Version November 2024
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 (Ref).
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).
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
(For additional information see "Docusate: Pediatric drug information")
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 (Ref).
Age-directed (fixed) dosing:
Infants ≥6 months and Children <2 years: 12.5 mg 3 times daily (Ref).
Children ≥2 and Adolescents: 40 to 150 mg/day in 1 to 4 divided doses (Ref); in children ≥12 years and adolescents, doses up to 500 mg/day divided may be used (Ref).
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.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no adverse reactions listed in the manufacturer's labeling.
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.
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).
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] [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)]
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)]
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 [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)
Enemeez Kids Mini Enema: 100 mg/5 mL (5 mL) [contains polyethylene glycol (macrogol)]
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 [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) [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); 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:
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]
Promolaxin: 100 mg [DSC] [contains sodium benzoate]
Stool Softener: 100 mg
Generic: 100 mg [DSC]
Yes
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): $0.03 - $0.08
250 mg (per each): $0.06 - $0.26
Capsules (DSS Oral)
250 mg (per each): $0.08
Enema (DocuSol Kids Rectal)
100 mg/5 mL (per mL): $0.86
Enema (DocuSol Mini Rectal)
283 mg/5 mL (per each): $4.30
Enema (Enemeez Kids Mini Enema Rectal)
100 mg/5 mL (per mL): $0.86
Enema (Enemeez Mini Rectal)
283 mg/5 mL (per mL): $0.78
Liquid (OneLAX Docusate Sodium Oral)
50 mg/5 mL (per mL): $0.03
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): $0.05
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.
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.
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
Stool softener: Prevention of straining during defecation and constipation associated with hard, dry stools; relief of occasional constipation
Ceruminolytic
Colace may be confused with Calan, Cozaar
Dulcolax may be confused with Dulcolax (bisacodyl)
Docusate may be confused with Doxinate brand name for doxylamine and pyridoxine [India]
None known.
There are no known significant interactions.
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).
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).
Some products may contain sodium.
Rectal: Periodic rectal exams are recommended in patients with impaired rectal function, especially loss of sensation.
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).
Onset of action: Oral: 12 to 72 hours; Rectal: 2 to 15 minutes
Excretion: Feces (Gattuso 1994)
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