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
ActionsActions
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
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
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 |
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 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Senna Lax 8.6MG Tablets (QUALITEST): 1000/$39.99 or 3000/$99.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions May 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.
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