What it's for (Indications)
- Racecadotril is indicated for the symptomatic treatment of acute diarrhea in infants, children, and adults.
- It is typically used as an adjunct to oral rehydration therapy (ORT).
- For infants and children, its use should be considered alongside ORT, especially when ORT alone is insufficient or when the child's general condition necessitates additional anti-secretory measures.
- It is important to note that racecadotril does not replace the necessity for rehydration.
- Its primary role is to reduce the volume and frequency of stools, thereby aiding in the management of fluid and electrolyte loss associated with diarrheal episodes.
- The duration of treatment should generally not exceed 7 days, and medical advice should be sought if symptoms persist or worsen.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | The dosage of racecadotril varies by age and body weight, and it is crucial to follow prescribed guidelines. For **adults**, the typical dosage is 100 mg taken three times daily, preferably before main meals. Treatment should be continued until two normal stools are passed, for a maximum of 7 days. For **infants and children**, racecadotril is available in granular form for oral suspension, allowing for precise weight-based dosing. The recommended dosage for pediatric patients is 1.5 mg/kg body weight, administered three times daily. For example, a 13-27 kg child might receive 30 mg three times daily, while an infant weighing less than 9 kg might receive 10 mg three times daily. The granules can be mixed with food, milk, or water and should be administered immediately after preparation. Regardless of age, adequate rehydration therapy must always accompany racecadotril treatment to prevent or correct dehydration and electrolyte imbalances, which are the primary risks associated with acute diarrhea. |
Safety & Warnings
Common Side Effects
- Racecadotril is generally well-tolerated, with most adverse effects being mild and transient.
- Common side effects reported include headache, nausea, vomiting, and constipation.
- Skin reactions such as rash and pruritus have also been observed.
- Less common but more serious adverse reactions may occur, requiring immediate medical attention.
- These include angioedema (swelling of the face, lips, tongue, or throat, which can cause difficulty breathing or swallowing), urticaria (hives), and erythema multiforme (a severe skin reaction characterized by target-like lesions).
- While rare, these hypersensitivity reactions can be severe and potentially life-threatening.
- Patients should be advised to discontinue the medication and seek urgent medical help if any signs of angioedema or severe skin reactions develop.
- Other infrequent side effects reported include dizziness and abdominal discomfort.
- Reporting of suspected adverse reactions after authorisation of the medicinal product is important.
Serious Warnings
- Black Box Warning: While racecadotril does not carry an FDA-mandated Black Box Warning, there have been post-marketing reports of angioedema (swelling beneath the skin, often involving the face, lips, tongue, or throat) in patients treated with racecadotril. This severe hypersensitivity reaction can manifest as laryngeal edema, which may be life-threatening due to potential airway obstruction. The risk of angioedema may be increased in patients with a history of angioedema or in those concomitantly receiving other medications known to cause angioedema, such as angiotensin-converting enzyme (ACE) inhibitors (e.g., lisinopril, enalapril). Patients should be thoroughly informed about the signs and symptoms of angioedema and advised to discontinue racecadotril immediately and seek urgent medical attention if any such symptoms occur. These symptoms include swelling of the face, periorbital area, tongue, glottis, or larynx, with or without dyspnea or dysphagia. Racecadotril should not be re-administered to patients who have experienced angioedema while on the drug. Healthcare providers should exercise caution and conduct a thorough patient history review, particularly regarding previous angioedema episodes and concomitant medication use, before initiating racecadotril therapy.
- Several important warnings should be considered when prescribing or administering racecadotril.
- Firstly, racecadotril is an adjunct to, not a replacement for, oral rehydration therapy (ORT).
- Proper rehydration is paramount in managing acute diarrhea to prevent life-threatening dehydration and electrolyte imbalances.
- Patients should be advised on the importance of consuming adequate fluids and electrolytes.
- Secondly, caution is advised in patients with renal or hepatic impairment, as there is limited clinical experience in these populations, and potential for drug accumulation exists.
- Thirdly, racecadotril is not indicated for chronic diarrhea or diarrhea associated with antibiotic use.
- It should also not be used in cases of bloody or purulent stools, high fever, or in diarrhea caused by invasive bacterial pathogens, as these conditions often require specific antimicrobial treatment.
- The presence of prolonged or uncontrolled vomiting may limit the effectiveness of oral racecadotril.
- Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take formulations containing sucrose.
How it Works (Mechanism of Action)
Racecadotril is a pro-drug that is rapidly metabolized in vivo to its active metabolite, thiorphan (acetorphan). Thiorphan is a selective and reversible inhibitor of enkephalinase, also known as neutral endopeptidase (NEP), which is an enzyme located on the brush border of intestinal epithelial cells. Enkephalinase is responsible for the degradation of endogenous opioid peptides, primarily enkephalins. By inhibiting enkephalinase, thiorphan prevents the breakdown of these naturally occurring enkephalins. Enkephalins exert an anti-secretory effect in the intestinal tract by binding to delta-opioid receptors on enterocytes, which in turn leads to a reduction in cyclic adenosine monophosphate (cAMP) levels. This reduction in intracellular cAMP decreases the secretion of water and electrolytes from the intestinal cells into the lumen, thereby reducing the volume and frequency of diarrheal stools. Crucially, racecadotril's action is purely anti-secretory and does not affect intestinal motility, nor does it alter normal basal secretory activity, thus avoiding the risk of secondary constipation.
Commercial Brands (Alternatives)
No other brands found for this formula.