Product image of Hidrasec Pro Děti (Racecadotril) supplied by GNH India

Hidrasec Pro Děti

Active Ingredient:
Racecadotril
Origin:
EU

Hidrasec Pro Děti (Racecadotril)

Hidrasec Pro Děti is an oral pediatric formulation containing the active ingredient racecadotril. It is marketed in the European Union as an enkephalinase inhibitor used for the symptomatic treatment of acute diarrhea in children. The product is supplied without a specified strength in the available information, and it is intended for oral administration. It is classified under ATC code A07DA03 and belongs to the therapeutic class of antidiarrheal agents.

Manufacturer / TM Owner

Bioprojet Europe Ltd

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Indications & Clinical Uses

Hidrasec Pro Děti is indicated for the management of acute, non‑bloody diarrhea in children, helping to reduce stool frequency and volume while maintaining hydration.

  • Symptomatic relief of watery stools in infants and toddlers.
  • Support of oral rehydration therapy by decreasing intestinal fluid loss.
  • Use in cases of viral gastroenteritis where bacterial infection is not confirmed.
  • Adjunct treatment for travel‑related diarrhea in pediatric travelers.
  • Suitable for short‑term use during the acute phase of diarrheal illness.

How It Works

  • Racecadotril is a peripheral enkephalinase inhibitor. After oral absorption it is converted to its active metabolite thiorphan, which blocks the enzyme enkephalinase (neutral endopeptidase). This inhibition raises the level of endogenous enkephalins in the intestinal mucosa, leading to activation of opioid receptors on enteric neurons. The resulting effect reduces hypersecretion of chloride and water into the intestinal lumen without affecting intestinal motility, thereby decreasing stool output.

Side Effects

Like many antidiarrheal agents, racecadotril may be associated with adverse reactions, most of which are mild and transient.

Common

  • Mild abdominal discomfort or cramping.
  • Nausea or occasional vomiting.
  • Transient headache.
  • Slight increase in serum creatinine in rare cases.
  • Skin rash or mild pruritus.

Serious

  • Allergic reactions such as urticaria, angioedema, or anaphylaxis.
  • Severe abdominal pain indicative of intestinal obstruction.
  • Persistent vomiting leading to dehydration.
  • Hepatic dysfunction manifested by elevated transaminases.
  • Nephrotoxicity in patients with pre‑existing kidney disease.

Precautions & Warnings

When prescribing Hidrasec Pro Děti, clinicians should consider several precautionary measures to ensure safe use in pediatric patients.

  • Verify that diarrhea is not caused by invasive bacterial infection before initiating therapy.
  • Assess hydration status and continue oral rehydration solutions alongside the medication.
  • Use with caution in children with known hypersensitivity to racecadotril or its excipients.
  • Monitor renal and hepatic function in patients with pre‑existing organ impairment.
  • Avoid prolonged use beyond the acute episode of diarrhea.
  • Do not substitute the drug for necessary antibiotic therapy when bacterial infection is confirmed.
  • Keep the product out of reach of children to prevent accidental ingestion.

Avoid Interactions

Racecadotril may interact with other medicines, affecting its efficacy or safety profile.

Avoid

  • Concomitant use with potent opioid agonists that act centrally, as they may mask symptoms and increase risk of respiratory depression.
  • Co‑administration with drugs that strongly inhibit renal excretion, potentially raising thiorphan levels.

Use with caution

  • Anticholinergic agents that can exacerbate constipation when combined.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs) in children with compromised renal function.
  • Other antidiarrheal agents such as loperamide, due to additive effects on intestinal motility.
  • Vaccines containing live attenuated viruses, although no direct interaction is documented, monitor clinical response.

Frequently Asked Questions

The active ingredient in Hidrasec Pro Děti is racecadotril, an enkephalinase inhibitor used to treat acute diarrhea in children.

Racecadotril reduces intestinal fluid secretion without affecting gut motility, whereas loperamide primarily slows intestinal transit. This makes racecadotril less likely to cause constipation in pediatric patients.

Yes, Hidrasec Pro Děti is intended to be used alongside oral rehydration solutions to maintain hydration while reducing stool output.

The regulatory status of Hidrasec Pro Děti varies by country within the European Union; it may be prescription‑only or available OTC depending on local regulations.

Hidrasec Pro Děti is formulated for pediatric use, typically indicated for children from infancy up to early adolescence, as specified by the prescribing information.

Common side effects include mild abdominal discomfort, nausea, transient headache, slight increases in serum creatinine, and occasional skin rash or pruritus.

Treatment should be stopped if diarrhea resolves, if severe adverse reactions occur, or if there is evidence of bacterial infection requiring antibiotics.

Racecadotril should be avoided with potent central opioid agonists and drugs that strongly inhibit renal excretion. Caution is advised when combined with anticholinergics, NSAIDs, other antidiarrheals, or live‑virus vaccines.

By inhibiting the enzyme enkephalinase, racecadotril increases endogenous enkephalins, which activate opioid receptors in the gut and decrease chloride and water secretion into the intestinal lumen.

Hidrasec Pro Děti is intended for short‑term use during acute diarrheal episodes and is not recommended for chronic diarrhea without medical supervision.

In children with renal impairment, monitor kidney function closely and use the medication only if the benefit outweighs potential risks, as racecadotril metabolites are renally excreted.

Racecadotril has a low risk of causing constipation because it does not significantly affect intestinal motility, but monitoring is advised if combined with other constipating agents.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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