • Docuprene [OTC] [DSC];
  • Docusate Mini [OTC];
  • Docusil [OTC] [DSC];
  • DocuSol Kids [OTC];
  • DocuSol Mini [OTC];
  • DOK [OTC];
  • Dulcolax Stool Softener [OTC];
  • Enemeez Mini [OTC];
  • GoodSense Stool Softener [OTC] [DSC];
  • Healthy Mama Move It Along [OTC];
  • Kao-Tin [OTC] [DSC];
  • KS Stool Softener [OTC] [DSC];
  • Laxa Basic [OTC] [DSC];
  • Pedia-Lax [OTC];
  • Promolaxin [OTC] [DSC];
  • Silace [OTC] [DSC];
  • Stool Softener [OTC]
Pharmacologic Category
  • Stool Softener
Dosing: Adult

Note: The following are general dosing guidelines; refer to specific product labeling for dosing instructions.

Stool softener

Stool softener:

Oral:

Docusate calcium: 240 mg once daily.

Docusate sodium: 50 to 360 mg once daily or in divided doses.

Rectal: 283 mg per 5 mL: 283 mg (1 enema) 1 to 3 times daily.

Ceruminolytic

Ceruminolytic (off-label use): Intra-aural: Administer 1 mL of docusate sodium in 2 mL syringes; if no clearance in 15 minutes, irrigate with 50 or 100 mL lukewarm normal saline (Singer 2000).

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 "Docusate: Pediatric drug information")

Constipation, treatment; stool softener

Constipation (occasional), treatment; stool softener:

Docusate sodium:

Oral:

Manufacturer's labeling:

Children 2 years to <12 years: 50 to 150 mg/day in single or divided doses.

Children ≥12 years and Adolescents: 50 to 360 mg/day in single or divided doses.

Alternate dosing:

Weight-directed dosing: Infants and Children: 5 mg/kg/day in 1 to 4 divided doses (Nelson 1996).

Age-directed (fixed) dosing:

Infants ≥6 months and Children <2 years: 12.5 mg 3 times daily (NICE 2010).

Children ≥2 and Adolescents: 40 to 150 mg/day in 1 to 4 divided doses (Kliegman 2011); in children ≥12 years and adolescents, doses up to 500 mg/day divided may be used (NICE 2010).

Rectal:

Children 2 to <12 years:

100 mg/5 mL: 100 mg (1 unit) once daily.

283 mg/5 mL: 283 mg (1 unit) once daily.

Children ≥12 years and Adolescents: 283 mg/5mL: 283 mg (1 unit) 1 to 3 times daily.

Docusate calcium: Children ≥12 years and Adolescents: 240 mg once daily.

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the 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

Capsule, Oral, as calcium:

Kao-Tin: 240 mg [DSC] [sodium free; contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), fd&c yellow #6 (sunset yellow)]

Stool Softener: 240 mg [DSC] [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), fd&c yellow #6 (sunset yellow)]

Generic: 240 mg

Capsule, Oral, as sodium:

Colace: 100 mg [stimulant free; contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), fd&c yellow #6 (sunset yellow)]

Docu Soft: 100 mg [DSC]

Docusil: 100 mg [DSC]

DOK: 100 mg [DSC], 250 mg [DSC] [contains fd&c red #40 (allura red ac dye), fd&c yellow #6 (sunset yellow)]

Dulcolax Stool Softener: 100 mg [contains fd&c red #40 (allura red ac dye), fd&c yellow #6 (sunset yellow)]

GoodSense Stool Softener: 100 mg [DSC] [gluten free; contains fd&c red #40 (allura red ac dye), fd&c yellow #6 (sunset yellow)]

KS Stool Softener: 100 mg [DSC] [stimulant free; contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), fd&c yellow #5 (tartrazine), methylparaben, propylparaben]

Laxa Basic: 100 mg [DSC]

Stool Softener: 100 mg

Stool Softener: 100 mg [contains fd&c red #40 (allura red ac dye), fd&c yellow #6 (sunset yellow)]

Stool Softener: 100 mg [contains fd&c red #40 (allura red ac dye), fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]

Stool Softener: 250 mg [contains fd&c red #40 (allura red ac dye), fd&c yellow #6 (sunset yellow)]

Stool Softener: 100 mg, 250 mg [DSC] [stimulant free; contains fd&c red #40 (allura red ac dye), fd&c yellow #6 (sunset yellow)]

Generic: 100 mg, 250 mg

Enema, Rectal, as sodium:

Docusate Mini: 283 mg/5 mL (5 mL)

DocuSol Kids: 100 mg/5 mL (5 ea) [contains polyethylene glycol (macrogol)]

DocuSol Mini: 283 mg/5 mL (5 ea)

Enemeez Mini: 283 mg/5 mL (5 mL)

Liquid, Oral, as sodium:

Diocto: 50 mg/5 mL (473 mL [DSC]) [contains parabens, polyethylene glycol (macrogol)]

Docu: 50 mg/5 mL (10 mL [DSC], 473 mL) [contains methylparaben, polyethylene glycol (macrogol), propylene glycol, propylparaben, sodium benzoate; vanilla flavor]

Docu Liquid: 100 mg/10 mL (10 mL) [contains methylparaben, polyethylene glycol (macrogol), propylene glycol, propylparaben, sodium benzoate; vanilla flavor]

Pedia-Lax: 50 mg/15 mL (118 mL) [alcohol free, dye free; contains edetate (edta) disodium, methylparaben, polyethylene glycol (macrogol), propylene glycol, propylparaben; fruit punch flavor]

Silace: 150 mg/15 mL (473 mL [DSC]) [lemon-vanilla flavor]

Generic: 50 mg/5 mL (5 mL, 10 mL, 473 mL); 100 mg/10 mL (10 mL); 150 mg/15 mL (473 mL [DSC])

Syrup, Oral, as sodium:

Diocto: 60 mg/15 mL (473 mL [DSC]) [contains fd&c red #40 (allura red ac dye), propylene glycol, saccharin sodium, sodium benzoate]

Silace: 60 mg/15 mL (473 mL [DSC]) [contains alcohol, usp; peppermint flavor]

Generic: 60 mg/15 mL (25 mL)

Tablet, Oral, as sodium:

Docuprene: 100 mg [DSC] [contains sodium benzoate]

DOK: 100 mg

DOK: 100 mg [DSC] [scored]

Healthy Mama Move It Along: 100 mg [scored; stimulant free; contains sodium benzoate]

Promolaxin: 100 mg [DSC] [scored; contains sodium benzoate]

Stool Softener: 100 mg

Generic: 100 mg

Generic Equivalent Available: US

Yes

Administration: Adult

Also refer to specific product labeling for administration instructions.

Oral: Administer as a single daily dose or in divided doses; ensure adequate fluid intake. Mix docusate liquid (50 mg per 5 mL) with milk or fruit juice to prevent throat irritation.

Rectal: For rectal use only. Lubricate tip prior to insertion by placing a few drops of the liquid from the enema on the shaft prior to insertion; may also apply a few drops of enema contents or lubricant to the anus prior to insertion. Gently insert lubricated applicator tip into rectum. Grasp bottle firmly and squeeze slowly to empty the contents. Discard after administration.

Administration: Pediatric

Oral: Docusate liquid products may have bitter taste due to active ingredient, consider mixing with milk, fruit juice, or infant formula to mask taste; ensure adequate fluid intake

Rectal: Empty contents of enema into rectum, discard disposable administration device

Use: Labeled Indications

Stool softener: Prevention of straining during defecation and constipation associated with hard, dry stools; relief of occasional constipation

Use: Off-Label: Adult

Ceruminolytic

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

Colace may be confused with Calan, Cozaar

International issues:

Docusate may be confused with Doxinate brand name for doxylamine and pyridoxine [India]

Adverse Reactions

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

1% to 10%: Respiratory: Throat irritation (liquid)

Warnings/Precautions

Dosage forms 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 1997; CDC 1982); some data suggests that benzoate displaces bilirubin.

• Enema: For rectal use only; lubricate tip prior to insertion. Discontinue use and notify health care provider if rash around the anus/rectal irritation occurs or if resistance is encountered with insertion; forcing the tube may result in injury or damage to the rectum.

Other warnings/precautions:

• Self-medication (OTC use): When used for self-medication (OTC), patients should be instructed to contact health care provider prior to use if nausea, stomach pain, or vomiting are present, or if a sudden change in bowel habits occurs and persists over 14 days. Concomitant use with mineral oil is not recommended. Patients should discontinue use and notify health care provider if rectal bleeding occurs, if a bowel movement fails to occur after use, or if use is needed >7 days.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Shehab 2009).

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Hypomagnesemia was reported in a newborn following chronic maternal overuse of docusate sodium throughout pregnancy (Schindler 1984).

Treatment of constipation in pregnant women is similar to that of nonpregnant patients and medications may be used when diet and lifestyle modifications are not effective. Agents other than docusate are recommended in pregnancy (Body 2016). Stool softeners may be used for the treatment of hemorrhoids (Shin 2015).

Breastfeeding Considerations

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

Because there is some systemic absorption, use of other agents may be preferred in breastfeeding women (Lewis 1985). Diarrhea was noted in a breastfeeding infant following maternal use of danthron and docusate sodium (Greenhalf 1973).

Dietary Considerations

Some products may contain sodium.

Monitoring Parameters

Rectal: Periodic rectal exams are recommended in patients with impaired rectal function, especially loss of sensation.

Mechanism of Action

Reduces surface tension of the oil-water interface of the stool resulting in enhanced incorporation of water and fat allowing for stool softening (Roerig 2010).

Pharmacokinetics

Onset of action: Oral: 12 to 72 hours; Rectal: 2 to 15 minutes

Excretion: Feces (Gattuso 1994)

Pricing: US

Capsules (Colace Oral)

100 mg (per each): $0.32

Capsules (Docusate Calcium Oral)

240 mg (per each): $0.06 - $0.12

Capsules (Docusate Sodium Oral)

100 mg (per each): $0.02 - $0.08

250 mg (per each): $0.05 - $0.26

Capsules (DSS Oral)

250 mg (per each): $0.08

Enema (DocuSol Kids Rectal)

100 mg/5 mL (per each): $4.30

Enema (DocuSol Mini Rectal)

283 mg/5 mL (per mL): $0.86

Enema (Enemeez Mini Rectal)

283 mg/5 mL (per mL): $0.78

283 mg/5 mL (per each): $0.86

Liquid (Docu Liquid Oral)

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

Liquid (Pedia-Lax Oral)

50 mg/15 mL (per mL): $0.07

Syrup (Docusate Sodium Oral)

60 mg/15 mL (per mL): $0.10

Tablets (DOK Oral)

100 mg (per each): $0.03

Tablets (Healthy Mama Move It Along Oral)

100 mg (per each): $0.15

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
  • Audilyse (DE);
  • Cerumex (AR);
  • Coloxyl (AU, NZ);
  • Cusate (TH);
  • Dewax (BH, JO, SA, TH);
  • Diocaps (CR, DO, GT, HN, MX, NI, PA, SV);
  • Dioctyl (GB);
  • Doculyse (FR);
  • Docusaat FNA (NL);
  • Docuset (BD);
  • Docusoft (IL);
  • Docusol (GB);
  • Doslax (IN);
  • Dulcocomfort (EC);
  • Egycusate (EG);
  • Emtix (FI);
  • Forumen (ID);
  • Green Morning (KR);
  • Irwax (PH);
  • Jamylene (FR);
  • Klyx (FI, NL, NO, SE);
  • Lambanol (IT);
  • Lassativo (EG);
  • Laxol (PL);
  • Molcer (GB);
  • Molcer Ear Drops (LK);
  • Mulin (JO);
  • Norgalax (AE, BE, CH, CY, DE, FR, GB, IQ, IR, KW, LB, LU, LY, NL, OM, QA, RU, SA, SY, UA, VN, YE);
  • Norgalax Micro-enema (GB);
  • Otitex (DE);
  • Otoclear (PH);
  • Otosol (PH);
  • Otowax (PH);
  • Phillips (AR);
  • Purgeron (JP);
  • Regutol (AE, CY, IQ, IR, KW, LB, LY, OM, SA, SY, YE);
  • Soliwax (GB);
  • Soluwax Ear Drops (MY, SG);
  • Wax-Eze (HK);
  • Waxsol (AU, BH, GB, IE, JO, LB, LK, NZ, QA, SA, TH);
  • Wondril (EG);
  • Yal (CZ);
  • Yi Ke Long (CN)


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. 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]
  4. Colace (docusate sodium) [prescribing information]. Stamford, CT: Purdue Products LP; November 2012.
  5. Colace Clear (docusate sodium) [prescribing information]. Stamford, CT: Purdue Products LP; February 2017.
  6. Docusate Sodium Extra Strength [prescribing information]. Livonia, MI: Major Pharmaceuticals; October 2019.
  7. DocuSol Kids (docusate sodium) [prescribing information]. Phoenix, AZ: Summit Pharmaceuticals.
  8. DocuSol Mini-Enema (docusate sodium) [prescribing information]. Phoenix, AZ: Alliance Labs.
  9. DOK (docusate sodium) [prescribing information]. Livonia, MI: Major Pharmaceuticals; June 2018.
  10. Dulcolax Stool Softener (docusate sodium) [prescribing information]. Chattanooga, TN: Chattem, Inc; received February 2020.
  11. Enemeez (docusate sodium) [prescribing information]. Phoenix, AZ: Alliance Labs.
  12. Gattuso JM, Kamm MA. Adverse effects of drugs used in the management of constipation and diarrhoea. Drug Saf. 1994;10(1):47-65. [PubMed 8136086]
  13. Greenhalf JO, Leonard HS. Laxatives in the treatment of constipation in pregnant and breast-feeding mothers. Practitioner. 1973;210(256):259-263. [PubMed 4570522]
  14. "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics Committee on Drugs. Pediatrics. 1997;99 (2):268-278. [PubMed 9024461]
  15. Lewis JH, Weingold AB. The use of gastrointestinal drugs during pregnancy and lactation. Am J Gastroenterol. 1985;80(11):912-923. [PubMed 2864852]
  16. McCarter DF, Courtney AU, Pollart SM. Cerumen impaction. Am Fam Physician. 2007;75(10):1523-1528. [PubMed 17555144]
  17. National Collaborating Centre for Women's and Children's Health (UK). Constipation in children and young people: diagnosis and management of idiopathic childhood constipation in primary and secondary care. London, UK: RCOG Press; 2010. [PubMed 22220325]
  18. Nelson WE, Behrman RE, Arvin AM, Kliegman RM, eds. Nelson Textbook of Pediatrics. 15th ed. Philadelphia, PA: WB Saunders Company; 1996: 2058-2078.
  19. Roerig JL, Steffen KJ, Mitchell JE, Zunker C. Laxative abuse: epidemiology, diagnosis and management. Drugs. 2010;70(12):1487-1503. doi:10.2165/11898640-000000000-00000 [PubMed 20687617]
  20. Schindler AM, “Isolated Neonatal Hypomagnesaemia Associated With Maternal Overuse of Stool Softener,” Lancet, 1984, 2(8406):822. [PubMed 6207396]
  21. Shin GH, Toto EL, Schey R. Pregnancy and postpartum bowel changes: constipation and fecal incontinence. Am J Gastroenterol. 2015;110(4):521‐530. doi:10.1038/ajg.2015.76 [PubMed 25803402]
  22. Singer AJ, Sauris E, and Viccellio AS, “Ceruminolytic Effects of Docusate Sodium: A Randomized, Controlled Trial,” Ann Emerg Med, 2000, 36(3):228-32. [PubMed 10969225]
  23. Stool Softener DC Laxative (docusate calcium) [prescribing information]. Livonia, MI: Rugby Laboratories; April 2013.
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