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Docusate: Drug information

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

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Colace [OTC];
  • Docu Liquid [OTC] [DSC];
  • Docu [OTC] [DSC];
  • Docusate Mini [OTC];
  • DocuSol Kids [OTC];
  • DocuSol Mini [OTC] [DSC];
  • DOK [OTC];
  • Dulcolax Stool Softener [OTC];
  • Enemeez Mini [OTC];
  • Fleet Stool Softener [OTC];
  • FT Stool Softener [OTC];
  • GoodSense Stool Softener [OTC];
  • Healthy Mama Move It Along [OTC];
  • OneLAX Docusate Sodium [OTC] [DSC];
  • Pedia-Lax [OTC];
  • 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 (Ref).

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function: No dosage adjustment necessary for any degree of kidney impairment (limited systemic absorption) (Ref).

Hemodialysis, intermittent (thrice weekly): No dosage adjustment necessary (limited systemic absorption) (Ref).

Peritoneal dialysis: No dosage adjustment necessary (limited systemic absorption) (Ref).

CRRT: No dosage adjustment necessary (limited systemic absorption) (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (limited systemic absorption) (Ref).

Dosing: Liver Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

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

Dosage guidance:

Dosage form information: Docusate is available as two salts, docusate calcium and docusate sodium; approval ages and dosing are specific to each formulation. Docusate may be administered by multiple routes (eg, oral, rectal, otic); use caution.

Constipation, occasional

Constipation, occasional (stool softener):

Oral:

Docusate sodium:

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

Children ≥12 years and Adolescents: Oral: 50 to 300 mg/day in single or divided doses.

Docusate calcium:

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

Rectal:

Docusate sodium:

Children 2 to <12 years: Enema: 100 mg/5 mL: Rectal: 100 mg (1 unit) once daily.

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

Ear wax removal

Ear wax removal: Limited data available: Note: Use not recommended if patient has known or suspected tympanic membrane perforation (Ref).

Infants ≥6 months, Children, and Adolescents: Docusate sodium: Oral liquid: 10 mg/mL: Otic: Instill 1 mL into ear canal of affected ear and allow to dwell for 10 to 15 minutes. Note: In clinical trials, the 50 mg/5 mL liquid product was used (Ref).

Dosing: Kidney Impairment: Pediatric

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

Dosing: Liver Impairment: Pediatric

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

Adverse Reactions

There are no adverse reactions listed in the manufacturer's labeling.

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).

Dosage Forms: US

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

Capsule, Oral, as calcium:

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)]

DOK: 100 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)]

Fleet Stool Softener: 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)]

FT Stool Softener: 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)]

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

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

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 [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 mL)

DocuSol Mini: 283 mg/5 mL (5 ea [DSC])

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

Liquid, Oral, as sodium:

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

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

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

OneLAX Docusate Sodium: 50 mg/5 mL (473 mL [DSC]) [contains methylparaben, propylene glycol, propylparaben, sodium benzoate]

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 [DSC], 473 mL); 100 mg/10 mL (10 mL)

Syrup, Oral, as sodium:

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

Generic: 60 mg/15 mL (25 mL [DSC])

Tablet, Oral, as sodium:

DOK: 100 mg

FT Stool Softener: 100 mg [stimulant free; contains sodium benzoate]

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

Stool Softener: 100 mg

Generic: 100 mg [DSC]

Generic Equivalent Available: US

Yes

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): $0.06 - $0.07

Capsules (DSS Oral)

250 mg (per each): $0.08

Capsules (Fleet Stool Softener Oral)

100 mg (per each): $0.38

Enema (DocuSol Kids Rectal)

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

Enema (Enemeez Mini Rectal)

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

Liquid (Pedia-Lax Oral)

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

Tablets (DOK Oral)

100 mg (per each): $0.05

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.

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: Ensure adequate fluid intake.

Liquid: Shake well. To mask bitter taste and reduce throat irritation, may dilute in a beverage (eg, milk, fruit juice, or other beverage preferred by pediatric patient) or add to applesauce or other food preferred by pediatric patient.

Otic(using Oral Liquid): Shake well. Instill into ear canal and allow to dwell for 10 to 15 minutes with affected ear facing upward, then allow to drain by gravity (Ref).

Rectal: Enema: 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, taking care not to damage rectal wall. Grasp tube firmly and squeeze slowly to empty the contents; keep tube squeezed and remove from rectum. Discard after administration.

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

Dulcolax may be confused with Dulcolax (bisacodyl)

International issues:

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

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Published outcome data following maternal use of docusate during pregnancy are limited (Brigstocke 2022; Heinonen 1977; Jick 1981); however, based on available data, an increased risk to the fetus has not been observed (Brigstocke 2022). Hypomagnesemia was reported in 1 newborn following chronic maternal overuse of docusate sodium throughout pregnancy (Schindler 1984).

Treatment of constipation in pregnant patients is similar to that of nonpregnant patients and medications may be used when diet and lifestyle modifications are not effective. Studies evaluating the effectiveness of docusate for the treatment of constipation during pregnancy are limited; other agents may be preferred (Rao 2022; Turawa 2020; WHO 2022). Because constipation may be caused by components of some prenatal vitamins, docusate has been added to some preparations (Mahadevan 2006).

Breastfeeding Considerations

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

Diarrhea was noted in 1 breastfeeding infant following maternal use of danthron and docusate sodium (Greenhalf 1973).

Although systemic absorption is expected to be minimal, use of agents with no absorption may be preferred in some patients who are breastfeeding (Anderson 2021; Lewis 1985). In general, docusate is considered acceptable for use in breastfeeding patients (Anderson 2021).

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 (Adult Data Unless Noted)

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

Excretion: Feces (Gattuso 1994)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Dewax | Molcer | Waxsol;
  • (AR) Argentina: Cerumex | Clyss-go | Otoclean;
  • (AU) Australia: Apohealth ear wax | Chemists own ear wax removal drops | Coloxyl | Soflax | Waxsol;
  • (BD) Bangladesh: Docuset | Soflax;
  • (CN) China: Yi ke long;
  • (CO) Colombia: Dulcolax comfort;
  • (DO) Dominican Republic: Clyss-go;
  • (EG) Egypt: Egycusate | Sobocusate | Sulfoctyl;
  • (ES) Spain: Dama lax | Tirolaxo;
  • (FI) Finland: Emtix;
  • (FR) France: Jamylene;
  • (GB) United Kingdom: Clear ear | Dioctyl | Dulcoease | Molcer | Waxsol;
  • (HK) Hong Kong: Colace | Hisof | Soflax | Softon | Waxsol;
  • (ID) Indonesia: Forumen | Laxadine | Waxsol;
  • (IE) Ireland: Dioctyl | Waxsol;
  • (IL) Israel: Docusoft;
  • (IN) India: Cellubril | Laxicon | Otosoft | Waxrim;
  • (IT) Italy: Macrolax;
  • (JO) Jordan: Dewax | Waxsol;
  • (KR) Korea, Republic of: Green morning;
  • (KW) Kuwait: Waxsol;
  • (LB) Lebanon: Dewax | Fleet sof lax | Waxsol;
  • (MX) Mexico: Clyss-go | Diocaps | Modaton neo;
  • (MY) Malaysia: Soluwax | Waxsol;
  • (NZ) New Zealand: Coloxyl | Laxofast | Waxsol;
  • (PE) Peru: Clyss-go;
  • (PH) Philippines: Audiwax | Clyss-go | Otoclear | Otosol | Otowax;
  • (PK) Pakistan: Softool;
  • (PL) Poland: Doculax | Laxopol | Ulgix laxi;
  • (PR) Puerto Rico: Colace | Colace clear | Diocto | Docuprene | Docusol | Docusol kids | DOK | Doxinate | Dqzate | Dulcolax Stool Softener | Enemeez kids | Fleet sof lax | Modane soft | Promolaxin | Stool softener | Surfak | Vacuant;
  • (PT) Portugal: Clyss-go;
  • (QA) Qatar: Dewax | Dok | Waxsol;
  • (SA) Saudi Arabia: Dewax | Pms docusate sodium | Waxsol;
  • (SG) Singapore: Soluwax | Waxsol;
  • (TH) Thailand: Colace | Cusate | Dewax | Dioctol | Hemorhin | Pedoc | Waxsol;
  • (TN) Tunisia: Jamylene | Norgalax | Orilyse | Waxsol;
  • (TW) Taiwan: Constipjohn;
  • (UA) Ukraine: Doculac IC;
  • (UY) Uruguay: Clyss-go;
  • (VE) Venezuela, Bolivarian Republic of: Clys go;
  • (ZA) South Africa: Waxsol nf
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