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'''Docusate''' ({{pronEng|ˈdɒkjuːseɪt}}) is the generic name of a [[surfactant]] used as a [[laxative]] and [[stool softener]], which is sold in the U.S. under multiple brand names: Aqualax, Calube, Colace, Colace Micro-Enema, Correctol Softgel Extra Gentle, DC-240, Dialose, Diocto, Dioctocal, Dioctosoftez, Dioctyn, Dionex, Doc-Q-Lace, Docu Soft, Docucal, Doculax, Docusoft S, DOK, DOS, Doss-Relief, DSS, Dulcolax, Ex-Lax Stool Softener, Fleet Sof-Lax, Genasoft, Kasof, Laxa-basic, Modane Soft, Octycine-100, Regulax SS, Sulfalax Calcium, Sur-Q-Lax, Surfak Stool Softener and Therevac-SB.
{{DrugProjectFormSinglePage
|authorTag=<!--Overview-->{{RB}}
|OTC=Yes
|genericName=Docusate sodium
|aOrAn=a
|drugClass=OTC Laxative
|indicationType=treatment
|indication=[[constipation]]
|adverseReactions=[[Stomach pain]], [[diarrhea]], or [[cramping]]


Docusate is also any of a group of anionic surfactants widely used as emulsifying, wetting, and dispersing agents.


==Clinical use==
<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>


Docusate is given to make stools softer and easier to pass.  It is used to treat [[constipation]] due to hard stools, in painful anorectal conditions such as [[hemorrhoids]], and for people who should avoid straining during bowel movements.  Of note is that the effect of docusate may not necessarily be all due to its surfactant properties.  [[Perfusion]] studies suggest that docusates inhibit fluid absorption or stimulate secretion in jejunum.


While the use of docusate is widespread, the data to support its efficacy in treating chronic constipation is actually lacking.  Also, although more research is needed, long term use of docusate seems to decrease levels of magnesium and potassium in the blood.


Docusate should not be used in addition to mineral oil as the emulsifier will result in mineral oil being absorbed rather than functioning as a lubricant for the bowel walls.
<!--Adult Indications and Dosage-->


==Presentations==
<!--FDA-Labeled Indications and Dosage (Adult)-->
*Docusate is available in tablet, [[capsule]], liquid, and rectal [[enema]].
|fdaLIADAdult=====Indications====
*Docusate calcium [USP] and docusate potassium [USP] are anionic surfactants used as stool softeners and are administered orally.
* For the relief of occasional constipation due to hard stools. The effect on stools is usually apparent 1 to 3 days after the first dose.
*Docusate sodium [USP] is anionic surfactant used as a stool softener and is administered orally or rectally; as a tablet disintegrant or as an emulsifier and dispersant in topical preparations.  When sold as Colace, it is docusate sodium, or sodium salt of [[dioctyl]] [[sodium sulfosuccinate]] (DSS).  Some metabolism studies show that DSS is absorbed by the body from the gastrointestinal tract, undergoing extensive metabolism. In humans, the main way DSS metabolites are excreted is via the feces.


Docusate sodium may be used in a daily regimine in persons who are undergoing narcotic pain medication therapy to reduce the effects of chronic constipation or hardened stools which can cause severe straining, impaction, and torn rectal tissues.
====Dosage====
* As directed by a physician or once daily as follows: Adults and children 12 years of age and over: oral dosage is 5 to 20 mL (1 to 4 teaspoonfuls). Children 6 to under 12 years of age: oral dosage is 5 to 10 mL (1 to 2 teaspoonfuls). Children 3 to under 6 years of age: oral dosage is 2.5 to 5 mL (1⁄2 to 1 teaspoonful). Children under 3 years of age: consult a physician. The higher doses are recommended for initial therapy. Dosage should be adjusted to individual response. If desired, the product may be administered in a 6 to 8 oz glass of milk or fruit juice or in infant formula to mask the bitter taste.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


==Effect==
<!--Non–Guideline-Supported Use (Adult)-->
*The effect on stools is seen 1 to 3 days after the first dose.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


{{Laxatives}}
<!--Pediatric Indications and Dosage-->


[[Category:Laxatives]]
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed=====Dosage====
* As directed by a physician or once daily as follows: Adults and children 12 years of age and over: oral dosage is 5 to 20 mL (1 to 4 teaspoonfuls). Children 6 to under 12 years of age: oral dosage is 5 to 10 mL (1 to 2 teaspoonfuls). Children 3 to under 6 years of age: oral dosage is 2.5 to 5 mL (1⁄2 to 1 teaspoonful). Children under 3 years of age: consult a physician. The higher doses are recommended for initial therapy. Dosage should be adjusted to individual response. If desired, the product may be administered in a 6 to 8 oz glass of milk or fruit juice or in infant formula to mask the bitter taste.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


{{pharma-stub}}
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
|contraindications=There is limited information regarding <i>Contraindications</i> of {{PAGENAME}} in the drug label.
|warnings=* Do not use laxative products when [[abdominal pain]], [[nausea]], or [[vomiting]] are present, or use for a period longer than 1 week, unless directed by a physician. If you have noticed a sudden change in bowel habits that persists over a period of 2 weeks, consult a physician before using a laxative. Rectal bleeding or failure to have a bowel move- ment after the use of a laxative may indicate a serious condition. Discontinue use and consult your physician. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. May cause rash in some cases.
 
* KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
 
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
|clinicalTrials=[[Stomach pain]], [[diarrhea]], or [[cramping]]
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
 
 
 
<!--Drug Interactions-->
|drugInteractions=* Do not take this product if you are presently taking mineral oil or a prescription drug, unless directed by a physician.
 
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
|administration=* Oral
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
 
 
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
<!--Overdosage-->
|overdose=There is limited information regarding <i>Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
|drugBox=: [[File:Docusate Wiki Str.png|thumb|none|600px|This image is provided by the Wikipedia.]]
 
 
<!--Mechanism of Action-->
|mechAction=<!--Structure-->
|structure=* Each 5 mL (teaspoonful) contains docusate sodium 50 mg.
 
=====Inactive Ingredients=====
 
* Citric acid, D&C Red No. 33, flavoring, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.
 
* Sodium Content: 14 mg/5 mL.
 
 
 
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
 
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
 
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 
<!--How Supplied-->
|storage=* Keep tightly closed. Store at controlled room temperature, 20° to 25°C (68° to 77°F). Protect from freezing. Protect from light.
|packLabel=====PRINCIPAL DISPLAY PANEL====
Docusate Sodium Liquid
 
100 mg/ 10mL
 
Stool Softener Laxative
 
5 Cups
 
: [[File:Docusate PDP.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
====Ingredients and Appearance====
 
: [[File:Docusate Ing and App.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
 
 
 
<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
 
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
<!--Brand Names-->
|brandNames=* DOCUSATE SODIUM®<ref>{{Cite web | title = DOCUSATE SODIUM | url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0f385e4b-00f5-403a-9952-3c847dba742f}}</ref>
 
<!--Look-Alike Drug Names-->
|drugShortage=
}}
<!--Pill Image-->
 
 
 
<!--Label Display Image-->
 
 
 
 
 
<!--Category-->
 
[[Category:Drug]]

Latest revision as of 19:16, 6 April 2015

Docusate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Docusate is a OTC Laxative that is FDA approved for the treatment of constipation. Common adverse reactions include Stomach pain, diarrhea, or cramping.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • For the relief of occasional constipation due to hard stools. The effect on stools is usually apparent 1 to 3 days after the first dose.

Dosage

  • As directed by a physician or once daily as follows: Adults and children 12 years of age and over: oral dosage is 5 to 20 mL (1 to 4 teaspoonfuls). Children 6 to under 12 years of age: oral dosage is 5 to 10 mL (1 to 2 teaspoonfuls). Children 3 to under 6 years of age: oral dosage is 2.5 to 5 mL (1⁄2 to 1 teaspoonful). Children under 3 years of age: consult a physician. The higher doses are recommended for initial therapy. Dosage should be adjusted to individual response. If desired, the product may be administered in a 6 to 8 oz glass of milk or fruit juice or in infant formula to mask the bitter taste.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Docusate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Docusate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Dosage

  • As directed by a physician or once daily as follows: Adults and children 12 years of age and over: oral dosage is 5 to 20 mL (1 to 4 teaspoonfuls). Children 6 to under 12 years of age: oral dosage is 5 to 10 mL (1 to 2 teaspoonfuls). Children 3 to under 6 years of age: oral dosage is 2.5 to 5 mL (1⁄2 to 1 teaspoonful). Children under 3 years of age: consult a physician. The higher doses are recommended for initial therapy. Dosage should be adjusted to individual response. If desired, the product may be administered in a 6 to 8 oz glass of milk or fruit juice or in infant formula to mask the bitter taste.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Docusate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Docusate in pediatric patients.

Contraindications

There is limited information regarding Contraindications of Docusate in the drug label.

Warnings

  • Do not use laxative products when abdominal pain, nausea, or vomiting are present, or use for a period longer than 1 week, unless directed by a physician. If you have noticed a sudden change in bowel habits that persists over a period of 2 weeks, consult a physician before using a laxative. Rectal bleeding or failure to have a bowel move- ment after the use of a laxative may indicate a serious condition. Discontinue use and consult your physician. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. May cause rash in some cases.
  • KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Adverse Reactions

Clinical Trials Experience

Stomach pain, diarrhea, or cramping

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Docusate in the drug label.

Drug Interactions

  • Do not take this product if you are presently taking mineral oil or a prescription drug, unless directed by a physician.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Docusate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Docusate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Docusate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Docusate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Docusate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Docusate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Docusate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Docusate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Docusate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Docusate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Docusate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral

Monitoring

There is limited information regarding Monitoring of Docusate in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Docusate in the drug label.

Overdosage

There is limited information regarding Overdose of Docusate in the drug label.

Pharmacology

This image is provided by the Wikipedia.

Mechanism of Action

There is limited information regarding Docusate Mechanism of Action in the drug label.

Structure

  • Each 5 mL (teaspoonful) contains docusate sodium 50 mg.
Inactive Ingredients
  • Citric acid, D&C Red No. 33, flavoring, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.
  • Sodium Content: 14 mg/5 mL.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Docusate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Docusate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Docusate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Docusate in the drug label.

How Supplied

There is limited information regarding Docusate How Supplied in the drug label.

Storage

  • Keep tightly closed. Store at controlled room temperature, 20° to 25°C (68° to 77°F). Protect from freezing. Protect from light.

Images

Drug Images

{{#ask: Page Name::Docusate |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL

Docusate Sodium Liquid

100 mg/ 10mL

Stool Softener Laxative

5 Cups

This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

{{#ask: Label Page::Docusate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Docusate in the drug label.

Precautions with Alcohol

  • Alcohol-Docusate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • DOCUSATE SODIUM®[1]

Look-Alike Drug Names

There is limited information regarding Docusate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "DOCUSATE SODIUM".
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