Product image of Hidrasec (Racecadotril) supplied by GNH India

Hidrasec

Active Ingredient:
Racecadotril
Origin:
EU

Hidrasec (Racecadotril)

Hidrasec is a pharmaceutical product that contains the active ingredient racecadotril. It is marketed in the European Union as an oral antidiarrheal medication. The formulation is presented without a specified strength or dosage form, reflecting its status as a generic enkephalinase inhibitor. Hidrasec belongs to the therapeutic class of antidiarrheal agents and is intended for use in the management of acute diarrhea in adults and children.

Manufacturer / TM Owner

Bioprojet Europe Ltd

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Indications & Clinical Uses

Hidrasec is indicated for the symptomatic treatment of acute watery diarrhea in patients where rapid reduction of stool output is desired.

  • Adults experiencing acute infectious diarrhea, especially of bacterial origin.
  • Children with sudden onset of watery diarrhea, under medical supervision.
  • Patients receiving oral rehydration therapy who need adjunct antidiarrheal support.
  • Situations where a non‑opioid, enkephalinase‑inhibiting agent is preferred over anticholinergic agents.
  • Short‑term management of travel‑associated diarrhea to limit fluid loss.
  • Elderly patients with acute diarrhea who are at risk of dehydration.
  • Individuals with mild to moderate diarrhea where prescription‑only agents are not indicated.

How It Works

  • Racecadotril, the active component of Hidrasec, is an enkephalinase inhibitor that blocks the enzyme responsible for degrading endogenous enkephalins in the gastrointestinal tract. By preserving these opioid‑like peptides, the drug enhances their interaction with μ‑opioid receptors on enteric neurons, which leads to reduced cyclic AMP production and inhibition of chloride and water secretion into the intestinal lumen. This mechanism decreases intestinal fluid loss without markedly affecting gut motility.

Side Effects

Adverse reactions reported with Hidrasec are generally mild, but rare serious events have been described.

Common

  • Nausea or mild stomach discomfort, usually transient.
  • Transient abdominal pain or cramps that resolve without intervention.
  • Headache, often low‑intensity.
  • Flatulence or increased intestinal gas, sometimes accompanied by bloating.
  • Dizziness or light‑headed feeling, particularly when standing quickly.
  • Mild worsening of diarrhea in the first 24 hours.

Serious

  • Allergic skin reactions such as urticaria, rash, or angio‑edema.
  • Anaphylactic shock, a rare but life‑threatening hypersensitivity response.
  • Severe constipation that may progress to bowel obstruction.
  • Hepatic enzyme abnormalities indicating possible liver stress.
  • Persistent vomiting leading to risk of dehydration.
  • Acute renal impairment reported in isolated cases.

Precautions & Warnings

When considering Hidrasec, clinicians should evaluate several precautionary factors to ensure safe use.

  • Do not use Hidrasec in individuals with a documented allergy to racecadotril or any excipients.
  • Use with caution in patients who have moderate to severe renal or hepatic impairment, and adjust therapy as clinically indicated.
  • Pediatric use should follow age‑specific guidelines; it is generally not recommended for infants younger than two years without medical supervision.
  • Ensure that oral rehydration therapy is initiated before administering Hidrasec to prevent dehydration.
  • Avoid use in patients with active inflammatory bowel disease, such as ulcerative colitis or Crohn’s disease, unless specifically indicated.
  • Monitor electrolyte levels during prolonged therapy, especially in the elderly or those with comorbid conditions.

Avoid Interactions

Potential drug interactions with Hidrasec should be reviewed before initiating therapy.

Avoid

  • Concomitant use with other antidiarrheal agents that act on intestinal motility (e.g., loperamide) due to additive effect.
  • Combination with opioid analgesics may increase risk of constipation.
  • Use with potent CYP enzyme inhibitors if racecadotril metabolism is affected (though minimal).
  • Avoid simultaneous administration with anticholinergic agents as they may counteract the intended effect.

Use with caution

  • Co‑administration with diuretics may affect fluid balance.
  • Concurrent use of NSAIDs may increase risk of gastrointestinal discomfort.
  • Patients on antihypertensive drugs should be monitored for changes in blood pressure due to fluid shifts.
  • Caution when combined with antibiotics that alter gut flora, as diarrhea etiology may change.

Frequently Asked Questions

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

Racecadotril inhibits the enzyme enkephalinase, increasing endogenous enkephalins in the gut, which reduces intestinal secretion of water and electrolytes without significantly affecting motility.

Hidrasec is typically prescribed for adults and children who have acute watery diarrhea and need rapid reduction of stool output, often alongside oral rehydration therapy.

Yes, Hidrasec can be used in children, but dosing and age‑specific recommendations should follow pediatric guidelines and be supervised by a healthcare professional.

Common side effects include nausea, mild abdominal discomfort, headache, flatulence, dizziness, and a temporary increase in diarrhea during the first day of treatment.

Serious reactions are rare but may include allergic skin reactions, anaphylaxis, severe constipation, hepatic enzyme changes, persistent vomiting, and isolated cases of acute renal impairment.

Precautions include checking for allergy to racecadotril, assessing renal or hepatic function, confirming appropriate age for pediatric use, ensuring rehydration therapy is started, and reviewing any active inflammatory bowel disease.

Oral rehydration therapy should be initiated first to replace fluid losses, and Hidrasec can be added afterward to help reduce further stool output.

Avoid using Hidrasec together with other antidiarrheal agents such as loperamide, opioid analgesics, potent CYP inhibitors, and anticholinergic drugs that may counteract its effect.

Use caution when Hidrasec is combined with diuretics, NSAIDs, antihypertensive agents, or antibiotics that alter gut flora, as these may affect fluid balance or the underlying cause of diarrhea.

Safety data for Hidrasec during pregnancy are limited; the decision to use it should be made by a healthcare professional after evaluating potential benefits and risks.

Regulatory details for Hidrasec can be accessed through the European Medicines Agency (EMA) database or the national competent authority of the EU member state where the product is marketed.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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