XPREP ® Concentrated Senna Extract

XPREP ® is a drug based on concentrated senna extracts.

THERAPEUTIC GROUP: Laxatives - Contact laxative (stimulant).

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications XPREP ® Concentrated Senna extract

XPREP ® is indicated for the symptomatic treatment of occasional constipation.

Mode of action XPREP ® Concentrated Senna extract

The active ingredient contained in the XPREP ® drug is represented by particular derivatives belonging to the family of anthraquinone glycosides (sennosoids), extracted directly from the senna, a plant known for its important medicinal properties. Taken orally, the sennosoids cross the alimentary canal and are absorbed only minimally by the duodenal mucosa, so that the metabolites found in the urine represent only 3.6% of the total; largely, however, they are metabolized by the bacterial flora of the large intestine, with the production of a particularly active metabolite, known as reina. This derivative of sennosoids is able to exert a direct action at the level of the intestinal mucosa, influencing the motility of the colon, increasing its peristalsis and thus guaranteeing an acceleration of intestinal transit and a reduction in the absorption of liquids, keeping the faeces hydrated . These processes are carried out at a fairly long time, between 7 and 10 hours.

About 90% of the sennosoids will be found in the faeces in the form of polymers, indicating the low level of systemic absorption of the product.

Studies carried out and clinical efficacy

1. SENNA AND CONSTIPATION

The administration of senna for limited time intervals has proved to be effective and safe in the treatment of functional constipation, showing an increase in the frequency of evacuation, an improvement in stool consistency and a reduction in pain associated with defecation.

2. EXTRACTS OF SENNA AND TOXICITY

Prolonged use of senna extracts for laxative purposes has been associated for some time with the development of histological and functional alterations of the intestinal mucosa. This study, conducted on animal models that were able to administer senna extracts for long periods, denied the aforementioned hypotheses, not highlighting any type of alteration and validating the good safety and tolerability profile of the product.

3. SENNA IN PREGNANCY

Given the absence of clinical trials related to the use of the senna in pregnancy, and of the related side effects, this backward study has allowed us to evaluate the possible appearance of congenital anomalies in pregnant women suffering from constipation treated with senna derivatives. The study did not record any statistical difference regarding the development of newborns with congenital anomalies in pregnant women whether or not they received senna therapy.

Method of use and dosage

XPREP ® powder and solvent for oral solution, 75 ml bottle containing 150 mg of sennosoids : the recommended dose is one or two teaspoons, after reconstituting the drug, to be taken preferably in the evening after the meal so that the laxative effect can take place tomorrow morning.

Treatment should be started with the minimum doses expected, and if necessary increase the dosage within the expected therapeutic range, until the desired effect is obtained.

In case of reduced efficacy or prolonged administration of XPREP ® medical consultation is necessary.

Warnings XPREP ® Concentrated Senna extract

The assumption of laxatives should be preceded by a period of healthy eating and lifestyle, aimed at improving intestinal peristalsis. It should therefore resort to the use of stimulating laxatives exclusively in the case of acute episodes of constipation and in any case for limited periods of time; this recommendation is necessary, given the presence of important side effects, on the health of the intestine and on the electrolyte, which can be observed following the prolonged intake of these drugs.

XPREP ® contains sugars, therefore it would be appropriate to limit its consumption in case of endocrine-metabolic pathologies such as diabetes, for which medical supervision is recommended.

Sennosoids do not interfere with the ability to drive vehicles or use machinery.

PREGNANCY AND BREASTFEEDING

There are currently no comprehensive clinical trials and scientific studies demonstrating the effects on the health of the fetus related to the intake of XPREP ® during the period of pregnancy and lactation. In the light of these data, the drug should be used only and exclusively in case of real need and under strict medical supervision.

Of course XPREP ® is contraindicated in case of hypersensitivity to one of its components.

Interactions

The increase in intestinal transit speed induced by XPREP ® could reduce the intestinal absorption of various active ingredients, altering their normal efficacy. Therefore, laxative intake should occur at least two hours after that of other drugs.

Potassium depletion, which could occur following prolonged laxative use, may enhance the functionality of some drugs, including digitalis.

Contraindications XPREP ® Concentrated Senna extract

XPREP ® should not be taken by children under the age of 10, by patients suffering from gastro-intestinal diseases, whether acute or chronic, obstruction or intestinal stenosis, or dehydration and alteration of electrolyte balance.

Undesirable effects - Side effects

The most commonly described side effects, following the use of XPREP ® include abdominal colic and cramps, which are much more intense and frequent in patients suffering from chronic constipation.

Prolonged use of laxatives could instead lead to a gradual reduction in the efficacy of the drug, accompanied by intestinal atony and constipation, possibly preceded by diarrhea, dehydration and hypokalemia.