Gidecek 10mg granules sachet No. 16

Gidecek 10mg granules sachet No. 16

Product Code: 8126
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Composition

active substance:racecadotril;

1 sachet contains 10 mg racecadotril or 30 mg racecadotril;

other ingredients:sucrose, silica colloidal anhydrous, polyacrylate dispersion, flavor of apricot.

The

Dosage form

Granules for oral suspension.

basic physico-chemical properties:white powder with a characteristic aroma of apricot.

The

drug description

other Antidiarrhoeal drugs.

A07X ATC Code A04.

The

Pharmacological properties

Pharmacodynamics.

Racecadotril is a prodrug that requires hydrolysis to form the active metabolite of Tirano, which is an inhibitor of enkephalinase, peptidase cell membranes, which is located in different tissues, especially in the epithelium of the small intestine. This enzyme contributes both to hydrolysis of exogenous and endogenous cleavage peptides, such as enkephalins. So, racecadotril protects enkephalins endogenous, physiologically active at the level of the digestive tract, prolonging their secretory function.

Racecadotril is an anti - secretory active ingredient exclusively in the intestinal mucosa. It decreases the intestinal hypersecretion of water and electrolytes caused by cholera toxins or inflammation and does not impact on basal secretory activity. Racecadotril shows rapid Antidiarrhoeal action without modifying the duration of intestinal transit.

Racecadotril does not cause bloating. In clinical studies, the incidence of secondary constipation on the background of the application racecadotril was similar observed in the placebo group.

When administered orally, the drug has solely a peripheral activity, without affecting the Central nervous system.

In two clinical studies of racecadotril in children has reduced the weight of the chair within the first 48 hours by 40% and 46%, respectively. There has also been a significant reduction in the duration of diarrhoea and the need to restore water balance.

within a meta-analysis of individual patients data (9 RCTs racecadotril placebo in addition to oral rehydration solution) has collected individual patient data (1384 boys and girls) suffering from acute diarrhoea of varying severity and were on inpatient or outpatient treatment . The average age was 12 months (inter - apartment width-from 6 to 39 months). Of the total number of patients 714 were under 1 year of age, 670 patients - under 1 year of age. The average body weight fluctuated during studies from 7.4 kg to 12.2 kg.the total average duration of diarrhoea after inclusion was 2.81 days in the placebo group and 1.75 days in the racecadotril group. The percentage of patients recovered was higher in the ratsekadotrilu groups than placebo [Hazard Ratio (HR): 2.04; 95% CI: 1.85 to 2.32; p <0.001; Cox Proportional Hazards region]. The results were very similar for infants ( 1 year) (HR: 2.16 ; 95% CI: 1.83 to 2.57; p <0.001). For inpatient patients (n = 637), the ratio of the mean weight of the chair in the group of taking ratsekadotril to the mean weight of the chair in the group of taking placebo was 0.59 (95% CI: 0.51 to 0.74) p <0.001). For outpatient patients (n = 695), the ratio of the average number of defecations in diarrhea in the ratsekadotrilu group to the average number of chairs in diarrhea in the placebo group was 0.63 (95% CI: from 0.47 to 0.85); p <0.001).

Pharmacokinetics.

suction

Racecadotril is rapidly absorbed after oral administration. The initial time to suppress plasma enkephalinase 30 minutes.

the Bioavailability racecadotril does not change as a result of meals, but maximum activity was delayed by about an hour and a half.

distribution

after taking the dose of labeled 14C ratsekadotril measured concentration of radioactive isotope of carbon in the blood plasma was many orders of magnitude higher than in blood cells, and three times higher than in the entire blood volume. Thus, the drug is largely not associated with blood cells. The distribution of the radioactive isotope of carbon in other tissues of the body is moderate, which proves the average apparent volume of distribution in plasma-66,4 kg.

Ninety percent of the active metabolite racecadotril, tiorfan (= (RS) -N- (1-oxo-2- (mercaptomethyl) -3-phenylpropyl) glycine), is associated with blood plasma proteins, mainly to albumin. Pharmacokinetic properties of racecadotril do not change when re-admission or when used in elderly patients.

the Duration and degree of exposure to racecadotril depend on the dose.

in children, the time to peak plasma suppression enkephalinase equal to approximately 2 hours and corresponds to suppression of 90% at the dose of 1.5 mg/kg. in adults, the time to peak plasma suppression enkephalinase equal to approximately 2 hours and corresponds to suppression of 75% at the dose of 100 mg.

the Duration of suppression of plasma enkephalinase is about 8:00.

metabolism

Biological half-life racecadotril, based on the degree of oppression plasma enkephalinase approximately 3 hours.

Racecadotril is rapidly hydrolyzed to tiorfan, an active metabolite which in turn turns into inactive metabolites.

reapply racecadotril does not lead to accumulation of compounds in the body.

datain vitroindicate that racecadotril/thiorphan and 4 major inactive metabolites inhibit major CYP enzyme isoforms of ZA4, 2D6, 2C9, 1A2 and 2C19 clinically significant degrees.

datain vitroindicate that racecadotril/thiorphan and 4 major inactive metabolites do not stimulate CYP enzyme isoforms (class PO, 2A6, 2B6, 2C9/2C19, class 1A, 2E1) and UGO conjugation enzymes of clinically significant degree.

Racecadotril does not affect protein binding of active substances, largely associated with proteins such as tolbutamide, warfarin, niflumic acid, digoxin or phenytoin.

in patients with impaired hepatic function [cirrhosis, degree B according to child-Pugh classification], the kinetics profile of the active metabolite racecadotril was observed Tmaxand t?, similar to those observed in healthy volunteers, but smaller Cmax(-65%) and AUC ( -29%).

in patients with severe renal impairment (CRCL 11 to 39 ml/min), the profile of the kinetics of the active metabolite racecadotril noted below, Cmax(-49%) and a higher AUC (+ 16%) and T?than in healthy volunteers (creatinine clearance> 70 ml/min).

in children, pharmacokinetic parameters are similar in adults, reaching Cmax2:00 30 minutes after administration. There is no accumulation after repeated receptions every 8:00 for 7 days.

output

Racecadotril is derived in the form of both active and inactive metabolites. Report mostly kidneys, to a much lesser extent in the feces. Pulmonary withdrawal is insignificant.

Reading

Auxiliary symptomatic treatment of acute diarrhoea in infants (aged 3 months) and children in combination with oral rehydration and the usual support measures, when these measures are insufficient to control the clinical condition and when causal treatment is not possible.

In case of possibility of etiotropic treatment of racecadotril can be used as adjuvant therapy.

Contra

hypersensitivity to the active substance or to any of the excipients.

due to the presence of sucrose Gidecek contraindicated for use in patients with rare hereditary fructose intolerance, malabsorption syndrome of glucose-galactose or saharas-isomaltase failure.

The

Interaction with other medicinal products and other forms of interaction

Interaction with other preparations at the person isn't recorded today.

the Simultaneous use of racecadotril with loperamide or Nifuroxazide in human does not change the kinetics racecadotril.

application Features

the use of the drug of Hydratec does not change the General mode of rehydration.

Restoring water balance is extremely important in the treatment of acute diarrhoea in children. To restore the water balance and the way to achieve it, it is necessary to take into account the patient's age and body weight, as well as the condition and severity, especially in the case of serious or prolonged diarrhea, accompanied by significant vomiting or loss of appetite. It is also important not to interrupt regular meals (including breastfeeding) and to monitor the intake of sufficient fluid.

Bloody or purulent stool and fever may indicate or the presence of invasive bacteria as a cause of diarrhea, or other severe disease requiring specific treatment (e.g. antibiotics) or further study. Therefore, racecadotril should not be used in such cases. Racecadotril can be used together with antibiotics in the case of acute diarrhea of bacterial etiology as an additional therapy.

Application racecadotril in case of diarrhea caused by antibiotic treatment, and chronic diarrhea is not recommended due to insufficient amount of data.

diabetes Patients should be aware that each sachet contains

Hydratec 10 mg 0,966 g of sucrose;

Hydratec 30 mg 2,899 g of sucrose.

If the amount of sucrose (sources of glucose and fructose) in the daily dose of Hydrates exceeds 5 g per day, it must be taken into account in the daily diet of sugar.

you should Not apply the medication in a newborn under 3 months because clinical research in this population has not been conducted.

Drug should not be used in children with impaired renal function or liver disease of any severity due to the limited information about this population.

due to the possibility of reducing bioavailability, the drug should not be used in case of prolonged or uncontrolled vomiting.

use during pregnancy or lactation.

Pregnancy.

there are No adequate data on the use racecadotril pregnant women. Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryofetal development, during birth or postnatal development. However, since no special clinical studies have been conducted, racecadotril should not be used during pregnancy.

breastfeeding.

because of the lack of information on the allocation of Hydratec of the drug in breast milk should not be used during breast-feeding.

Ability to influence the reaction rate when driving motor transport or operating other mechanisms.

Racecadotril does not affect or has little effect on the ability to drive and use machines.

Method of application and doses

Hydratec administered orally together with oral rehydration (see Section "Peculiarities of use").

Hydratec 10 mg is used in children with body weight under 13 kg.

the Recommended dose is calculated by body weight: 1.5 mg/kg per reception. This is 1-2 sachets of appropriate dosing, which is taken 3 times a day at regular intervals.

Children with body weight up to 9 kg: 1 sachet (10 mg) 3 times a day.

children weighing between 9 kg and 13 kg: 2 sachets (10 mg) 3 times a day.

Children with a body mass of from 13 kg to 27 kg: 1 sachet (30 mg) 3 times a day.

Children weighing more than 27 kg: 2 sachets (30 mg) 3 times a day.

in clinical trials involving children, the duration of treatment was 5 days.

Treatment should be continued until 2 cases of the normal nature of the chair have been reported.

the duration of treatment should not exceed 7 days.

long-term treatment with racecadotril is not recommended.

Clinical trials involving children under 3 months of age were not conducted.

Special patient groups

a Study involving infants or children with renal or hepatic insufficiency have not been conducted (see Section "Peculiarities of use").

the drug should be used with caution in patients with renal or hepatic insufficiency.

Granules drug Gidecek you can add to food, dissolving them in a glass of water or bottle for feeding, mix well. After that, the drug should be used immediately.

Children.

Hydrants, granules of 10 mg, used in infants and children aged 3 months to 2 years.

Hydratec, granules 30 mg, administered to children 2 years of age.

Overdose

no overdose Cases have been reported.

in adults, single doses of more than 2 g, that is 20 times higher than the therapeutic dose, did not cause harmful effects.

The

Adverse reactions.

below are adverse reactions to the drug, noted in the group ratsekadotrilu more often than in the placebo group, or recorded in the post-registration period. The frequency of adverse reactions were divided into: very often (? 1/10), often (? 1/100 to <1/10), infrequent (? 1/1 000 to <1/100), rare (? 1/10000 to <1/1000), very rare (<1/10000), unknown frequency (cannot be determined from the available data).

Infections and infestations

Uncommon: tonsillitis.

on the part of the skin and subcutaneous tissue

Uncommon: rash, erythema.

Unknown frequency: polymorphic erythema, tongue edema, facial edema, lip edema, eyelid edema, angioedema, urticaria, nodular erythema, rash, prurigo, itching.

The

shelf Life

2 years old.

storage Conditions

Store at a temperature not exceeding 25 ° C out of reach of children.

The

Packaging

For 16 sachets in a cardboard box.

The

Category vacation

over the counter.

The

Manufacturer

Startex/Sophartex.

location of the manufacturer and address of the place of business

28500, Vernier, Rue du Pressoir, 21 France/28500, Vernouillet, 21 rue du Pressoir, France.

The

The Applicant

Abbott Laboratories GmbH/Abbott Laboratories GmbH.

location of the applicant

Freundallee 9A, 30173 Hannover, Germany/Freundallee 9A, 30173 Hannover, Germany.

GRANULES of HYDRATEC 10MG

Hydratec 10 mg granules sachet No. 16 – effective Pro-drug. The tool is an active inhibitor of enkephalinase, cellular peptidase located in various tissues, especially in the large intestine. The active substance is racecadotril, prolongs the anti-secretory function of endogenous encephalins. The drug reduces the secretion of water, electrolytes, caused by toxic cholera cells, inflammatory processes, has an Antidiarrhoeal effect. Shown to eliminate the symptoms of acute diarrhea in infants from three months and adults.

the dosing regimen and contraindications

the oral Medicament is used in combination with other drugs. The optimal dosage is calculated based on the patient's total body weight. The recommended norm is 1.5 mg/kg, which corresponds to two sachets. Contraindications:

    The
  • fructose Intolerance.
  • The
  • Syndrome of malabsorbtion of hycosy.
  • renal and hepatic disorders.
  • The
  • Saharazo-isomaltase failure.

the pharmaceutical Product is not used in the presence of indomitable vomiting. Granules do not change the standard mode of restoration of water balance. This causes mandatory consumption of sufficient amount of liquid.

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