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OTC

REGULAX

0,12G/10G/Rectal Gel/DOCUSATE SODIQUE
GROUPEMENT PHARMACEUTIQUE ALGERIEN
ManufacturerVerified lab

GROUPEMENT PHARMACEUTIQUE ALGERIEN

Public retail price
630.00DZD

Identification

Active ingredient (INN)
DOCUSATE SODIQUE
Internal code
10 M 063
Country of Origin
Algeria
Pharmaceutical form
Rectal Gel
Prescription List
OTC
Packaging
b/06tubes canules de 10g
REGULAX
Clinical View

DAWA Clinical Workbench v2.0

Information may not be accurate. Always consult a physician, pharmacist, or specialist before acting on any data shown here.

Description

Docusate, or dioctyl sulfosuccinate, is a stool softener indicated for the treatment of constipation 1.

Docusate acts by increasing the amount of water the stool absorbs in the gut, making the stool softer and easier to pass 7.

Docusate can be

Oral or rectally administered.

Docusate is on the World Health

Organization's List of Essential Medicines 10.

However the effectiveness of docusate in treating constipation remains unclear, as several studies report docusate to be no more effective than placebo for increasing the frequency of stool or stool softening 6, 2, 5.

Recently there has been pressure to stop prescribing docusate as it has been identified as an ineffective medicine 3, 5, 9.

Additionally, it does not appear to lessen symptoms associated with constipation such as abdominal cramps.

Still docusate is available in over-the-counter products as a common laxative.

Indications

Indicated for the treatment of constipation associated with dry, hard stools or opioid induced constipation 4.

Though recently, pressure has been building to end the use of docusate over concerns of efficacy 3, 5, 9.

Pharmacodynamics

Docusate sodium is a laxative and an anionic detergent that supposedly promotes incorporation of water and fats into stool through a reduction in surface tension, resulting in softer fecal mass 7, 4.

Docusate's onset of action is 6-72 hours Oral and 2-15 minutes rectally 7, 8.

The effects of docusate are thought to be exerted locally in the jejunum 1.

Mechanism of Action

Recent studies suggest that docusate's mechanism of action is due largely to it's surfactant effect in the intestines, which allow fat and water into the feces to soften the stool 4.

Docusate's mechanism of action was investigated in on healthy patients.

Docusate was added directly to the jejunum based on calculated concentrations of docusate in the jejunum.

At this concentration, there was an increase in secretion of water, sodium, chloride, and potassium as well as a decrease in absorption of glucose and bicarbonate 1.

Based on in vitro data, the authors suggested this effect was due to an increase in intracellular cyclic AMP either directly through docusate or E series prostaglandins.

Absorption

Docusate is not absorbed systemically 7, 9.

As the actions of docusate are local and it is not absorbed, the pharmacokinetic parameters are not available 9.

Route of Elimination

If docusate is systemically absorbed, it undergoes biliary excretion 7, 9.

Adverse Effects

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Toxicity

Docusate is not known to be carcinogenic or cause reproductive toxicity.

It was not mutagenic in the Ames assay MSDS.

Acute oral

LD50 in rat is 1900 mg/kg MSDS.

Warnings

Do not use if you are presently taking mineral oil, unless told to do so by a doctor Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after use of a laxative.

These could be signs of a serious condition. you need to use a stool softener laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Take only by mouth.

Doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over take 1-3 softgels daily children to under 12 years of age take 1 softgel daily children under 2 years ask a doctor.

Storage & Handling

Other information each softgel contains: sodium 6 mg VERY LOW SODIUM store at 25 o C (77 o F); excursions permitted between 15 o -30 o C (59 o -86 o F). keep tightly closed.

Alternatives