Docusate Salts

Class: Cathartics and Laxatives
ATC Class: A06AA
VA Class: GA205
CAS Number: 128-49-4
Brands: Colace, Correctol, Diocto, Docusoft S, DOK, DOS, Ex-Lax Stool Softener, Fleet Sof-Lax, Gentlax S, Peri-Colace S, Phillips’, Senokot S, Surfak, Therevac Plus Enema, Therevac S.B. Enema

Introduction

Stool softeners (emollients); anionic, surface-active agents (surfactants) that have emulsifying and wetting properties.b c

Uses for Docusate Salts

Constipation

Used as stool softeners (emollients) to relieve occasional constipation.a c e

Preferred to bulk-forming laxatives to ease evacuation of feces in constipation associated with hard, dry stools.c

Considered the treatment of choice by many clinicians for childhood constipation associated with hard, dry stools and to be safer and more efficacious than mineral oil for conditions in which straining at defecation is to be avoided.c

Particularly useful prophylactically for softening stools and preventing painful defecation in patients who have or are about to undergo hemorrhoid surgery or who have other anorectal disorders or when it is desirable to avoid straining at defecation (e.g., following abdominal surgery, recent rectal surgery, or myocardial infarction; in patients with vascular diseases, diseases of the anus or rectum, or hernias; immediately postpartum).c e

Used as stool softeners for constipation associated with stricture of the colon.c

Used to soften fecal impactions.c Safer and more efficacious than mineral oil.c After softening the impacted feces with a stool softener, stimulant or saline laxatives may be administered rectally to evacuate the impacted colon.c

Used in combination with stimulant laxatives (e.g., senna, bisacodyl) for long-term management of opiate-induced constipation.e

Docusate Salts Dosage and Administration

Administration

Docusate salts are administered orally and the sodium salt also is administered rectally.a b

Adequate fluid intake facilitates stool softening.e

Oral Administration

Administer orally.a b

Dilution

Oral liquids (not syrups) of docusate sodium should be diluted with 120 mL of milk, fruit juice, or infant formula to mask their bitter taste.b

Rectal Administration

The sodium salt of docusate may be administered rectally.b

Dosage

Administered in doses only large enough to produce softening of the stools.b

Oral dosage varies widely according to the severity of the condition and the response of the patient and should be adjusted to individual response.b

Pediatric Patients

Constipation

May be administered in divided doses, but usually one bedtime dose is sufficient.b

Initially, doses at the higher end of the dosage ranges may be required.b

Oral

Children <2 years of age: Usually, 25 mg (range: 20–50 mg) daily.b e

Children 2–12 years of age: Usually, 50–150 mg daily.b e

Children >12 years of age: Usually, 50–360 mg daily.b e

Oral, Alternative Dosing (e.g., Liquid Formulations)

Children <3 years of age: 10–40 mg daily.e

Children 3–6 years of age: 20–60 mg daily.b e

Children 6–12 years of age: 40–150 mg daily.b e

Rectal

Add 50–100 mg of docusate sodium as an oral liquid (not syrup) to saline or oil retention enemas for rectal use.b

Adults

Constipation
Oral

Usually, 50–360 mg daily.b e

Oral, Alternative Dosing (e.g., Liquid Formulations)

50–500 mg daily.

Rectal

Add 50–100 mg of docusate sodium as an oral liquid (not syrup) to saline or oil retention enemas for rectal use.b

Special Populations

Hepatic Impairment

No specific dosage recommendations for hepatic impairment.a b

Renal Impairment

No specific dosage recommendations for renal impairment.a b

Geriatric Patients

No specific geriatric dosage recommendations.a

Cautions for Docusate Salts

Contraindications

  • In acute abdominal pain, nausea, vomiting, or other symptoms of appendicitis or undiagnosed abdominal pain.c e

Warnings/Precautions

General Precautions

Chronic Use or Overdosage

Chronic use or overdosage of laxatives may produce persistent diarrhea, hypokalemia, loss of essential nutritional factors, and dehydration.c

Mainly associated with stimulant laxatives, but consider the possibility that laxative dependence, chronic constipation, and loss of normal bowel function could occur with any laxative during long-term use.c

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Common Adverse Effects

Adverse effects are rare.c Occasionally, mild, transitory GI cramping pains, diarrhea, or rashes may occur.c e Irritation of the throat following oral administration of docusate sodium solutions.c

Interactions for Docusate Salts

GI Drug Absorption

Docusate salts, which are surface-active agents (surfactants), theoretically may enhance the absorption of many orally administered drugs.c e The surfactant properties potentially could facilitate transport of other substances across cell walls.e

Some clinicians recommend that stool softeners not be administered concurrently with any oral drugs having low therapeutic indices.

Specific Drugs

Drug

Interaction

Comments

Aspirin

Potentiates aspirin-induced intestinal mucosal damagec e

Use concomitantly with cautione

Mineral oil

Increased GI absorption of mineral oilc e

Avoid concomitant usec

Docusate Salts Pharmacokinetics

Absorption

Bioavailability

Not determined, but docusate salts appear to be absorbed to some extent in the duodenum and jejunum and subsequently excreted in bile.b

Extent of absorption following rectal administration of docusate sodium is unknown.b

Onset

Fecal softening generally occurs within 1–3 days.b

Generally produces a bowel movement in 12–72 hours, but occasionally may take up to 3–5 days.a e

Duration

About 72 hours.e

Stability

Storage

Oral

Capsules

Capsules of the docusate salts should be stored in tight containers at 25°C (may be exposed to 15–30°C) .a b d Storage of liquid-filled capsules also should include a dry place.d

Solutions and Syrups

Solutions in tight containers.b d

Syrups in tight, light-resistant containers.b d

Tablets

Well-closed containers.d

Actions

  • Anionic, surface-active (surfactant) agents that have emulsifying and wetting properties.b

  • Soften fecal material and ease defecation by lowering surface tension at the oil-water interface of fecal material, permitting water and lipids to penetrate.c

  • Laxative properties may result from stimulation of electrolyte and water secretion in the colon.c

  • May alter the permeability of colonic mucosal cells and mediate active ion secretion thereby producing net fluid accumulation and laxative action.c

Advice to Patients

  • Importance of adequate fluid intake to facilitate stool softening.e

  • Importance of not using laxative products for a period longer than 1 week unless directed by a clinician.a c

  • Importance of informing clinicians before use if abdominal pain, nausea, or vomiting is present or if a sudden change in bowel habits that persists over a period of 2 weeks has been noticed.a c

  • Importance of informing clinicians before use if currently taking mineral oil.a

  • Importance of stopping use and informing a clinician if rectal bleeding occurs or a bowel movement fails to occur after use.a These could be signs of a serious condition.a

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Docusate Calcium (Dioctyl Calcium Sulfosuccinate)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules, liquid-filled

240 mg*

Surfak Liqui-Gels (with parabens)

Pfizer

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Docusate Sodium (Dioctyl Sodium Sulfosuccinate, DOSS, DSS)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder*

Oral

Capsules, liquid-filled

50 mg

Colace (with propylene glycol)

Purdue

100 mg*

Colace (with parabens and propylene glycol)

Purdue

Correctol Soft Gels (with propylene glycol)

Schering-Plough

Docusoft S Softgels

G&W

DOK

Major

DOS Softgels

IVAX

Fleet Sof-Lax

Fleet

Phillips’ Liqui-Gels (with parabens and propylene glycol)

Novartis

250 mg*

DOK

Major

DOS Softgels

IVAX

Solution

10 mg/mL*

Colace Liquid (with parabens and propylene glycol; with calibrated dropper)

Purdue

Diocto Liquid

Alpharma, Major, Rugby, IVAX

Docusate Sodium Liquid

Morton Grove, Pharmaceutical Associates

Syrup

16.7 mg/5 mL

Docusate Sodium Syrup

Roxane

20 mg/5 mL*

Colace Syrup (with ≤1% alcohol and parabens)

Purdue

Diocto Syrup

Alpharma, Rugby, IVAX

Docusate Sodium Syrup

Morton Grove, Pharmaceutical Associates

DOK Syrup

Major

Tablets

100 mg*

Ex-Lax Stool Softener Caplets (with methylparaben)

Novartis

Rectal

Suspension

283 mg/4 mL

Therevac S.B. Enema (with glycerin and green soap)

Jones Pharma

Docusate Sodium Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

50 mg with Standardized Senna Concentrate (sennosides 8.6 mg)

Gentlax S

Purdue Frederick

Peri-Colace

Purdue

Senokot S

Purdue Frederick

Rectal

Suspension

283 mg/4 mL with Benzocaine 20 mg/4 mL

Therevac Plus Enema (with glycerin and green soap)

Jones Pharma

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Colace 100MG Capsules (PURDUE PRODUCTS LP): 60/$26.99 or 120/$43.97

Doc-Q-Lace 100MG Capsules (QUALITEST): 100/$13.99 or 200/$16.97

Docusate Sodium 100MG Capsules (RUGBY): 1000/$27.99 or 2000/$45.97

Docusate Sodium 250MG Capsules (RUGBY): 100/$15.99 or 200/$22.98

Senna-Docusate Sodium 8.6-50MG Tablets (RUGBY): 100/$12.99 or 300/$16.98

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions May 1, 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. Purdue Products, L.P. Colace(docusate sodium) prescribing information. Stamford, CT: 2003.

b. AHFS Drug Information 2004. McEvoy, GK, ed. Stool softeners. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2780-81.

c. AHFS Drug Information 2004. McEvoy, GK, ed. Cathartics and laxatives general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2769-73

d. The United States pharmacopeia, 27th rev, and The national formulary, 22nd ed. Rockville, MD: The United States Pharmacopeial Convention, Inc; 2004:653-8.

e. American Pharmaceutical Association. Handbook of nonprescriptin drugs. 14th ed. Washington, DC: American Pharmaceutical Association; 2004:378,381.

Hide
(web1)