Symptoms : Currently, isolated cases of overdose without side effects are known. In adults, taking a single dose of the drug more than 2 g, equivalent to a 20-fold therapeutic dose, did not cause adverse effects.
hypersensitivity to the active substance or any other component of the drug ;
congenital malpability of galactose, lack of lactase, glucose-galactose malabsorption syndrome (due to the fact that the drug contains lactose);
pregnancy;
period of breastfeeding ;
childhood up to 18 years (due to the high content of the active substance).
Currently, data on interaction with other drugs are not available.
Solid gelatin capsules No. 1 with a yellow case and a lid.
Capesil contents : powder is white or almost white.
Messages about the following unwanted reactions were noted when taking a racecadotrile more often than when taking placebo, or were received during post-marketing use.
From the side of the nervous system : often (≥1/100, <1/10) - headache.
From the skin and subcutaneous tissue : infrequently (≥1/1000, <1/100) - skin rash, erythema; frequency is unknown (for assessing the frequency of cases of available data is not enough) - polymorphic erythema, language edema, swelling of the face, swelling of the lips, swelling of the eyed, dye, stained glass,.
According to the recipe.
The use of the drug Diasek® does not exclude oral rehydration in cases where it is necessary.
The presence of blood-stained or purulent secretions in the stool and high temperatures can serve as symptoms of invasive bacterial infection that caused diarrhea or other serious illness, which is the basis for etiotropic therapy (for example, using antibiotics) or further research. Monotherapy with racecadotril in these conditions is contraindicated. As an additional therapy for acute bacterial diarrhea, racecadotril can be used in conjunction with antibiotics.
Due to insufficient data, it is not recommended to use cancer cadotril in antibiotic-sociated diarrhea and chronic diarrhea.
Due to insufficient data, racecadotrile should be used with caution to patients with renal and liver failure.
The bioavailability of racecadotril can be reduced by multiple vomiting.
Impact on the ability to drive a car and other mechanisms. The use of the drug Diasek® does not affect or have a slight effect on the ability to drive a car and mechanisms.
Symptomatic treatment of acute diarrhea in adults.
Racecadotril is a prolific value that is hydrolyzed to active metabolite - thiorphan, which is an inhibitor of encephalinase - surface peptidase (located on cell membrane), localized in various tissues, especially in the epithelium of the small intestine. This enzyme is responsible for simultaneously hydrolysis of exogenous peptides and splitting of endogenous peptides such as enkefalins. As a result, racecadotril protects endogenous epkefalins, which exhibit physiological activity at the level of the digestive tract, prolonging their anti-secretory effect.
Racekadotril is an intestinal anti-secretory substance. It reduces intestinal hypersecretion of water and electrolytes caused by cholera enterotoxin or inflammation, and does not affect the basal secretion of the intestines.
Racecadotril has a quick anti-wire effect without changing the travel time of intestinal contents through the intestines.
Racekadotril does not cause bloating.
In clinical studies, the frequency of secondary constipation when taking racecadotrile was comparable to placebo.
Suction. After taking inside, the racecadotril is quickly absorbed. The time before the start of inhibition of plasma encephalinase is 30 minutes. Eating does not affect the bioavailability of cancer, but after eating, the activity of the drug is delayed by about an hour and a half.
Distribution. In a blood plasma after the use of a racecadotrile labeled with a radioactive isotope 14C, the content of radiocarbon was many times higher than in blood cells, and 3 times higher than in whole blood. Thus, the drug is slightly associated with blood cells. Radio carbon is moderately distributed in other tissues of the body, as evidenced by its apparent Vd in plasma - 66.4 kg.
90% of the active metabolite of racecadotril (tiorphan) ((RS) -N (1-oxo-2- (merkaptomethyl) -3-phenylpropyl) glycine) is associated with plasma proteins, mainly with albumin.
The pharmaceutical properties of racecadotrile do not change as a result of taking repeated doses, as well as when appointing elderly patients.
When taking a racecadotrile at a dose of 100 mg, the peak inhibition time of plasma enkephalinase is approximately 2 hours and corresponds to 75% inhibition. The duration and effectiveness of the cancer is dependent on the dose of the drug. In adults, the time before peak inhibition of plasma ekephalinase is approximately 2 hours and corresponds to 75% inhibition when taking a dose of 100 mg. The plasma encibling time is approximately 8 hours.
Metabolism. Biological T1/2 the racecadotril, measured as the inhibition time of plasma enkephalinase, is approximately 3 hours.
Racecadotril quickly hydrolyzes to thyorphan, an active metabolite, which, in turn, is transformed into inactive metabolites. Taking repeated doses of racecadotrile does not lead to its accumulation in the body. Data obtained from studies in vitroshow that racecadotril / thyorphan and 4 major inactive metabolites do not inhibit CYP isopheniums (3A4, 2D6, 2C9, 1F2, and 2C19) to a degree that can be clinically significant.
Data obtained from studies in vitro, show that racecadotril / thyorphan and 4 main inactive metabolites do not induce isopheniums of CYP (3A, 2A6, 2B6, 2C9 / 2C19, 1A, 2E1) and UDF-GT to the extent that can be clinically significant.
Racecadotril does not affect protein binding of active substances such as colbutamide, warfarin, niflumic acid, digoxin or phenytoin.
In patients with liver failure (class B according to the Child-Pew classification), the kinetic profile of active racecadotril metabolite showed similar indicators Tmax and T1/2 and lower rates Cmax in blood (−65%) and AUC (−29%) compared to these indicators in healthy people.
In patients with severe renal failure (Cl creatinine 11–39 ml / min), the kinetic profile of active racecadotril metabolite showed a lower Cmax (−49%) and higher rates of AUC (+ 16%) and T1/2 compared to healthy volunteers (Cl creatinine> 70 ml / min). Cmax achieved after 2 h 30 minutes after application.
There was no cumulation when taking the drug again every 8 hours for 7 days.
The conclusion. Racekadotril is excreted from the body in the form of active and inactive metabolites, mainly through the kidneys, and to a much lesser extent with kalom. The output through the lungs is insignificant.
Keep out of the reach of children.
Shelf life of the drug Diasek®3 years.Do not apply after the expiration date indicated on the package.
| Capsules | 1 caps. |
| active substance : | |
| racecadotril | 100 mg |
| auxiliary substances : starch corn; lactose monogydrate; silicon dioxide colloidal (aerosil); talcum powder | |
| hard gelatin capsules (body and lid) : titanium dioxide; dye ginolin yellow; dye "Sunny sunset" yellow; gelatin |
Capsules, 100 mg. For 9, 10, 18 or 20 caps. in contour cell packaging made of PVC film and aluminum printed lacquered foil.
For 1, 2, 3, 4, 5 contour cell packages are placed in a pack of cardboard.
Sufficient data on the use of racecadotrile in pregnant women are not available. In animal studies, there are no direct or indirect adverse effects regarding pregnancy, embryonic development, childbirth, and postpartum development. However, due to the lack of clinical data, the drug Diasek should not be used® during pregnancy.
Due to the lack of information on the excretion of breast-milk cancer, the drug Diasek should not be used® during breastfeeding.
Inside. The first capsule at the beginning of treatment is taken regardless of the time of day. Next - 1 caps. 3 times a day before eating. Treatment must be continued until the stool is normalized (the normal feces appears up to 2 times), but no more than 7 days. It is not recommended to use racecadotrile for a long time.
Special patient groups
Elderly age. A dose correction for elderly patients is not required.
