Hidrasec (Racecadotril)

What Is Hidrasec and What Is It Used For?

Quick Answer: Hidrasec is a prescription antidiarrheal medicine containing racecadotril. It is used as add-on treatment for acute diarrhea in infants and children over 3 months, alongside oral rehydration therapy and appropriate dietary measures.

Hidrasec belongs to a class of medicines known as enkephalinase inhibitors. Its active ingredient, racecadotril, is a prodrug that is rapidly converted in the body to its active metabolite, thiorphan. Thiorphan inhibits enkephalinase, an enzyme located on the surface of intestinal epithelial cells. This enzyme normally breaks down naturally occurring opioid peptides called enkephalins, which play a role in regulating fluid secretion in the gut.

By preventing the breakdown of enkephalins, Hidrasec reduces the excessive secretion of water and electrolytes into the intestinal lumen that occurs during acute diarrhea. Importantly, this mechanism of action means that Hidrasec does not affect normal basal intestinal secretion or intestinal motility. This distinguishes it from antimotility agents such as loperamide, which slow gut movement and can cause complications such as abdominal distension, constipation, and rebound effects, particularly in young children.

Hidrasec is indicated for the symptomatic treatment of acute diarrhea in infants (over 3 months of age) and children, when oral rehydration therapy and standard dietary measures alone are not sufficient to control the diarrhea. It can also be used as a complementary treatment when the underlying cause of the diarrhea is being treated separately. Acute diarrhea in children is most commonly caused by viral gastroenteritis (particularly rotavirus and norovirus), and Hidrasec can help reduce the duration and severity of symptoms regardless of the underlying etiology.

Clinical trials have demonstrated that racecadotril, when used alongside oral rehydration solution (ORS), significantly reduces stool output, duration of diarrhea, and the need for intravenous rehydration compared to ORS alone. The European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) recognizes racecadotril as an effective adjunctive treatment option for acute gastroenteritis in children.

What Should You Know Before Taking Hidrasec?

Quick Answer: Hidrasec should not be used in children under 3 months, in those with known allergy to racecadotril, or in patients with certain sugar intolerances. Special caution is needed if there is blood or pus in stools, chronic diarrhea, or kidney/liver disease.

Contraindications

Do not give Hidrasec to your child if any of the following apply:

• Allergy to racecadotril or any of the other ingredients in the medicine (sucrose, colloidal anhydrous silica, polyacrylate dispersion, apricot flavor)
• Sugar intolerance: If your child has been told by a doctor that they have an intolerance to certain sugars, consult your doctor before giving Hidrasec, as it contains sucrose
• Previous severe skin reaction: If your child has ever developed a severe skin rash, skin peeling, blistering, or mouth sores after taking racecadotril
• Under 3 months of age: Hidrasec is not recommended for infants younger than 3 months

Warnings and Precautions

Talk to your doctor or pharmacist before starting Hidrasec treatment if your child has any of the following conditions or circumstances:

• Bloody or purulent diarrhea with fever: The presence of blood or pus in your child's stool, especially with fever, may indicate a bacterial infection that requires specific antibiotic treatment. Your doctor should evaluate the cause before prescribing Hidrasec.
• Chronic diarrhea or antibiotic-associated diarrhea: Hidrasec is intended for acute diarrhea only. Chronic diarrhea or diarrhea caused by antibiotics may require different management strategies.
• Kidney disease or impaired liver function: Limited data are available on the use of racecadotril in children with renal or hepatic impairment. Dose adjustments may be necessary.
• Prolonged or uncontrolled vomiting: If your child is vomiting frequently, oral medication may not be adequately absorbed, and intravenous rehydration may be required.
• Diabetes: Hidrasec 10 mg contains approximately 1 g of sucrose per sachet. If your doctor has prescribed more than 5 sachets of Hidrasec 10 mg per day (equivalent to more than 5 g of sucrose), this should be taken into account in the child's total daily sugar intake. Hidrasec 30 mg contains approximately 3 g of sucrose per sachet.

Pregnancy and Breastfeeding

While Hidrasec is primarily indicated for use in children, it is important to note that the use of racecadotril is not recommended during pregnancy or breastfeeding. There are insufficient data on the effects of racecadotril on human pregnancy or on the breastfed infant. If you are pregnant or breastfeeding and considering using any racecadotril-containing product, consult your doctor or pharmacist before use.

Driving and Operating Machinery

Hidrasec has no or negligible effect on the ability to drive and use machines. However, as this formulation is intended for children, this consideration is generally not applicable to the target patient population.

How Does Hidrasec Interact with Other Drugs?

Quick Answer: Hidrasec can interact with several medication classes, primarily by increasing the risk of angioedema. ACE inhibitors, angiotensin II receptor blockers, sacubitril, and certain immunosuppressants are the most clinically significant interactions.

Although racecadotril has a relatively favorable interaction profile compared to many other medicines, several drug classes have been identified that may increase the risk of angioedema when used concomitantly. It is essential to inform your doctor about all medicines your child is currently taking, has recently taken, or might take. This includes over-the-counter medicines, herbal products, and dietary supplements.

Clinically Significant Interactions

The following medicines may increase the risk of angioedema when taken together with Hidrasec. Racecadotril inhibits enkephalinase, which is identical to neutral endopeptidase (NEP). NEP is involved in the degradation of several vasoactive peptides, including bradykinin. Inhibition of bradykinin degradation is the likely mechanism by which the risk of angioedema is increased with certain concomitant medications.

Understanding the Interaction Mechanism

The common thread linking these interactions is the bradykinin pathway. Racecadotril inhibits neutral endopeptidase (NEP), which is one of the enzymes responsible for degrading bradykinin. Bradykinin is a potent vasodilator that can cause vascular permeability and, in excess, angioedema. When Hidrasec is combined with other drugs that also affect bradykinin metabolism (such as ACE inhibitors, which prevent bradykinin breakdown by a different pathway), the cumulative effect can lead to elevated bradykinin levels, increasing the risk of angioedema.

While these interactions are potentially serious, they are relatively uncommon in pediatric practice because the interacting drugs (ACE inhibitors, ARBs, DPP-4 inhibitors) are primarily prescribed to adults. Nevertheless, it is important for healthcare professionals and caregivers to be aware of these interactions, particularly in children receiving treatment for cardiac conditions or organ transplant recipients on immunosuppressive therapy.

What Is the Correct Dosage of Hidrasec?

Quick Answer: The recommended dose of Hidrasec is 1.5 mg/kg body weight per dose, given three times daily at evenly spaced intervals. The dosage depends on your child's weight. Treatment should continue until two normal bowel movements occur, but never longer than 7 days.

Always give Hidrasec exactly as your doctor has prescribed. If you are unsure, check with your doctor or pharmacist. Hidrasec comes as granules that should be swallowed. The granules can be mixed with food or stirred into water in a glass or baby bottle. Mix well and give immediately to your child. Do not prepare the mixture in advance.

Children (Hidrasec 10 mg and 30 mg)

The daily dosage is based on the child's body weight at 1.5 mg/kg per dose, given three times per day at regular intervals. The following table provides a practical dosing guide:

Adults

The 10 mg and 30 mg granule formulations of Hidrasec are specifically designed for infants and children. In several countries, racecadotril is also available as 100 mg capsules intended for adult use. The typical adult dose is 100 mg three times daily, taken before meals. Treatment should begin with a single 100 mg dose regardless of the time of day, followed by 100 mg three times daily at mealtimes. As with the pediatric formulation, adult treatment should not exceed 7 days. Consult your doctor for the appropriate adult formulation available in your region.

Elderly Patients

No dose adjustment is generally required for elderly patients using racecadotril capsules. However, elderly patients should be monitored more closely due to a potentially higher risk of adverse effects, particularly angioedema and dehydration. Adequate fluid intake should be maintained throughout treatment. As always, the prescribing physician should assess the benefit-risk ratio on an individual basis.

Missed Dose

If you forget to give your child a dose of Hidrasec, do not give a double dose to make up for the missed one. Simply continue with the next scheduled dose at the usual time. It is important to maintain even intervals between doses throughout the day to ensure consistent therapeutic effect.

Overdose

If your child has received more Hidrasec than prescribed, or if a child has accidentally ingested the medicine, contact your doctor, hospital, or poison control center immediately for an assessment of the risk and appropriate advice. While no specific antidote exists for racecadotril overdose, supportive care and monitoring are the standard approach. Clinical experience with overdose is limited, but no serious adverse events have been reported at doses several times higher than the recommended therapeutic dose in clinical studies.

Duration of Treatment

Your doctor will advise how long to continue Hidrasec. The general recommendation is to continue treatment until your child has had two normal bowel movements. Treatment should not exceed 7 days. If symptoms persist beyond 7 days, or if your child's condition worsens during treatment, consult your doctor promptly, as the diarrhea may have a cause that requires different management.

What Are the Side Effects of Hidrasec?

Quick Answer: Hidrasec is generally well tolerated. Uncommon side effects include tonsillitis, skin rash, and redness. Rare but serious side effects include angioedema (swelling of the face, lips, or throat) and severe skin reactions such as erythema multiforme and DRESS. Stop treatment immediately if these occur.

Like all medicines, Hidrasec can cause side effects, although not everybody gets them. Most side effects are mild and resolve on their own. However, some side effects are serious and require immediate medical attention.

Understanding the Safety Profile

The overall safety profile of racecadotril is considered favorable, particularly in the pediatric population. In clinical trials comparing racecadotril plus oral rehydration solution versus placebo plus oral rehydration solution, the incidence of adverse events was similar between the two groups. This suggests that many side effects attributed to racecadotril may actually be related to the underlying illness rather than the medicine itself.

The most clinically significant adverse effect is angioedema, which is related to the pharmacological mechanism of action. As an enkephalinase (NEP) inhibitor, racecadotril can affect bradykinin metabolism, potentially leading to vasodilation and increased vascular permeability. Angioedema can occur at any time during treatment and may present as swelling of the face, lips, tongue, throat, or extremities. While rare, angioedema can be life-threatening if it involves the airway.

Skin reactions, ranging from mild rash to more serious conditions like erythema multiforme and DRESS, have been reported primarily through post-marketing surveillance. DRESS is a particularly serious condition that typically presents 2–6 weeks after starting a medication and involves fever, widespread skin rash, lymphadenopathy, and involvement of internal organs. Although extremely rare with racecadotril, awareness of this potential reaction is important for prompt recognition and management.

Reporting Side Effects

If your child experiences any side effects while taking Hidrasec, including any not listed in this article, please report them to your doctor or pharmacist. You can also report suspected side effects directly to your national pharmacovigilance authority. Reporting side effects helps to continuously monitor the benefit-risk balance of medicines and contributes to drug safety for all patients.

How Should You Store Hidrasec?

Quick Answer: Store Hidrasec out of the sight and reach of children, at room temperature with no special storage conditions. Do not use after the expiry date printed on the sachet and outer packaging.

Proper storage of medicines is essential to maintain their effectiveness and safety. Follow these guidelines for storing Hidrasec:

• Keep out of sight and reach of children. Store the medicine in a safe place where children cannot access it.
• No special storage conditions are required. Hidrasec sachets can be stored at room temperature. There is no need for refrigeration.
• Check the expiry date. Do not use Hidrasec after the expiry date printed on the sachet (after "EXP") and on the outer packaging. The expiry date refers to the last day of that month.
• Once opened, use immediately. After opening a sachet, mix the granules with food or water and administer to your child right away. Do not store opened sachets.
• Disposal. Do not throw unused medicines in household waste or flush them down the drain. Ask your pharmacist how to dispose of medicines you no longer need. These measures help protect the environment.

What Does Hidrasec Contain?

Quick Answer: Hidrasec contains racecadotril as its active ingredient (10 mg or 30 mg per sachet). Inactive ingredients include sucrose, colloidal anhydrous silica, polyacrylate dispersion, and apricot flavoring.

Active Ingredient

The active substance in Hidrasec is racecadotril. Each sachet of Hidrasec 10 mg contains 10 mg of racecadotril. Each sachet of Hidrasec 30 mg contains 30 mg of racecadotril. Racecadotril (also known as acetorphan) is a thiorphan prodrug with the chemical name benzyl N-[3-(acetylthio)-2-benzylpropanoyl]glycinate.

Inactive Ingredients (Excipients)

• Sucrose: Used as a sweetening agent and carrier for the granules. Hidrasec 10 mg contains approximately 1 g of sucrose per sachet; Hidrasec 30 mg contains approximately 3 g per sachet. This is relevant for patients with diabetes or hereditary fructose intolerance.
• Colloidal anhydrous silica: Used as a flow agent to ensure uniform distribution of the granules.
• Polyacrylate dispersion 30%: Acts as a binding agent to maintain the integrity of the granules.
• Apricot flavoring: Added to improve the taste and palatability of the medicine for children.

Appearance and Pack Sizes

Hidrasec is supplied as white to off-white granules for oral suspension in individual sachets. Each pack may contain 10, 16, 20, 30, 50, or 100 sachets (hospital packs). Not all pack sizes may be available in your country. The product is manufactured by FERRER Internacional S.A. (Barcelona, Spain) or Sophartex (Vernouillet, France) and is marketed by Bioprojet Europe Ltd. (Dublin, Ireland).

International Brand Names

Racecadotril is marketed under different brand names across Europe and other regions. The medicine is known as Hidrasec in most European countries, including Austria, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Ireland, Latvia, Lithuania, Norway, Poland, Slovakia, Slovenia, Sweden, and the United Kingdom. In Spain and Germany, it is sold as Tiorfan; in Belgium and Luxembourg as Tiorfast; in Italy as Tiorfix; and in the Netherlands and Portugal as Tiorfan. Regardless of the brand name, the active ingredient and mechanism of action are identical.