Docusate Sodium

Pharmacologic Category

Stool Softener

Dosing: Adult

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

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 (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)

* 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 (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: Renal 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.

Use: Labeled Indications

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

* See Uses in AHFS Essentials for additional information.

Use: Off-Label: Adult

​CeruminolyticLevel of Evidence [B]

Data from a small, prospective, randomized, double-blind controlled study comparing the intra-aural use of docusate to triethanolamine polypeptide (not available in the US) and subsequent irrigation with lukewarm normal saline as needed supports the use of docusate intra-aurally as a ceruminolytic Ref. Despite these data, the use of saline is still considered to be first-line Ref. Additional trials may be necessary to further define the role of intra-aural docusate in the treatment of this condition.

Level of Evidence Definitions

​Level of Evidence Scale

Clinical Practice Guidelines

Constipation:

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

Administration: 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.

Administration: 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

Dietary Considerations

Some products may contain sodium.

Storage/Stability

Store at room temperature. Protect from freezing, heat humidity, and light.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat constipation.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Abdominal cramps

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Rectal irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, 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 limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Medication Safety Issues

​Sound-alike/look-alike issues:

​International issues:

Contraindications

OTC labeling: When used for self-medication, do not use for longer than 7 days; when abdominal pain, nausea, or vomiting is present; or concomitantly with mineral oil (oral products only)

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 healthcare 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. Patients should discontinue use and notify healthcare provider if rectal bleeding occurs, if a bowel movement fails to occur after use, or if use is needed >7 days.

* See Cautions in AHFS Essentials for additional information.

Geriatric Considerations

A safe agent to be used in the elderly. Some evidence that doses <200 mg are ineffective. Stool softeners are unnecessary if stool is well hydrated or “mushy” and soft; shown to be ineffective used long-term.

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).

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).

Breast-Feeding 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).

Briggs' Drugs in Pregnancy & Lactation

• Docusate Sodium

Adverse Reactions

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

* See Cautions in AHFS Essentials for additional information.

Allergy and Idiosyncratic Reactions

• Aniline Dye Allergy

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

There are no known significant interactions.

Monitoring Parameters

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

Advanced Practitioners Physical Assessment/Monitoring

Instruct patient in proper use (avoid excessive or prolonged use).

Nursing Physical Assessment/Monitoring

Instruct patient in proper use (avoid excessive or prolonged use).

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 [sodium free; contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #6 (sunset yellow)]

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

Generic: 240 mg

Capsule, Oral, as sodium:

Colace: 100 mg [contains fd&c red #40, fd&c yellow #6 (sunset yellow)]

Colace Clear: 50 mg [DSC] [dye free]

DocQLace: 100 mg [DSC] [contains fd&c red #40, fd&c yellow #6 (sunset yellow)]

Docu Soft: 100 mg [DSC]

Docusil: 100 mg

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

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

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

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

Laxa Basic: 100 mg

Sof-Lax: 100 mg [DSC]

Stool Softener: 100 mg

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

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

Stool Softener: 100 mg [stimulant free; contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #6 (sunset yellow)]

Stool Softener: 100 mg, 250 mg [DSC] [stimulant free; contains fd&c red #40, 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]

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 fd&c red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben]

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

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

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

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

Generic: 50 mg/5 mL (10 mL, 473 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, menthol, methylparaben, polyethylene glycol, propylparaben, sodium benzoate]

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

Silace: 60 mg/15 mL (473 mL) [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 [scored; contains sodium benzoate]

Stool Softener: 100 mg [contains sodium benzoate]

Generic: 100 mg

Anatomic Therapeutic Chemical (ATC) Classification

• A06AA02

Generic Available (US)

Yes

Pricing: US

Capsules (Colace Oral)

100 mg (per each): $0.33

Capsules (Docusate Calcium Oral)

240 mg (per each): $0.04 - $0.12

Capsules (Docusate Sodium Oral)

100 mg (per each): $0.02 - $0.12

250 mg (per each): $0.04 - $0.24

Capsules (Docusil Oral)

100 mg (per each): $0.05

Capsules (DOK Oral)

100 mg (per each): $0.04

Capsules (DSS Oral)

250 mg (per each): $0.08

Capsules (Kao-Tin Oral)

240 mg (per each): $0.14

Enema (DocuSol Kids Rectal)

100 mg/5 mL (per each): $2.46

Enema (DocuSol Mini Rectal)

283 mg/5 mL (per each): $2.46

Enema (Enemeez Mini Rectal)

283 mg/5 mL (per mL): $0.45

Liquid (Pedia-Lax Oral)

50 mg/15 mL (per mL): $0.05

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

Tablets (Promolaxin Oral)

100 mg (per each): $0.99

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

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

Pharmacodynamics/Kinetics

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

Excretion: Feces (Gattuso 1994)

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Throat irritation.

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

Dioctyl Calcium Sulfosuccinate; Dioctyl Sodium Sulfosuccinate; Docusate Calcium; Docusate Potassium; Docusate Sodium; DOSS; DSS

References

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

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]

Colace (docusate sodium) [prescribing information]. Stamford, CT: Purdue Products LP; November 2012.

Colace Clear (docusate sodium) [prescribing information]. Stamford CT: Purdue Products LP.

Diocto Liquid 50 mg/5 mL (docusate sodium) [prescribing information]. Livonia, MI: Rugby Laboratories; February 2013.

Diocto Syrup 60 mg/15 mL (docusate sodium) [prescribing information]. Livonia, MI: Rugby Laboratories; April 2013.

Docusate Sodium Extra Strength [prescribing information]. Livonia, MI: Major Pharmaceuticals; October 2019.

DocuSol Kids (docusate sodium) [prescribing information]. Phoenix, AZ: Summit Pharmaceuticals.

DocuSol Mini-Enema (docusate sodium) [prescribing information]. Phoenix, AZ: Alliance Labs.

DOK (docusate sodium) [prescribing information]. Livonia, MI: Major Pharmaceuticals; June 2018.

Dulcolax Stool Softener (docusate sodium) [prescribing information]. Chattanooga, TN: Chattem, Inc; received February 2020.

Enemeez (docusate sodium) [prescribing information]. Phoenix, AZ: Alliance Labs.

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]

Greenhalf JO, Leonard HS. Laxatives in the treatment of constipation in pregnant and breast-feeding mothers. Practitioner. 1973;210(256):259-263.[PubMed 4570522]

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

Kao-Tin (docusate calcium) [prescribing information]. Livonia, MI: Major Pharmaceuticals; January 2015.

Kao Tin capsule (docusate) [prescribing information]. Livonia, MI: Major Pharmaceuticals; March 2015.

Lewis JH, Weingold AB. The use of gastrointestinal drugs during pregnancy and lactation. Am J Gastroenterol. 1985;80(11):912-923.[PubMed 2864852]

McCarter DF, Courtney AU, Pollart SM. Cerumen impaction. Am Fam Physician. 2007;75(10):1523-1528.[PubMed 17555144]

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]

Roerig JL, Steffen KJ, Mitchell JE, Zunker C. Laxative abuse: epidemiology, diagnosis and management. Drugs. 2010;70(12):1487-1503.[PubMed 20687617]

Schindler AM, “Isolated Neonatal Hypomagnesaemia Associated With Maternal Overuse of Stool Softener,” Lancet, 1984, 2(8406):822.[PubMed 6207396]

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]

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]

Stool Softener DC Laxative (docusate calcium) [prescribing information]. Livonia, MI: Rugby Laboratories; April 2013.

Surfak (docusate calcium) [prescribing information]. Chattanooga, TN: Chattem, Inc.

Brand Names: International

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

Last Updated 10/17/20