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Docusate


General


Pronunciation

(DOK yoo sate)


Brand Names: U.S.

  • Colace Clear [OTC]
  • Colace [OTC]
  • D.O.S. [OTC] [DSC]
  • Diocto [OTC]
  • Doc-Q-Lace [OTC] [DSC]
  • DocQLace [OTC]
  • Docu Soft [OTC]
  • Docu [OTC]
  • Docuprene [OTC]
  • Docusil [OTC]
  • DocuSol Kids [OTC]
  • DocuSol Mini [OTC]
  • DOK [OTC]
  • Dulcolax Stool Softener [OTC]
  • Enemeez Mini [OTC]
  • Healthy Mama Move It Along [OTC]
  • Kao-Tin [OTC]
  • KS Stool Softener [OTC]
  • Laxa Basic [OTC]
  • Pedia-Lax [OTC]
  • Promolaxin [OTC]
  • Silace [OTC]
  • Sof-Lax [OTC]
  • Stool Softener Laxative DC [OTC] [DSC]
  • Stool Softener [OTC]
  • Sur-Q-Lax [OTC] [DSC]
  • Vacuant Mini-Enema [OTC] [DSC]

Indications


Use: Labeled Indications

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


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)


Dosing and Administration


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)


Dosing: Geriatric

Refer to adult dosing.


Dosing: Pediatric

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

Stool softener:

Oral:

Docusate calcium: Children ≥12 years and Adolescents: Refer to adult dosing.

Docusate sodium:

Children 2 to <12 years: 50 to 150 mg once daily or in divided doses

Children ≥12 years and Adolescents: Refer to adult dosing.

Rectal:

Children 2 to <12 years:

100 mg per 5 mL: 100 mg (1 enema) once daily

283 mg per 5 mL: 283 mg (1 enema) once daily

Children ≥12 years and Adolescents: 283 mg per 5 mL: Refer to adult dosing.

Ceruminolytic (off-label use): Children and Adolescents: 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: Renal Impairment

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


Dosing: Hepatic Impairment

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


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.

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.


Dietary Considerations

Some products may contain sodium.


Storage

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


Dosage Forms/Strengths


Dosage Forms

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)]

Kao-Tin: 240 mg [DSC] [sodium free; contains fd&c red #40]

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

Stool Softener Laxative DC: 240 mg [DSC] [contains fd&c red #40]

Sur-Q-Lax: 240 mg [DSC]

Generic: 240 mg

Capsule, Oral, as sodium:

Colace: 50 mg [DSC]

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

Colace Clear: 50 mg [dye free]

D.O.S.: 250 mg [DSC]

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

Docu Soft: 100 mg

Docusil: 100 mg

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

DOK: 250 mg [DSC]

DOK: 250 mg [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)]

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

Stool Softener: 100 mg

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

Generic: 100 mg, 250 mg

Enema, Rectal, as sodium:

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

DocuSol Mini: 283 mg (5 ea)

Enemeez Mini: 283 mg (5 mL)

Vacuant Mini-Enema: 283 mg (5 mL [DSC])

Liquid, Oral, as sodium:

Diocto: 50 mg/5 mL (473 mL) [contains fd&c red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben; vanilla flavor]

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)

Syrup, Oral, as sodium:

Diocto: 60 mg/15 mL (473 mL) [contains fd&c red #40, menthol, methylparaben, polyethylene glycol, propylparaben, sodium benzoate; peppermint flavor]

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

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

Doc-Q-Lace: 60 mg/15 mL (473 mL [DSC]) [contains alcohol, usp, fd&c red #40, methylparaben, propylene glycol, propylparaben, 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 [contains sodium benzoate]

DOK: 100 mg [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


Drug 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.


Adverse Reactions


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 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.


Pregnancy Considerations

The short-term use of docusate for the treatment of constipation is generally considered safe during pregnancy (Mahadevan 2006). Hypomagnesemia was reported in a newborn following chronic maternal overuse throughout pregnancy (Schindler 1984).


Actions


Pharmacology

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)


Excretion

Feces (Gattuso 1994)


Onset of Action

Oral: 12 to 72 hours; Rectal: 2 to 15 minutes


Patient and Family Education


Patient Education

- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

- Patient may experience abdominal cramps. Have patient report immediately to prescriber rectal irritation (HCAHPS).

- Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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