Supplementary symptomatic treatment of acute diarrhea in infants (> 3 months old) and in children, with the simultaneous use of oral hydration and usual maintenance, if such treatment alone does not allow to control clinical symptoms, and causal treatment is not possible. If causative treatment can be used, racecadotril can be given as adjuvant therapy.
Composition:
1 sachet contains 10 mg or 30 mg of racecadotryl; the drug contains sucrose.
Action:
Anti-diarrheal drug. Racecadotril is a prodrug that is hydrolyzed to the active metabolite thiorphan. Tiorfan is an inhibitor of intestinal enkephalinase - a protein enzyme involved in the digestion of exogenous proteins as well as the breakdown of endogenous proteins such as enkephalins. Racecadotril prevents the enzymatic breakdown of enkephalins and thus prolongs their action in enucleeplegic synapses in the small intestine and reduces hypersecretion. Racecadotril is an active substance with antisecretory activity only in the intestines. Reduces cholera toxins caused by inflammation or inflammation, excessive secretion of water and electrolytes through the intestine and does not affect the basic secretory activity. It triggers a quick anti-diarrheal action without changing the continuity of passage through the intestines. Following oral administration, racecadotril is rapidly absorbed and hydrolysed to the active metabolite - thiorphan, which in turn is further converted into inactive metabolites. The greatest inhibition of enkephalinase in plasma is achieved after about 2 hours and corresponds to 90% inhibition after a dose of 1.5 mg / kg. The duration of the inhibition of enkephalinase is about 8 h. T0,5, measured as inhibition of enkephalinase in the plasma, is about 3 h. Racecadotril is removed in the form of inactive metabolites, mainly via the kidneys (81.4%) and to a much lesser extent in the faeces (8%); Lung excretion is slight (<1% of the dose).
Contraindications:
Hypersensitivity to the active substance or any of the excipients. Due to the sucrose content, do not use in patients with rare inherited disorders associated with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.
Precautions:
Do not use in children <3 months, in children with impaired renal or liver function, or to treat diarrhea associated with the use of antibiotics (no studies). Due to the likelihood of reduced bioavailability, do not administer prolonged, uncontrolled vomiting. The drug has not been sufficiently tested during chronic diarrhea. The occurrence of blood or purulent stools accompanied by a fever may indicate a bacterial infection that is the cause of diarrhea or the presence of other serious diseases. Taking the medicine does not change the standard method of watering. In case of severe or prolonged diarrhea with accompanying vomiting or lack of appetite, intravenous irrigation should be considered. Sucrose content (0.966 g / mixed 10 mg and 2.899 g / mixed 30 mg) should be considered when used in patients with diabetes. If the amount of sucrose present in the daily dose of the drug exceeds 5 g / day, it should be included in the daily portion of sugar.
Pregnancy and lactation:
Animal studies do not indicate any harmful effects of racecadotril on pregnancy, fetal and / or neonatal health, parturition and postnatal development. However, because specific clinical trials are not available, racecadotril should not be used during pregnancy. Due to the lack of data on the excretion of racecadotril in human milk, racecadotril should not be used during breastfeeding.
Oral: 1.5 mg / kg 3 times a day, at regular intervals. In infants and children about the month of <13 kg sachets 10 mg are used, in children of the month. ≥13 kg - 30 mg sachets. Children about the month of <9 kg: 10 mg 3 times a day; mc.from 9 to 13 kg: 20 mg 3 times a day; mc. from 13 to 27 kg: 30 mg 3 times a day; mc. > 27 kg: 60 mg 3 times a day. Simultaneously with the preparation, oral irrigation fluids should be administered. Treatment should be continued until two normal stools are given; should not last longer than 7 days; long-term treatment with racecadotril is not recommended. Pellets can be added to food, glasses of water or feeding bottles, mixed well and immediately administered.
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