NORMACOL ® Sterculia rubber

NORMACOL ® is a drug based on Gum sterculia.

THERAPEUTIC GROUP: Laxatives - Bulking laxatives.

Indications NORMACOL ® Sterculia rubber

NORMACOL ® is indicated in the symptomatic treatment of constipation.

Mechanism of action NORMACOL ® Sterculia rubber

NORMACOL ® is a drug based on sterculia gum, obtained by collecting the dried exudate from the stem and branches of Sterculia, a plant native to India.
As a mass-forming laxative, once introduced through the alimentary route, the sterculia gum arrives unaltered in the intestine, being neither digested nor absorbed. Here it is able to retain water in the intestinal lumen, allowing an important increase in fecal mass, with volumes that can even reach 100 times those of departure. This property is not only used for laxative purposes (although it remains the only accepted therapeutic indication to date), but also for dietary purposes, given the possibility of interfering with the absorption of various nutrients and reducing the sensation of appetite.

Studies carried out and clinical efficacy

1. STERCULIA AND CHOLESTEROL

Nutr Res. 2009 May; 29: 350-4.

Karaya root saponin exerts a hypocholesterolemic response in rats fed a high-cholesterol diet.

Afrose S, Hossain MS, Maki T, Tsujii H.

Recent studies are trying to characterize the effects of some natural substances, such as the saponins contained in sterculia. Experimental evidence has shown how this plant, due to the presence of both fibers and saponins, can exert a lipid-lowering action by reducing the dietary absorption of cholesterol.

2. STERCULIA RUBBER AND Diarrhea

Colloids Surf B Biointerfaces. 2011 Feb 1; 82: 325-32. Epub 2010 Sep 21.

Design of sterculia gum based double potential antidiarrheal drug delivery system.

Singh B, Sharma N.

The ability of sterculia gum to retain water in the intestinal lumen, and to absorb it in the presence of watery stools, means that this particular fiber is also useful in the treatment of non-specific diarrhea. That is why various groups are looking for a formulation that can significantly enhance this effect.

3. RUBBER STERCULIA AND PHARMACOKINETICS

Biomacromolecules. 2009 Sep 14; 10: 2515-32.

Mechanistic implication for cross-linking in sterculia-based hydrogels and their use in GIT drug delivery.

Singh B, Sharma N.

Sterculia gum is a widely used fiber in the treatment of diverticulitis. In addition to its pharmacodynamic characteristics, this compound also owes much of its success to its pharmacokinetic characteristics, which make it one of the most widely used excipients in the formulation of prolonged-release gastro-resistant tablets.

Method of use and dosage

NORMACOL ® 10 g sachets containing 6.1 g of sterculia rubber: the recommended dosage in the symptomatic treatment of constipation involves taking 2-4 sachets per day, to be taken after meals with plenty of water. The laxative effects are enhanced by a diet rich in liquids, which can contribute to the formation of fecal mass .
It is advisable to start therapy with the lowest possible dosage, to possibly foresee an increase in case of reduced therapeutic efficacy.
The use of this medicine should not be prolonged for several days without the advice of your doctor; therefore, taking NORMACOL ® is only found in the treatment of occasional episodes of constipation.

Warnings NORMACOL ® Sterculia rubber

The intake of NORMACOL ® should be preceded and accompanied by compliance with food standards useful for improving the patient's intestinal health, so as to be able to resort to the use of laxatives only in case of acute episodes of constipation (see diet for constipation) .
Prolonged administration of these medicines could be associated with the onset of profuse diarrhea, dehydration, hypokalemia, reduced intestinal motility, up to total atony and relative chronic constipation.
Although NORMACOL ® can be sold without a prescription, it would still be necessary to consult your doctor before use, especially for patients suffering from endocrine-metabolic and cardiovascular diseases.
NORMACOL ® does not interfere with the normal ability to drive vehicles and use machines.

PREGNANCY AND BREASTFEEDING

To date, the international scientific literature does not allow to evaluate the safety profile of sterculia gum on the health of the unborn child and newborn, when taken during pregnancy or during the lactation period. However, the absence of intestinal absorption should prevent this compound from interfering with the physiological characteristics of the fetus. Therefore, the advice to resort to the use of laxatives during pregnancy only when really necessary and under strict medical supervision remains valid.

Interactions

The intake of laxatives, in particular of those forming mass, capable not only of increasing the intestinal transit speed, but also of directly interfering with the absorption of nutrients and active ingredients, should take place at least two hours after the intake of other drugs, to avoid absorption interference.

Contraindications NORMACOL ® Gomma sterculia

NORMACOL ® is contraindicated in case of hypersensitivity to the active substance or to one of the excipients.
The use of laxatives is also contraindicated in case of intense abdominal pain, nausea, vomiting, diarrhea, gastro-intestinal affections, even with an acute course, bedridden patients, dehydration and in case of intestinal obstruction.

Undesirable Effects - Side Effects

NORMACOL ® is a well tolerated drug with no particular side effects.
In general, the presence of side effects seems to be associated with the abdominal wall distension effect, which can be accompanied by abdominal pain, cramps and colic, which tend to regress promptly following discontinuation of therapy.
Relevant undesirable effects were observed following the prolonged intake of laxatives, with diarrhea, dehydration, hypokalemia and consequent intestinal atony and loss of the laxative efficacy of the drug.

Note

NORMACOL ® is an OTC drug, therefore it can be sold freely without the need for a medical prescription.

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