Docusate: Difference between revisions
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|drugClass=OTC Laxative | |drugClass=OTC Laxative | ||
|indicationType=treatment | |indicationType=treatment | ||
|indication=constipation | |indication=[[constipation]] | ||
|adverseReactions=Stomach pain, diarrhea, or cramping | |adverseReactions=[[Stomach pain]], [[diarrhea]], or [[cramping]] | ||
| Line 33: | Line 33: | ||
<!--FDA-Labeled Indications and Dosage (Pediatric)--> | <!--FDA-Labeled Indications and Dosage (Pediatric)--> | ||
|fdaLIADPed=====Dosage==== | |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. | * 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. | |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | ||
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<!--Contraindications--> | <!--Contraindications--> | ||
|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. | |||
< | |||
|warnings=* | |||
* 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--> | <!--Adverse Reactions--> | ||
<!--Clinical Trials Experience--> | <!--Clinical Trials Experience--> | ||
|clinicalTrials= | |clinicalTrials=[[Stomach pain]], [[diarrhea]], or [[cramping]] | ||
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | |postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | ||
<!--Drug Interactions--> | <!--Drug Interactions--> | ||
|drugInteractions=* | |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--> | <!--Use in Specific Populations--> | ||
| Line 195: | Line 76: | ||
<!--Administration and Monitoring--> | <!--Administration and Monitoring--> | ||
|administration=* Oral | |administration=* Oral | ||
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | |||
<!--IV Compatibility--> | <!--IV Compatibility--> | ||
| Line 205: | Line 84: | ||
<!--Overdosage--> | <!--Overdosage--> | ||
|overdose= | |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--> | <!--Pharmacodynamics--> | ||
| Line 243: | Line 117: | ||
<!--How Supplied--> | <!--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=<!--Patient Counseling Information--> | |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. | |fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label. | ||
| Line 251: | Line 143: | ||
<!--Brand Names--> | <!--Brand Names--> | ||
|brandNames=* | |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--> | <!--Look-Alike Drug Names--> | ||
|drugShortage= | |drugShortage= | ||
}} | }} | ||
<!--Pill Image--> | <!--Pill Image--> | ||
Latest revision as of 19:16, 6 April 2015
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
- 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.