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Gidrasek 16’s 10 mg granules for oral suspension




The trade name
Gidrasek ®

the International unlicensed

name Ratsekadotril Lekarstvennaya
the Granule form for preparation of suspension for intake, 10 mg and 30 mg

of One sachet – a bag contains
active agent – ratsekadotrit 10 mg or 30 mg,
excipients: sucrose, silicon dioxide colloidal anhydrous, polyacrylate dispersion of 30% (Eudrazhit® of NE 30 D), apricot fragrance (No. 6 Polvaromas-IFF).

The description
Powder of white color with a characteristic apricot smell.

Pharmacotherapeutic group
Antidiarrheal drugs. Other anti-diarrheal drugs. Ratsekadotril.
ATX A07XA04 code


Pharmacokinetics Absorption properties. At intake ratsekadotrit quickly it is soaked up. Its pharmacological action on inhibition of an enkefalinaza of plasma begins in 30 minutes. The bioavailability of a ratsekadotril does not change at meal, but the peak activity comes later approximately on an hour and a half.
Distribution. Only about 1% of the accepted dose is found in body tissues. About 90% of an active metabolite of a ratsekadotril – (RS) – N-okco-2-(mercaptomethyl) – 3-fenilpropit) glycine, contacts plasma proteins, mainly, with albumine. Pharmacokinetic properties of a ratsekadotril do not change at reception of repeated doses at adults.
Duration and expressiveness of action of a ratsekadotril are dose-dependent. Time of achievement of the maximum activity on inhibition of an enkefalinaza of plasma is about 2 hours and there correspond 75% to suppression of activity in a dose of 100 mg.
At a dose of 100 mg the inhibition of an enkefalinaza of plasma lasts about 8 hours.
Metabolism. Time biological semi-removal, measured by plasma enkefalinaza inhibition duration, about 3 hours.
Ratseakdotril is quickly hydrolyzed in (RS) – N-okco-2-(mercaptomethyl) – 3-fenilpropit) glycine, an active metabolite which, in turn, is transformed to inactive metabolites. Repeated reception of a ratsekadotril does not cause cumulation in an organism. Ratsekadotril does not possess either overwhelming, nor promoting effect on the system of P450 cytochrome.
Ratsekadotril does not influence extent of linking with proteins of plasma of active agents which to a large extent contact proteins of plasma, such as tolbutamide, warfarin, niflumovy acid, digoxin and Phenytoinum.
Removal. Ratsekadotril is brought mainly in the form of inactive metabolites with urine and also in small amounts with excrements. Removal through lungs is insignificant.
At patients with a liver failure (cirrhosis, class B on Chayld-Pyyu) the following features of a pharmacokinetic profile of an active metabolite of a ratsekadotril in comparison with healthy faces were revealed: similar values of time of achievement of the maximum concentration (Tmax) and elimination half-life (T1/2), and value of the maximum concentration (Cmax) and the area under curve (AUC) – lower (-65% and – 29%, respectively).
At patients with a heavy renal failure (clearance of creatinine (CC) of 11-39 ml/min.) the kinetic profile of an active metabolite of a ratsekadotril showed lower maximum concentration (Cmax) (-49%) and higher values of the area under curve (AUC) (+16%) and elimination half-life (T1/2), in comparison with healthy faces which KK have more than 70 ml/min.
The pharmacodynamics
Ratsekadotril is inactive substance, as a result of hydrolysis he turns in tiorfan which has property to inhibit an enkefalinaza, the peptidase of a cellular membrane localized in various fabrics, especially in epithelial cells of a small intestine. This enzyme participates in hydrolysis of exogenous peptides and splitting of endogenous peptides, such as enkephalins. Therefore, ratsekadotrit protects endogenous enkephalins which are physiologically active at the level of a digestive tract, prolonging their anti-secretory action.
Ratsekadotril represents substance with anti-secretory action, its activity is limited mucous a small intestine. It reduces the hypersecretion of water and electrolytes in a small intestine caused by cholera toxin or inflammation does not affect basal secretory activity. Ratsekadotril quickly shows antidiarrheal action, without influence on duration of intestinal transit.
Ratsekadotril does not cause an abdominal distension. In clinical trials the frequency of a secondary constipation at reception of a ratsekadotril is comparable with the group accepting placebo.
At intake its activity is shown only at the peripheral level, without impact on the central nervous system.

– as an additional tool for symptomatic therapy of acute diarrhea at children and babies (3 months are more senior) when oral rehydration and the standard supporting measures are not sufficient for control of a clinical state

the Route of administration and doses
of Gidrasek® accept inside, in a combination with rehydration therapy.
Doses define according to body weight: at the rate of 1.5 mg/kg on each reception. After an initial dose accept 3 times a day. Treatment is continued before achievement of a 2-fold normal chair in day. The course of treatment – usually 5 days, but should not exceed 7 days.
The granule can be added to food or to stir in glass with water or in a small bottle with food. It is good to stir and give to the child immediately.
Special groups of patients
clinical trials with participation of babies were not conducted 3 months are younger.
Children and babies with a renal and liver failure did not take part in clinical trials.

Side effects
Exist data of the clinical trials (CT) with participation of 685 patients of children’s age who had diarrhea and accepting ratsekadotrit, in comparison with data of KI with participation of 411 patients of children’s age accepting placebo and 50 patients accepting loperamide. The general frequency of by-effects was 15% in group of receiving ratsekadotrit, 23.1% in group of placebo and 22% in group of loperamide. Were most often noted vomiting (7.9% in comparison with 9.2% in group of placebo and 12% in group of loperamide), fervescence (3.2% in comparison with 7.3% in group of placebo and 4% in group of loperamide) and by-effects from a respiratory system (1% against 1.5% in group of placebo and 0% in group of loperamide).
Side reactions which were observed at reception of a ratsekadotril more often than at intake of placebo are listed below, or recorded in post-marketing practice.
Often (& gt, 1/100, & lt, 1/10)
– a headache
Infrequently (& gt, 1/1000, & lt, 1/100)
– rash, an erythema
– tonsillitis
Frequency is unknown
– a multiformny erythema, a paraglossa, a face edema, hypostasis of lips, the century, a Quincke’s disease, urticaria, a knotty erythema, papular rash, a prurigo, an itching, a toxic epidermal necrolysis

of the Contraindication
– hypersensitivity to active or to any of drug excipients
– intolerance of fructose, a sprue of glucose or deficiency of invertase-isomaltase (drug contains sucrose)
– children’s age up to 3 months of life as data on safety and efficiency do not exist
– a renal and liver failure at children irrespective of degree of manifestation swelled, due to the lack of data on use for this group of patients

Medicinal interactions
there are no messages about medicinal interactions of a ratsekadotril at the person Today. It is known that the concomitant use with nifuroksazidy and loperamide does not change kinetics of a ratsekadotril.

Special instructions
At treatment by Gidrasek it is necessary to observe the rehydration mode. It is very important that the child drank enough liquid for maintenance of water balance.
In case of heavy and long diarrhea in combination with the profound vomiting or lack of appetite, it is necessary to consider the possibility of intravenous rehydration.
Presence at a chair of impurity of blood or pus and/or temperature increase can indicate bacterial intestinal infection as the cause of diarrhea, or presence of other serious disease. Therefore Gidrasek is not recommended to accept at such states.
Gidrasek’s influence on chronic diarrhea and on the antibiotiko-associated diarrhea is not studied.
At treatment of patients with diabetes it is necessary to take into account that each bag contains sucrose in the following quantities:
¿ñÓáßѬ® 10 mg: 0.966 g on one 1 g a bag
of Гидрасек® 30 mg: 2.899 g of sucrose on one 3 g a bag
If amount of sucrose (source of glucose and fructose) in the daily number of Gidrasek of 10 mg or 30 mg exceed 5 g, it should be considered when calculating daily consumption of sugars.
¿ñÓáßѬ® 10 mg and Гидрасек® 30 mg cannot be given to babies 3 months as data on safety and efficiency do not exist are younger. Drug also should not be given to children with a renal and liver failure irrespective of degree of manifestation, due to the lack of data on use in this group of the population.
In long vomiting the bioavailability of a ratsekadotril can be reduced.
Pregnancy and the period of a lactation
the granule Drug Gidrasek® for preparation of suspension is not intended for use for the women planning pregnancy and pregnant women. Preclinical trials did not show direct or indirect harmful effects of a ratsekadotril on a pregnancy course, development of an embryo and a fruit, a course of childbirth and a puerperal period. However in the absence of clinical data Gidrasek’s reception by pregnant women is not recommended.
Гидрасек® the women nursing as has not enough data on excretion of a ratsekadotril with breast milk the person should not accept.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Clinical trials with participation of adults showed that Gidrasek® does not influence (or influence insignificant) on ability to drive the car and to work on potentially dangerous equipment.

The overdose
does not exist messages about Gidrasek’s overdose. Adults have a single dose in a dose 2 g that is equivalent to 20 therapeutic doses, did not cause negative effect.
Symptoms: strengthening of side effect is possible.
Treatment: symptomatic.

The form of release and packing
On 1 g (for a dosage of 10 mg) or on 3 g (for a dosage of 30 mg) drug place in a sachet bags from a film polyvinylchloride / polyethylene / polyvinyldichloride (PVC/PE/PVDC).
On 16 (for a dosage of 10 mg) or on 20 (for a dosage of 30 mg) bags in a cardboard pack of the instruction for medical use in the state and Russian languages.

To Store storage conditions at a temperature not above 25 °C.
To store out of children’s reach!

3 years
not to apply a period of storage after an expiration date.

Prescription status
According to the prescription

of Proizvoditel Laboratories of Sofartex, France
to Develop

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