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Introduction

VA Class:GA205

ATC Class:A06AA

AHFS Class:

Generic Name(s):

The calcium and sodium salts of docusate are anionic, surface-active agents (surfactants) that have emulsifying and wetting properties and are used as stool softeners.

Dosage and Administration

[Section Outline]

Administration !!navigator!!

Docusate salts are administered orally. The sodium salt of docusate may be administered rectally. 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.

Dosage !!navigator!!

Docusate salts should be administered in doses only large enough to produce softening of the stools. The oral dosage of the docusate salts varies widely according to the severity of the condition and the response of the patient and should be adjusted to individual response.

The usual oral dosage of docusate salts in adults and children older than 12 years of age is 50-360 mg daily. The usual oral dosage is 50-150 mg daily in children 2-12 years of age and 25 mg daily in children younger than 2 years of age. Alternatively, children 3-6 years of age may receive oral docusate sodium dosages of 20-60 mg daily and children younger than 3 years of age may receive 10-40 mg daily. Doses at the higher end of these dosage ranges may be required initially. The drugs may be administered in divided doses but usually one bedtime dose is sufficient. One manufacturer suggests adding 50-100 mg of docusate sodium as an oral liquid (not syrup) to saline or oil retention enemas for rectal use.

Other Information

[Section Outline]

Pharmacokinetics

The extent to which orally administered docusate salts are absorbed has not been determined, but the drugs appear to be absorbed to some extent in the duodenum and jejunum and subsequently excreted in bile. The extent of absorption following rectal administration of docusate sodium is unknown.

Softening of the feces generally occurs within 1-3 days following initiation of oral docusate salt therapy.

Chemistry and Stability

Chemistry !!navigator!!

The calcium and sodium salts of docusate are anionic, surface-active agents that have emulsifying and wetting properties. Docusate calcium occurs as a white, amorphous solid having the characteristic odor of octyl alcohol. The calcium salt is very slightly soluble in water and very soluble in alcohol. Docusate sodium occurs as a white, wax-like, plastic solid having a characteristic odor suggestive of octyl alcohol (but no odor of other solvents) and is sparingly soluble in water and freely soluble in alcohol. Solutions of the sodium salt are clear and have a bitter taste and characteristic odor.

Stability !!navigator!!

Capsules of the docusate salts should be stored in tight containers at 15-30°C; docusate sodium solution should be stored in tight containers, and docusate sodium syrup should be stored in tight, light-resistant containers.

Additional Information

For further information on pharmacology, uses, cautions, drug interactions, and dosage and administration of the stool softeners, see the Cathartics and Laxatives General Statement 56:12.

Preparations

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

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Docusate Calcium (Dioctyl Calcium Sulfosuccinate)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules, liquid-filled

240 mg*

Docusate Calcium Liquid-filled Capsules

Surfak® Liqui-Gels®

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®

Purdue

100 mg*

Colace®

Purdue

Correctol® Soft Gels

Schering-Plough

Docusate Sodium Liquid-filled Capsules

Docusoft® S Softgels®

G&W

DOK®

Major

DOS® Softgels®

Teva

Fleet® Sof-Lax®

Fleet

Phillips'® Liqui-Gels®

Novartis

250 mg*

Docusate Sodium Liquid-filled Capsules

DOK®

Major

DOS® Softgels®

Teva

Solution

10 mg/mL*

Colace® Liquid

Purdue

Diocto® Liquid

Docusate Sodium Liquid

Syrup

16.7 mg/5 mL*

Docusate Sodium Syrup

20 mg/5 mL*

Colace® Syrup

Purdue

Diocto® Syrup

Actavis

Docusate Sodium Syrup

DOK® Syrup

Major

Tablets

100 mg*

Docusate Sodium Syrup

Ex-Lax® Stool Softener Caplets®

Novartis

Rectal

Suspension

283 mg/4 mL

Therevac S.B.® Enema

Jones Pharma

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

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

Jones Pharma

Copyright

AHFS® Drug Information. © Copyright, 1959-2024, Selected Revisions January 1, 2009. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.