REGULAX

GROUPEMENT PHARMACEUTIQUE ALGERIEN
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

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.