Hidrasec caps 100mg #10

Instruction for Hidrasec

You can buy Hidrasec here

Hidrasec is a drug used for the symptomatic treatment of diarrhea.

Release form and composition

Dosage form - capsules: hard gelatin, light yellow, size No. 2, the capsules contain a white powder with a characteristic odor (in a cardboard pack of 1 or 2 blisters of 10 capsules and instructions for use of Hidrasec).
Composition 1 capsule:
    active substance: racecadotril - 100 mg;
    auxiliary components: magnesium stearate - 4 mg; lactose monohydrate - 41 mg; pregelatinized corn starch - 78 mg; colloidal silicon dioxide - 2 mg;
    capsule shell: titanium dioxide (E171) - 2%; yellow dye iron oxide (E172) - 0.1%; gelatin - up to 100%.

Pharmacodynamics

Racecadotril - the active substance of Hidrasec is a prodrug that hydrolyzes with the formation of tiorphan. This is an active metabolite, which is an inhibitor of enkephalinase, a surface peptidase (which is located on the cell membrane), localized in various tissues, especially in the epithelial tissues of the small intestine. Enkephalinase enzyme is necessary for the hydrolysis of exogenous peptides and the breakdown of endogenous peptides, such as enkephalins. Thus, racecadotril protects endogenous enkephalins that exhibit physiological activity at the level of the digestive tract and prolongs their antisecretory effect.
Being an intestinal antisecretory substance, racecadotril acts targeted to reduce intestinal hypersecretion of water and electrolytes caused by cholera inflammation or enterotoxin. The substance does not affect the basal secretion of the intestine.
When conducting clinical studies, it was found that the incidence of secondary constipation when taking racecadotril does not differ from that when using placebo.
Racecadotril, having a rapid antidiarrheal effect, does not affect the passage of intestinal contents through the intestine and does not lead to bloating.

Pharmacokinetics

Racecadotril after oral administration is absorbed rapidly. The time required to start inhibition of plasma enkephalinase is 30 minutes.
Eating does not affect the bioavailability of the substance, but if the drug is used after eating, its activity appears with a delay of about 90 minutes.
After taking racecadotril labeled with the radioactive isotope 14C, the plasma content of the substance is many times higher than its content in blood cells and 3 times higher than in whole blood. Thus, the drug binds slightly to blood cells. In other body tissues, radiocarbon is moderately distributed, as evidenced by the apparent Vd (distribution volume) in plasma. Up to 90% of tiorphan binds to plasma proteins, mainly with albumin.
The pharmacokinetic properties of the substance as a result of taking repeated doses, as well as when used by elderly patients, do not change.
The effectiveness and duration of the action depends on the dose. The time to peak inhibition of plasma enkephalinase in adult patients is approximately 2 hours. The total plasma enkephalinase inhibition time is about 8 hours.
Biological T1 / 2 (half-life) of racecadotril (corresponds to the time of plasma enkephalinase inhibition) is approximately 3 hours.
Racecadotril is rapidly hydrolyzed to tiorphan; later, tiorphan is transformed into inactive metabolites. With repeated use of the drug, its accumulation in the body does not occur. Racecadotril / tiorphan and the four main inactive metabolites of the CYP enzyme isoform (3A4, 2D6, 2C9, 1A2 and 2C19) are reported to be not clinically significant inhibition. Also, to a clinically significant degree, they do not induce conjugated enzymes UGTs (uridininglucuronosyl transferase) and cytochrome CYP isoforms (3A, 2A6, 2B6, 2C9 / 2C19, 1A, 2E1).
Racecadotril does not affect the protein binding of the following active substances: warfarin, tolbutamide, niflumic acid, phenytoin, digoxin.
The kinetic profile of the active metabolite of racecadotril in liver failure (according to the Child-Pugh classification B class), in comparison with the values ​​of these indicators in healthy people, shows similar T1 / 2 and Tmax (time to reach maximum concentration) in blood and lower Cmax (maximum concentration of the substance) in the blood and AUC (the area under the curve "concentration - time") (65 and 29%, respectively).
The kinetic profile of the active metabolite of racecadotril in severe renal failure (in patients with creatinine clearance of 11–39 ml / min), in comparison with healthy volunteers, shows a lower Cmax and higher AUC and T1 / 2.
Cmax after taking the drug is achieved after 2 hours 30 minutes.
With repeated use of Hidrasec every 8 hours for 7 days, cumulation is not observed.
The elimination of racecadotril from the body is carried out in the form of metabolites (active and inactive) mainly through the kidneys, with feces - to a much lesser extent. A small portion of the dose is excreted through the lungs.

Indications for use

Hidrasec is prescribed for the symptomatic treatment of acute diarrhea.

Contraindications

Absolute:
    lactase deficiency, congenital galactose intolerance, glucose-galactose malabsorption syndrome;
    pregnancy and lactation;
    age up to 18 years;
    individual intolerance to the components of the drug.
Relative (use of Hidrasec requires caution): renal failure and / or liver failure.

Hidrasec, instructions for use: method and dosage

Hidrasec capsules are taken orally.
The first capsule can be taken regardless of the time of day. In the future, the drug is taken three times a day before meals, 1 capsule.
Therapy is carried out until the stool normalizes (the appearance of at least two times normal stool), but not longer than 7 days. Long-term use of Hidrasec is not recommended.

Side effects

During therapy, the development of the following adverse events is possible [> 10% - very often; (> 1% and <10%) - often; (> 0.1% and <1%) - infrequently; (> 0.01% and <0.1%) - rarely; <0.01% - very rare]:
    skin and subcutaneous tissue: infrequently - erythema, skin rash; with an unknown frequency - toxic dermatitis, polymorphic erythema, swelling of the eyelids, face, tongue, lips, urticaria, angioedema, papular rash, erythema nodosum, pruritus, prurigo;
    nervous system: often a headache.

Overdose

Currently, isolated cases of an overdose of racecadotril without the development of adverse events have been reported.
A single dose of a dose corresponding to a 20-fold therapeutic dose did not lead to side effects.

Special instructions

Hidrasec therapy from oral rehydration in cases where it is necessary does not relieve.
Symptoms of an invasive bacterial infection or other serious illness that causes diarrhea can manifest as purulent / bloody discharge in the stool and high fever. This is the basis for etiotropic treatment (including including antibiotics) or further research. In these conditions, the use of racecadotril in the form of monotherapy is contraindicated. Hidrasec can be used in combination with antibiotics as an additional drug.
Hidrasec capsules are not recommended for the treatment of chronic and antibiotic-associated diarrhea.
With repeated vomiting, the bioavailability of racecadotril may decrease.

Pregnancy and lactation

Hidrasec during pregnancy / lactation is not prescribed.
There is no information on the use of racecadotril in pregnant women to determine the safety and effectiveness of the drug during these periods of a woman's life. When conducting animal studies, racecadotril did not have a direct / indirect adverse effect in relation to the course of pregnancy, embryonic development, childbirth or postpartum development.

Use in childhood

For patients under the age of 18, Hidrasec is not prescribed.

With impaired renal function

The use of Hidrasec in renal failure requires caution.

With impaired liver function

The use of Hidrasec in liver failure requires caution.

Drug interaction

There is no information on the interaction of Hidrasec with other substances / drugs.
Loperamide or nifuroxazide, used simultaneously with racecadotril, does not affect the kinetics of the latter.

Terms and conditions of storage

Store at temperatures up to 25 ° C. Keep out of the reach of children.
Shelf life is 3 years.

Reviews

In a few reviews of Hidrasec, patients note that the drug has a rapid antidiarrheal effect.

Terms of sell

You can buy Hidrasec without a prescription.